Clinical Practice Guideline

Treating Tobacco Use and Dependence: 

2008 Update

Guideline Liaisons

Ernestine W. Murray, RN, BSN, MAS, (Project Officer), Agency for Healthcare Research

and Quality

Glenn Bennett, MPH, CHES, National Heart, Lung, and Blood Institute

Stephen Heishman, PhD, National Institute on Drug Abuse

Corinne Husten, MD, MPH, Centers for Disease Control and Prevention

Glen Morgan, PhD, National Cancer Institute

Christine Williams, MEd, Agency for Healthcare Research and Quality

Guideline Staff

Bruce A. Christiansen, PhD (Project Director)

Megan E. Piper, PhD (Project Scientist)

Victor Hasselblad, PhD (Project Statistician)

David Fraser, MS (Project Coordinator)

Wendy Theobald, PhD (Editorial Associate)

Michael Connell, BS (Database Manager)

Cathlyn Leitzke, MSN, RN-C (Project Researcher)

U.S. Department of Health and Human Services

Public Health Service

May 2008

Guideline Panel

Michael C. Fiore, MD, MPH 

(Panel Chair)

Carlos Roberto Jaén, MD, PhD, FAAFP 

(Panel Vice Chair)

Timothy B. Baker, PhD 

(Senior Scientist)

William C. Bailey, MD, FACP, FCCP

Neal L. Benowitz, MD

Susan J. Curry, PhD

Sally Faith Dorfman, MD, MSHSA

Erika S. Froelicher, PhD, RN, MA, MPH

Michael G. Goldstein, MD

Cheryl G. Healton, DrPH

Patricia Nez Henderson, MD, MPH

Richard B. Heyman, MD

Howard K. Koh, MD, MPH, FACP

Thomas E. Kottke, MD, MSPH

Harry A. Lando, PhD

Robert E. Mecklenburg, DDS, MPH

Robin J. Mermelstein, PhD

Patricia Dolan Mullen, DrPH

C. Tracy Orleans, PhD

Lawrence Robinson, MD, MPH

Maxine L. Stitzer, PhD

Anthony C. Tommasello, PhD, MS

Louise Villejo, MPH, CHES

Mary Ellen Wewers, PhD, MPH, RN

iii

Guideline Update Development and Use

The 2008 update to Treating Tobacco Use and Dependence, a Public Health 

Service-sponsored Clinical Practice Guideline, is the result of an extraordinary partnership among Federal Government and nonprofit organizations 

comprised of the Agency for Healthcare Research and Quality; Centers 

for Disease Control and Prevention; National Cancer Institute; National 

Heart, Lung, and Blood Institute; National Institute on Drug Abuse; Robert 

Wood Johnson Foundation; American Legacy Foundation; and University 

of Wisconsin School of Medicine and Public Health’s Center for Tobacco 

Research and Intervention. Each member of this consortium is dedicated 

to improving the Nation’s public health, and their participation in this collaboration clearly demonstrates a strong commitment to tobacco cessation.

This Guideline is an updated version of the 2000 Treating Tobacco Use and 

Dependence Guideline. It is the product of a private-sector panel of experts 

(“the Panel”), consortium representatives, and staff. The update was written 

to include new, effective clinical treatments for tobacco dependence that 

have become available since the 2000 Guideline was published. Treating 

Tobacco Use and Dependence: 2008 Update will make an important contribution to the quality of care in the United States and the health of the 

American people.

The Panel employed an explicit, science-based methodology and expert 

clinical judgment to develop recommendations on the treatment of tobacco use and dependence. Extensive literature searches were conducted, 

and critical reviews and syntheses were used to evaluate empirical evidence 

and significant outcomes. Peer reviews were undertaken and public comment invited to evaluate the validity, reliability, and utility of the Guideline 

for clinical practice. The Panel’s recommendations primarily are based on 

published, evidence-based research. When the evidence was incomplete or 

inconsistent in a particular area, the recommendations reflect the professional judgment of Panel members.

The recommendations herein may not be appropriate for use in all circumstances and are designed particularly for clinical settings. Decisions to 

adopt any particular recommendation must be made by clinicians in light 

of available resources and circumstances presented by individual patients 

and in light of new clinical information such as that provided by the U.S. 

Food and Drug Administration (FDA).
iv

This Public Health Service-sponsored Clinical Practice Guideline update 

gives hope to the 7 out of 10 smokers who visit a clinician each year. This 

Guideline urges every clinician, health plan, and health care institution to 

make treating tobacco dependence a top priority during these visits. Please 

ask your patients two key questions: “Do you smoke?” and “Do you want 

to quit?” followed by use of the recommendations in this Guideline.
v

Abstract

Treating Tobacco Use and Dependence: 2008 Update, a Public Health Service-sponsored Clinical Practice Guideline, is a product of the Tobacco Use 

and Dependence Guideline Panel (“the Panel”), consortium representatives, consultants, and staff. These 37 individuals were charged with the 

responsibility of identifying effective, experimentally validated tobacco dependence treatments and practices. The updated Guideline was sponsored 

by a consortium of eight Federal Government and nonprofit organizations: 

the Agency for Healthcare Research and Quality (AHRQ); Centers for 

Disease Control and Prevention (CDC); National Cancer Institute (NCI); 

National Heart, Lung, and Blood Institute (NHLBI); National Institute on 

Drug Abuse (NIDA); American Legacy Foundation; Robert Wood Johnson 

Foundation (RWJF); and University of Wisconsin School of Medicine and 

Public Health’s Center for Tobacco Research and Intervention (UW-CTRI). 

This Guideline is an updated version of the 2000 Treating Tobacco Use and 

Dependence: Clinical Practice Guideline that was sponsored by the U.S. 

Public Health Service, U. S. Department of Health and Human Services. 

An impetus for this Guideline update was the expanding literature on 

tobacco dependence and its treatment. The original 1996 Guideline was 

based on some 3,000 articles on tobacco treatment published between 

1975 and 1994. The 2000 Guideline entailed the collection and screening 

of an additional 3,000 articles published between 1995 and 1999. The 2008 

Guideline update screened an additional 2,700 articles; thus, the present 

Guideline update reflects the distillation of a literature base of more than 

8,700 research articles. Of course, this body of research was further reviewed to identify a much smaller group of articles that served as the basis 

for focused Guideline data analyses and review. 

This Guideline contains strategies and recommendations designed to assist clinicians; tobacco dependence treatment specialists; and health care 

administrators, insurers, and purchasers in delivering and supporting 

effective treatments for tobacco use and dependence. The recommendations were made as a result of a systematic review and meta-analysis of 11 

specific topics identified by the Panel (proactive quitlines; combining counseling and medication relative to either counseling or medication alone; 

varenicline; various medication combinations; long-term medications; cessation interventions for individuals with low socioeconomic status/limited 
vi

formal education; cessation interventions for adolescent smokers; cessation 

interventions for pregnant smokers; cessation interventions for individuals with psychiatric disorders, including substance use disorders; providing cessation interventions as a health benefit; and systems interventions, 

including provider training and the combination of training and systems 

interventions). The strength of evidence that served as the basis for each 

recommendation is indicated clearly in the Guideline update. A draft of the 

Guideline update was peer reviewed prior to publication, and the input of 

81 external reviewers was considered by the Panel prior to preparing the 

final document. In addition, the public had an opportunity to comment 

through a Federal Register review process. The key recommendations of the 

updated Guideline, Treating Tobacco Use and Dependence: 2008 Update, 

based on the literature review and expert Panel opinion, are as follows:

 Ten Key Guideline Recommendations

The overarching goal of these recommendations is that clinicians strongly 

recommend the use of effective tobacco dependence counseling and 

medication treatments to their patients who use tobacco, and that health 

systems, insurers, and purchasers assist clinicians in making such effective 

treatments available.

1. Tobacco dependence is a chronic disease that often requires repeated 

intervention and multiple attempts to quit. Effective treatments exist, 

however, that can significantly increase rates of long-term abstinence.

2. It is essential that clinicians and health care delivery systems consistently 

identify and document tobacco use status and treat every tobacco user 

seen in a health care setting. 

3. Tobacco dependence treatments are effective across a broad range of 

populations. Clinicians should encourage every patient willing to make 

a quit attempt to use the counseling treatments and medications recommended in this Guideline. 

4. Brief tobacco dependence treatment is effective. Clinicians should offer 

every patient who uses tobacco at least the brief treatments shown to be 

effective in this Guideline.
vii

5. Individual, group, and telephone counseling are effective, and their 

effectiveness increases with treatment intensity. Two components of 

counseling are especially effective, and clinicians should use these when 

counseling patients making a quit attempt:

•	 Practical counseling (problemsolving/skills training)

•	 Social support delivered as part of treatment

6. Numerous effective medications are available for tobacco dependence, 

and clinicians should encourage their use by all patients attempting to 

quit smoking—except when medically contraindicated or with specific 

populations for which there is insufficient evidence of effectiveness (i.e., 

pregnant women, smokeless tobacco users, light smokers, and adolescents). 

•	 Seven first-line medications (5 nicotine and 2 non-nicotine) reliably

increase long-term smoking abstinence rates:

– Bupropion SR

– Nicotine gum

– Nicotine inhaler

– Nicotine lozenge

– Nicotine nasal spray

– Nicotine patch

– Varenicline 

•	 Clinicians also should consider the use of certain combinations of

medications identified as effective in this Guideline.

7. Counseling and medication are effective when used by themselves 

for treating tobacco dependence. The combination of counseling and 

medication, however, is more effective than either alone. Thus, clinicians should encourage all individuals making a quit attempt to use both 

counseling and medication. 

8. Telephone quitline counseling is effective with diverse populations and 

has broad reach. Therefore, both clinicians and health care delivery 

systems should ensure patient access to quitlines and promote quitline 

use. 
viii

9. If a tobacco user currently is unwilling to make a quit attempt, clinicians should use the motivational treatments shown in this Guideline 

to be effective in increasing future quit attempts. 

10. Tobacco dependence treatments are both clinically effective and highly 

cost-effective relative to interventions for other clinical disorders. Providing coverage for these treatments increases quit rates. Insurers and 

purchasers should ensure that all insurance plans include the counseling and medication identified as effective in this Guideline as covered 

benefits. 

The updated Guideline is divided into seven chapters that provide an 

overview, including methods (Chapter 1); information on the assessment 

of tobacco use (Chapter 2); clinical interventions, both for patients 

willing and unwilling to make a quit attempt at this time (Chapter 3); 

intensive interventions (Chapter 4); systems interventions for health 

care administrators, insurers, and purchasers (Chapter 5); the scientific 

evidence supporting the Guideline recommendations (Chapter 6); and 

information relevant to specific populations and other topics (Chapter 7).

A comparison of the findings of the updated Guideline with the 2000 

Guideline reveals the considerable progress made in tobacco research over 

the brief period separating these two publications. Tobacco dependence 

increasingly is recognized as a chronic disease, one that typically requires 

ongoing assessment and repeated intervention. In addition, the updated 

Guideline offers the clinician many more effective treatment strategies 

than were identified in the original Guideline. There now are seven different first-line effective agents in the smoking cessation pharmacopoeia, 

allowing the clinician and patient many different medication options. In 

addition, recent evidence provides even stronger support for counseling 

(both when used alone and with other treatments) as an effective tobacco 

cessation strategy; counseling adds to the effectiveness of tobacco cessation 

medications, quitline counseling is an effective intervention with a broad 

reach, and counseling increases tobacco cessation among adolescent smokers. 

Finally, there is increasing evidence that the success of any tobacco dependence treatment strategy cannot be divorced from the health care system 

in which it is embedded. The updated Guideline contains new evidence 

that health care policies significantly affect the likelihood that smokers 
ix

will receive effective tobacco dependence treatment and successfully stop 

tobacco use. For instance, making tobacco dependence treatment a covered 

benefit of insurance plans increases the likelihood that a tobacco user will 

receive treatment and quit successfully. Data strongly indicate that effective 

tobacco interventions require coordinated interventions. Just as the clinician must intervene with his or her patient, so must the health care administrator, insurer, and purchaser foster and support tobacco intervention 

as an integral element of health care delivery. Health care administrators 

and insurers should ensure that clinicians have the training and support to 

deliver consistent, effective intervention to tobacco users.

One important conclusion of this Guideline update is that the most effective way to move clinicians to intervene is to provide them with information regarding multiple effective treatment options and to ensure that they 

have ample institutional support to use these options. Joint actions by clinicians, administrators, insurers, and purchasers can encourage a culture of 

health care in which failure to intervene with a tobacco user is inconsistent 

with standards of care. 

gh

This document is in the public domain and may be used and reprinted 

without special permission. The Public Health Service appreciates citation 

as to source, and the suggested format is provided below:

Fiore MC, Jaén CR, Baker TB, et al. Treating Tobacco Use and Dependence: 

2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department 

of Health and Human Services. Public Health Service. May 2008. 

The complete Guideline author list can be found on the title page.
x

Acknowledgments

This Guideline would not have been possible without the collaborative efforts of many individuals and organizations. Each made significant contributions throughout the process of updating this document. Although too 

numerous to list here, the Contributors section of this publication provides 

a listing of support staff, individual peer reviewers, and others. Some individuals and organizations, however, deserve special mention.

The Panel wishes to acknowledge the support and guidance provided by 

the consortium partners in general and their dedicated, hard-working 

representatives in particular. In addition to the Guideline Liaisons, the 

Panel gratefully acknowledges the extraordinarily supportive efforts and 

substantial contributions of Jean Slutsky, Director, Center for Outcomes 

and Evidence, AHRQ, and the staff at the Office of Communications and 

Knowledge Transfer, AHRQ; Sandra Cummings, Deputy Director of Operations, Publishing Team; Harriett Bennett, Public Affairs and Marketing 

Specialist; and Julius Patterson, Guideline Managing Editor.

The Panel also wishes to thank Victor Hasselblad, PhD, who served the 

project as statistical consultant. 
xi

Contents

Executive Summary ........................................................................................ 1

1. Overview and Methods ............................................................................ 11

Introduction ..................................................................................................11

Rationale for Guideline Development and Periodic Updates.................12

Tobacco Dependence as a Chronic Disease...............................................15

Coordination of Care: Institutionalizing the Treatment of 

 Tobacco Dependence.................................................................................16

Guideline Development Methodology.......................................................16

 Introduction .............................................................................................16

 Topics Included in the Guideline...........................................................17 

 Guideline Development Process............................................................19 

 Selection of Evidence...............................................................................19

 Literature Review and Inclusion Criteria .............................................21

 Preparation of Evidence Tables .............................................................22

 Outcome Data ..........................................................................................23

 Meta-Analytic Techniques......................................................................24

 How To Read the Data Tables................................................................28

 Strength of Evidence................................................................................29

 Caveats Regarding Recommendations..................................................30

 External Review of the Guideline ..........................................................31 

Organization of the Guideline Update .......................................................32

 Link to References ...................................................................................33

2. Assessment of Tobacco Use...................................................................... 35

3. Clinical Interventions for Tobacco Use and Dependence ......................... 37

Background ..................................................................................................37

A. For the Patient Willing To Quit .............................................................40

B. For the Patient Unwilling To Quit.........................................................57

C. For the Patient Who Has Recently Quit ...............................................60

 

4. Intensive Interventions for Tobacco Use and Dependence ...................... 63

Background ..................................................................................................63

Strategies for Intensive Tobacco Dependence Intervention ....................64
xii

5. Systems Interventions—Importance to Health Care 

Administrators, Insurers, and Purchasers................................................ 67

Background ..................................................................................................67

Cost-Effectiveness of Tobacco Use Treatments.........................................68

Recommendations for Health Care Administrators, Insurers, 

 and Purchasers.............................................................................................69

Strategies for Health Care Administrators, Insurers, 

 and Purchasers.............................................................................................70

6. Evidence and Recommendations............................................................. 73

Background ..................................................................................................73

A. Counseling and Psychosocial Evidence ................................................77

 1. Screening and Assessment..................................................................77

 2. Treatment Structure and Intensity ....................................................82

Advice to Quit Smoking..................................................................82

Intensity of Clinical Interventions.................................................83

Type of Clinician............................................................................. 87

Formats of Psychosocial Treatments.............................................88 

 Self-help.......................................................................................89

 Quitlines......................................................................................91 

 Individually Tailored and Stepped-Care Interventions ........92

 Computerized Interventions....................................................93

Followup Assessment and Procedures..........................................94

 3. Treatment Elements............................................................................96 

 Combining Counseling and Medication....................................... 101

 For Smokers Not Willing To Make a Quit Attempt At 

This Time........................................................................................ 104

B. Medication Evidence ............................................................................ 106

 Recommendations Regarding Individual Medications: 

 First-Line Medications....................................................................... 108

 Recommendations Regarding Second-Line Medications............... 116

 Combination Medications................................................................... 118

 Relative Effectiveness of Medications ................................................ 120

Precessation NRT Use .................................................................. 122

 Medications Not Recommended by the Guideline Panel................ 124

Extended Use of Medications...................................................... 126 

 Use of Over-the-Counter Medications .............................................. 128

C. Systems Evidence .................................................................................. 130

 Clinician Training and Reminder Systems........................................ 130

 Cost-Effectiveness of Tobacco Dependence Interventions............. 134
xiii

 Tobacco Dependence Treatment as a Part of Assessing Health 

 Care Quality ........................................................................................ 138 

 Providing Treatment for Tobacco Use and Dependence as a 

 Covered Benefit................................................................................... 139

7. Specific Populations and Other Topics................................................... 143

Background ............................................................................................... 143

Effective Treatments for Specific Populations ........................................ 143

Clinical Issues for Specific Populations................................................... 148

 HIV-Positive Smokers.......................................................................... 148

 Hospitalized Smokers........................................................................... 149

 Lesbian/Gay/Bisexual/Transgender (LGBT) Smokers..................... 151

 Low SES/Limited Formal Education.................................................. 151

 Medical Comorbid Conditions, Including Cancer, Cardiac 

 Disease, COPD, Diabetes, and Asthma ........................................... 152

 Older Smokers....................................................................................... 153

 Psychiatric Disorders, Including Substance Use Disorders ............ 153

 Racial and Ethnic Minority Populations ........................................... 155

 Women ............................................................................................... 156

Other Specific Populations and Topics.................................................... 157

 Children and Adolescents.................................................................... 157

 Light Smokers....................................................................................... .162

 Noncigarette Tobacco Users................................................................ 163

 Pregnant Smokers................................................................................. 165

 Weight Gain After Stopping Smoking................................................ 173

 Exercise .................................................................................................. 173

Glossary...................................................................................................... 177

Contributors ............................................................................................... 195

Appendixes

A. Financial Disclosure for Panel Members, Liaisons, and 

 Peer Reviewers .................................................................................... 223 

B. Helpful Web Site Addresses.................................................................. 229

C. Coding Information Regarding the Diagnosis of and Billing 

 for Tobacco Dependence Treatment................................................ 231

D. Key Recommendation Changes From the 2000 PHS-

 Sponsored Clinical Practice Guideline: Treating Tobacco 

 Use and Dependence.......................................................................... 241

Index .......................................................................................................... 251
xiv

Tables

1.1. Topics chosen by the 2008 Guideline Panel for updated 

meta-analysis............................................................................................ 18

1.2. Relation between maternal smoking and low birth-weight 

in infants................................................................................................... 27 

1.3. Meta-analysis (2008): Effectiveness of and estimated abstinence 

rates for proactive telephone counseling compared to minimal 

interventions, self-help, or no counseling ............................................ 28

3.1. The “5 A’s” model for treating tobacco use and dependence ............. 39 

3.2. Clinical guidelines for prescribing medication for treating 

tobacco use and dependence.................................................................. 44 

3.3. Clinical use of bupropion SR ................................................................. 46 

3.4. Clinical use of nicotine gum .................................................................. 47

3.5. Clinical use of the nicotine inhaler....................................................... 49

3.6. Clinical use of the nicotine lozenge ...................................................... 50

3.7. Clinical use of the nicotine nasal spray ................................................ 51

3.8. Clinical use of the nicotine patch.......................................................... 52 

3.9. Clinical use of varenicline ...................................................................... 53

3.10. Clinical use of clonidine ......................................................................... 55

3.11. Clinical use of nortriptyline ................................................................... 56

4.1. Findings relevant to intensive interventions........................................ 65

4.2. Components of an intensive tobacco dependence intervention ....... 65

6.1. Topics meta-analyzed for the 2008 Guideline update ........................ 74

6.2. Topics meta-analyzed for the 1996 and 2000 Guidelines and 

included in the 2008 Guideline update (but not re-analyzed)........... 75

6.3. Summary of strength of evidence for recommendations................... 77 

6.4. Meta-analysis (1996): Impact of having a tobacco use status 

identification system in place on rates of clinician intervention 

with their patients who smoke............................................................... 78 

6.5. Meta-analysis (1996): Impact of having a tobacco use status 

identification system in place on abstinence rates among 

patients who smoke................................................................................. 79

6.6. Variables associated with higher or lower abstinence rates............... 81

6.7. Meta-analysis (1996): Effectiveness of and estimated abstinence 

rates for advice to quit by a physician................................................... 83

6.8. Meta-analysis (2000): Effectiveness of and estimated abstinence 

rates for various intensity levels of session length............................... 84

6.9. Meta-analysis (2000): Effectiveness of and estimated abstinence 

rates for total amount of contact time .................................................. 85
xv

6.10. Meta-analysis (2000): Effectiveness of and estimated abstinence 

rates for number of person-to-person treatment sessions................. 86 

6.11. Meta-analysis (2000): Effectiveness of and estimated abstinence 

rates for interventions delivered by different types of clinicians....... 88

6.12. Meta-analysis (2000): Effectiveness of and estimated abstinence 

rates for interventions delivered by various numbers of clinician 

types .......................................................................................................... 88

6.13. Meta-analysis (2000): Effectiveness of and estimated abstinence 

rates for various types of formats .......................................................... 90

6.14. Meta-analysis (2000): Effectiveness of and estimated abstinence 

rates for number of formats ................................................................... 91

6.15. Meta-analysis (2000): Effectiveness of and estimated abstinence 

rates for number of types of self-help ................................................... 91

6.16. Meta-analysis (2008): Effectiveness of and estimated abstinence 

rates for quitline counseling compared to minimal interventions, 

self-help, or no counseling ..................................................................... 92

6.17. Meta-analysis (2008): Effectiveness of and estimated abstinence 

rates for quitline counseling and medication compared to 

medication alone ..................................................................................... 92

6.18. Meta-analysis (2000): Effectiveness of and estimated abstinence 

rates for various types of counseling and behavioral therapies......... 97

6.19. Common elements of practical counseling (problemsolving/ 

skills training).......................................................................................... 98

6.20. Common elements of intratreatment supportive interventions ....... 99

6.21. Meta-analysis (2000): Effectiveness of and estimated abstinence 

rates for acupuncture ............................................................................ 100

6.22. Meta-analysis (2008): Effectiveness of and estimated abstinence 

rates for the combination of counseling and medication vs. 

medication alone ................................................................................... 102 

6.23. Meta-analysis (2008): Effectiveness of and estimated abstinence 

rates for the number of sessions of counseling in combination 

with medication vs. medication alone ................................................ 102 

6.24. Meta-analysis (2008): Effectiveness of and estimated abstinence 

rates for the combination of counseling and medication vs. 

counseling alone .................................................................................... 103

6.25. Coding rules for medication duration and dose ............................... 108

6.26. Meta-analysis (2008): Effectiveness and abstinence rates for 

various medications and medication combinations compared 

to placebo at 6-months postquit.......................................................... 109
xvi

6.27. Effectiveness of the nicotine lozenge: Results from the single 

randomized controlled trial ................................................................. 112

6.28. Meta-analysis (2008): Effectiveness of and abstinence rates of 

medications relative to the nicotine patch ......................................... 121

6.29. Meta-analysis (2008): Effectiveness of and abstinence rates for 

smokers not willing to quit (but willing to change their smoking 

patterns or reduce their smoking) after receiving NRT compared 

to placebo................................................................................................ 124

6.30. Meta-analysis (2000): Effectiveness of and estimated abstinence 

rates for OTC nicotine patch therapy ................................................. 129 

6.31. Meta-analysis (2008): Effectiveness of and estimated abstinence 

rates for clinician training .................................................................... 130 

6.32. Meta-analysis (2008): Effectiveness of clinician training on rates 

of providing treatment (“Assist”)......................................................... 131

6.33. Meta-analysis (2008): Effectiveness of clinician training combined 

with charting on asking about smoking status (“Ask”)..................... 131

6.34. Meta-analysis (2008): Effectiveness of training combined with 

charting on setting a quit date (“Assist”) ............................................ 132

6.35. Meta-analysis (2008): Effectiveness of training combined with 

charting on providing materials (“Assist”)......................................... 132

6.36. Meta-analysis (2008): Effectiveness of training combined with 

charting on arranging for followup (“Arrange”)................................ 132

6.37. Meta-analysis (2008): Estimated rates of intervention for 

individuals who received tobacco use interventions as a 

covered health insurance benefit......................................................... 140 

6.38. Meta-analysis (2008): Estimated rates of quit attempts for 

individuals who received tobacco use interventions as a 

covered health insurance benefit......................................................... 140

6.39. Meta-analysis (2008): Estimated abstinence rates for individuals 

who received tobacco use interventions as a covered benefit.......... 140 

7.1. Evidence of effectiveness of tobacco dependence interventions 

in specific populations.......................................................................... 144

7.2. Clinical issues for treating specific populations................................ 148

7.3. Suggested interventions for hospitalized patients............................. 150

7.4. Meta-analysis (2008): Effectiveness of and estimated abstinence 

rates for counseling interventions with adolescent smokers........... 159 

7.5. Meta-analysis (2008): Effectiveness of and estimated 

preparturition abstinence rates for psychosocial 

interventions with pregnant smokers................................................. 166 
xvii

7.6. Examples of effective psychosocial interventions with 

pregnant patients................................................................................... 167

7.7. Clinical practice suggestions for assisting a pregnant patient 

in stopping smoking.............................................................................. 167

7.8. Meta-analysis (2008): Effectiveness of and estimated 

preparturition abstinence rates for self-help interventions 

with pregnant smokers.......................................................................... 169 

7.9. Clinician statements to help a patient prepare for and cope 

with postcessation weight gain ............................................................ 176

Strategies

Strategy A1. Ask—Systematically identify all tobacco users at 

 every visit......................................................................................................... 40

Strategy A2. Advise—Strongly urge all tobacco users to quit...................... 41

Strategy A3. Assess—Determine willingness to make a quit attempt......... 41

Strategy A4. Assist—Aid the patient in quitting (provide counseling 

 and medication).............................................................................................. 42

Strategy A5. Arrange—Ensure followup contact........................................... 43

Strategy B1. Motivational interviewing strategies......................................... 58

Strategy B2. Enhancing motivation to quit tobacco—the “5 R’s”................ 59

Strategy C1. Intervening with the patient who has recently quit................ 61

Strategy C2. Addressing problems encountered by former smokers ......... 61

Systems Strategy 1. Implement a tobacco user identification system 

 in every clinic.................................................................................................. 70

Systems Strategy 2. Provide education, resources, and feedback to 

 promote provider intervention..................................................................... 71

Systems Strategy 3. Dedicate staff to provide tobacco dependence 

 treatment, and assess the delivery of this treatment in staff performance 

 evaluations....................................................................................................... 71

Systems Strategy 4. Promote hospital policies that support and provide 

 inpatient tobacco dependence services ....................................................... 72

Systems Strategy 5. Include tobacco dependence treatments (both 

 counseling and medication) identified as effective in this Guideline as 

 paid or covered services for all subscribers or members of health 

 insurance packages......................................................................................... 72

Figures

1.1.	 2008 Guideline development process...................................................20

1.2.	 Model for treatment of tobacco use and dependence .........................34

2.1.	 Algorithm for treating tobacco use ......................................................36

1

Executive Summary

Context

The 1996 Smoking Cessation Clinical Practice Guideline1 emphasized the 

dire health consequences of tobacco use and dependence, the existence 

of effective treatments, and the importance of inducing more smokers to 

use such treatments. It also called for newer, even more effective tobacco 

dependence treatments. All of these points still are germane. Nevertheless, heartening progress has been made in tobacco control since that time, 

and this progress is part of a larger pattern of change that stretches back 

over the past 40 years. This progress reflects the achievements of clinicians, 

the public health community, scientists, government agencies, health care 

organizations, insurers, purchasers, and smokers who have successfully 

quit. As a result, the current prevalence of tobacco use among adults in the 

United States (about 20.8%) is less than half the rate observed in the 1960s 

(about 44%).2,3

This Guideline concludes that tobacco use presents a rare confluence of 

circumstances: (1) a highly significant health threat;4 (2) a disinclination 

among clinicians to intervene consistently;5 and (3) the presence of effective interventions. This last point is buttressed by evidence that tobacco 

dependence interventions, if delivered in a timely and effective manner, 

significantly reduce the smoker’s risk of suffering from smoking-related 

disease.6-13 Indeed, it is difficult to identify any other condition that presents such a mix of lethality, prevalence, and neglect, despite effective and 

readily available interventions. 

Although tobacco use still is an enormous threat, the story of tobacco control efforts during the last half century is one of remarkable progress and 

promise. In 1965, current smokers outnumbered former smokers three to 

one.14 During the past 40 years, the rate of quitting has so outstripped the 

rate of initiation that, today, there are more former smokers than current 

smokers.15 Moreover, 40 years ago smoking was viewed as a habit rather 

than a chronic disease. No scientifically validated treatments were available 

for the treatment of tobacco use and dependence, and it had little place in 

health care delivery. Today, numerous effective treatments exist, and tobacco use assessment and intervention are considered to be requisite duties 
2

of clinicians and health care delivery entities. Finally, every state now has a 

telephone quitline, increasing access to effective treatment.

The scant dozen years following the publication of the first Guideline have 

ushered in similarly impressive changes. In 1997, only 25 percent of managed health care plans covered any tobacco dependence treatment; this 

figure approached 90 percent by 2003,16 although this increased coverage 

often includes barriers to use. Numerous states added Medicaid coverage 

for tobacco dependence treatment since the publication of the first Guideline so that, by 2005, 72 percent offered coverage for at least one Guidelinerecommended treatment.16-18 In 2002, The Joint Commission (formerly 

JCAHO), which accredits some 15,000 hospitals and health care programs, 

instituted an accreditation requirement for the delivery of evidence-based 

tobacco dependence interventions for patients with diagnoses of acute 

myocardial infarction, congestive heart failure, or pneumonia (www.

coreoptions.com/new_site/jcahocore.html; hospital-specific results: www.

hospitalcompare.hhs.gov). Finally, Medicare, the Veterans Health Administration, and the United States Military now provide coverage for tobacco 

dependence treatment. Such policies and systems changes are paying off in 

terms of increased rates of assessment and treatment of tobacco use. 

Data show that the rate at which smokers report being advised to quit 

smoking has approximately doubled since the early 1990s.19-22 Recent data 

also suggest a substantial increase in the proportion of smokers receiving 

more intensive cessation interventions.23,24 The National Committee for 

Quality Assurance (NCQA) reports steady increases for both commercial 

insurers and Medicaid in the discussion of both medications and strategies 

for smoking cessation.25 Finally, since the first Guideline was published in 

1996, smoking prevalence among adults in the United States has declined 

from about 25 percent to about 21 percent.26

An inspection of the 2008 Guideline update shows that substantial progress also has been made in treatment development and delivery. Telephone 

quitlines have been shown to be effective in providing wide access to evidence-based cessation counseling.27,28 Seven U.S. Food and Drug Administration (FDA)-approved medications for treating tobacco dependence are 

now available, and new evidence has revealed that particular medications 

or combinations of medications are especially effective. 
3

This Guideline update also casts into stark relief those areas in which more 

progress is needed. There is a need for innovative and more effective counseling strategies. In addition, although adolescents appear to benefit from 

counseling, more consistent and effective interventions and options for use 

with children, adolescents, and young adults clearly are needed. Smoking 

prevalence remains discouragingly high in certain populations, such as in 

those with low socioeconomic status (SES)/low educational attainment, 

some American Indian populations, and individuals with psychiatric disorders, including substance use disorders.3

 New techniques and treatment 

delivery strategies may be required before the needs of these groups are 

adequately addressed. Moreover, although much of the available data come 

from randomized clinical trials occurring in research settings, it is imperative that new research examine implementation of effective treatments 

in real-world clinical settings. Finally, new strategies are needed to create 

consumer demand for effective treatments among tobacco users; there has 

been little increase in the proportion of smokers who make quit attempts, 

and too few smokers who do try to quit take advantage of evidence-based 

treatment that can double or triple their odds of success.29 New research 

and communication efforts must impart greater hope, confidence, and increased access to treatments so that tobacco users in ever greater numbers 

attempt tobacco cessation and achieve abstinence. To succeed, all of these 

areas require adequate funding.

Thus, this 2008 Guideline update serves as a benchmark of the progress 

made. It should reassure clinicians, policymakers, funding agencies, and 

the public that tobacco use is amenable to both scientific analysis and clinical interventions. This history of remarkable progress should encourage 

renewed efforts by clinicians, policymakers, and researchers to help those 

who remain dependent on tobacco. 

Guideline Origins

This Guideline, Treating Tobacco Use and Dependence: 2008 Update, a Public Health Service-sponsored Clinical Practice Guideline, is the product of 

the Treating Tobacco Use and Dependence Guideline Panel (“the Panel”), 

government liaisons, consultants, and staff. These individuals were charged 

with the responsibility of identifying effective, experimentally validated tobacco dependence clinical treatments and practices. This Guideline update 

is the third Public Health Service Clinical Practice Guideline published on 
4

tobacco use. The first Guideline, the 1996 Smoking Cessation Clinical Practice Guideline No. 18, was sponsored by the Agency for Healthcare Policy 

and Research (AHCPR, now the Agency for Healthcare Research and 

Quality [AHRQ]), U.S. Department of Health and Human Services (HHS). 

That Guideline reflected scientific literature published between 1975 and 

1994. The second Guideline, published in 2000, Treating Tobacco Use and 

Dependence, was sponsored by a consortium of U. S. Public Health Service (PHS) agencies (AHRQ; Centers for Disease Control and Prevention 

[CDC]; National Cancer Institute [NCI]; National Heart, Lung, and Blood 

Institute [NHLBI]; National Institute on Drug Abuse [NIDA]) as well as 

the Robert Wood Johnson Foundation (RWJF) and the University of Wisconsin Center for Tobacco Research and Intervention (UW-CTRI). That 

Guideline reflected the scientific literature published from 1975 to 1999. 

The current 2008 update addresses literature published from 1975 to 2007.

The updated Guideline was written in response to new, effective clinical 

treatments for tobacco dependence that have been identified since 1999. 

These treatments promise to enhance the rates of successful tobacco cessation. The original 1996 Guideline was based on some 3,000 articles on 

tobacco treatment published between 1975 and 1994. The 2000 Guideline 

required the collection and screening of an additional 3,000 articles published between 1995 and 1999. The 2008 Guideline update screened an 

additional 2,700 articles; thus, the present Guideline update reflects the 

distillation of a literature base of more than 8,700 research articles. This 

body of research of course was further reviewed to identify a much smaller 

group of articles, based on rigorous inclusion criteria, which served as the 

basis for focused Guideline data analyses and review. 

The 2008 updated Guideline was sponsored by a consortium of eight Federal Government and private nonprofit organizations: AHRQ, CDC, NCI, 

NHLBI, NIDA, American Legacy Foundation, RWJF, and UW-CTRI. All 

of these organizations have as their mission reducing the human costs of 

tobacco use. Given the importance of this issue to the health of all Americans, the updated Guideline is published by the PHS, HHS.

Guideline Style and Structure

This Guideline update was written to be applicable to all tobacco users—

those using cigarettes as well as other forms of tobacco. Therefore, the 

terms “tobacco user” and “tobacco dependence” will be used in prefer-
5

ence to “smoker” and “cigarette dependence.” In some cases, however, the 

evidence for a particular recommendation consists entirely of studies using 

cigarette smokers as participants. In these instances, the recommendation 

and evidence refers to “smoking” to communicate the parochial nature 

of the evidence. In most cases, though, Guideline recommendations are 

relevant to all types of tobacco users. Finally, most data reviewed in this 

Guideline update are based on adult smokers, although data relevant to 

adolescent smokers are presented in Chapter 7.

The updated Guideline is divided into seven chapters that integrate prior 

and updated findings: 

Chapter 1, Overview and Methods, provides the clinical practice and 

scientific context of the Guideline update project and describes the 

methodology used to generate the Guideline findings.

Chapter 2, Assessment of Tobacco Use, describes how each patient 

presenting at a health care setting should have his or her tobacco use status 

determined and how tobacco users should be assessed for willingness to 

make a quit attempt. 

Chapter 3, Clinical Interventions for Tobacco Use and Dependence, 

summarizes effective brief interventions that can easily be delivered in a 

primary care setting. In this chapter, separate interventions are described 

for the patient who is willing to try to quit at this time, for the patient who 

is not yet willing to try to quit, and for the patient who has recently quit.

Chapter 4, Intensive Interventions for Tobacco Use and Dependence, 

outlines a prototype of an intensive tobacco cessation treatment that 

comprises strategies shown to be effective in this Guideline. Because 

intensive treatments produce the highest success rates, they are an 

important element in tobacco intervention strategies.

Chapter 5, Systems Interventions, targets health care administrators, 

insurers, and purchasers, and offers a blueprint to changes in health care 

delivery and coverage such that tobacco assessment and intervention 

become a standard of care in health care delivery.

Chapter 6, Evidence and Recommendations, presents the results of Guideline literature reviews and statistical analyses and the recommendations 
6

that emanate from them. Guideline analyses address topics such as the 

effectiveness of different counseling strategies and medications; the relation 

between treatment intensities and treatment success; whether screening for 

tobacco use in the clinic setting enhances tobacco user identification; and 

whether systems changes can increase provision of effective interventions, 

quit attempts, and actual cessation rates. The Guideline Panel also made 

specific recommendations regarding future research needs.

Chapter 7, Specific Populations and Other Topics, evaluates evidence on 

tobacco intervention strategies and effectiveness with specific populations 

(e.g., HIV-positive smokers; hospitalized smokers; lesbian/gay/bisexual/

transgender smokers; smokers with low SES/limited educational attainment; smokers with medical comorbidities; older smokers; smokers with 

psychiatric disorders, including substance use disorders; racial and ethnic 

minorities; women smokers; children and adolescents; light smokers; pregnant smokers; and noncigarette tobacco users). The Guideline Panel made 

specific recommendations for future research on topics relevant to these 

populations. This chapter also presents information and recommendations 

relevant to weight gain after smoking cessation, with specific recommendations regarding future research on this topic.

Findings and Recommendations

The key recommendations of the updated Guideline, Treating Tobacco Use 

and Dependence: 2008 Update, based on the literature review and expert 

Panel opinion, are as follows:

 Ten Key Guideline Recommendations

The overarching goal of these recommendations is that clinicians strongly 

recommend the use of effective tobacco dependence counseling and medication treatments to their patients who use tobacco, and that health care 

systems, insurers, and purchasers assist clinicians in making such effective 

treatments available.

1. Tobacco dependence is a chronic disease that often requires repeated 

intervention and multiple attempts to quit. Effective treatments exist, 

however, that can significantly increase rates of long-term abstinence.
7

2. It is essential that clinicians and health care delivery systems consistently 

identify and document tobacco use status and treat every tobacco user 

seen in a health care setting. 

3. Tobacco dependence treatments are effective across a broad range of 

populations. Clinicians should encourage every patient willing to make 

a quit attempt to use the counseling treatments and medications recommended in this Guideline. 

4. Brief tobacco dependence treatment is effective. Clinicians should offer 

every patient who uses tobacco at least the brief treatments shown to be 

effective in this Guideline.

5. Individual, group, and telephone counseling are effective, and their 

effectiveness increases with treatment intensity. Two components of 

counseling are especially effective, and clinicians should use these when 

counseling patients making a quit attempt:

•	 Practical counseling (problemsolving/skills training)

•	 Social support delivered as part of treatment

6. Numerous effective medications are available for tobacco dependence, 

and clinicians should encourage their use by all patients attempting to quit 

smoking—except when medically contraindicated or with specific populations for which there is insufficient evidence of effectiveness (i.e., pregnant 

women, smokeless tobacco users, light smokers, and adolescents). 

•	 Seven first-line medications (5 nicotine and 2 non-nicotine) reliably

increase long-term smoking abstinence rates:

– Bupropion SR

– Nicotine gum

– Nicotine inhaler

– Nicotine lozenge

– Nicotine nasal spray

– Nicotine patch

– Varenicline 
8

•	 Clinicians also should consider the use of certain combinations of

medications identified as effective in this Guideline.

7. Counseling and medication are effective when used by themselves 

for treating tobacco dependence. The combination of counseling and 

medication, however, is more effective than either alone. Thus, clinicians should encourage all individuals making a quit attempt to use 

both counseling and medication. 

8. Telephone quitline counseling is effective with diverse populations and 

has broad reach. Therefore, clinicians and health care delivery systems 

should both ensure patient access to quitlines and promote quitline use. 

9. If a tobacco user currently is unwilling to make a quit attempt, clinicians should use the motivational treatments shown in this Guideline 

to be effective in increasing future quit attempts. 

10. Tobacco dependence treatments are both clinically effective and highly 

cost-effective relative to interventions for other clinical disorders. Providing coverage for these treatments increases quit rates. Insurers and 

purchasers should ensure that all insurance plans include the counseling and medication identified as effective in this Guideline as covered 

benefits. 

Guideline Update: Advances

A comparison of the findings of the 2008 Guideline update with the 2000 

Guideline reveals the considerable progress made in tobacco research over 

the brief period separating these two works. Among many important differences between the two documents, the following deserve special note:

•	The updated Guideline has produced even stronger evidence that

counseling is an effective tobacco use treatment strategy. Of particular 

note are findings that counseling adds significantly to the effectiveness 

of tobacco cessation medications, quitline counseling is an effective 

intervention with a broad reach, and counseling increases abstinence 

among adolescent smokers.

•	The updated Guideline offers the clinician a greater number of effective medications than were identified in the previous Guideline. Seven 
9

different effective first-line smoking cessation medications are now 

approved by the FDA for treating tobacco use and dependence. In addition, multiple combinations of medications have been shown to be 

effective. Thus, the clinician and patient have many more medication 

options than in the past. The Guideline also now provides evidence 

regarding the effectiveness of medications relative to one another.

•	The updated Guideline contains new evidence that health care policies

significantly affect the likelihood that smokers will receive effective 

tobacco dependence treatment and successfully stop tobacco use. For 

instance, making tobacco dependence a benefit covered by insurance 

plans increases the likelihood that a tobacco user will receive treatment 

and quit successfully. 

Future Promise

The research reviewed for this 2008 Guideline update suggests a bright 

future for treating tobacco use and dependence. Since the first AHCPR 

Clinical Practice Guideline was published in 1996, encouraging progress 

has been made in tobacco dependence treatment. An expanding body of 

research has produced a marked increase in the number and types of effective treatments and has led to multiple new treatment delivery strategies. 

These new strategies are enhancing the delivery of tobacco interventions 

both inside and outside health care delivery systems. This means that an 

unprecedented number of smokers have access to an unprecedented number of effective treatments.

Although the data reviewed in this Guideline update are encouraging and 

portend even greater advances through future research, for many smokers, 

the progress has been an undelivered promissory note. Most smokers 

attempting to quit today still make unaided quit attempts,29-32 although 

the proportion using evidence-based treatments has increased since the 

publication of the 1996 AHCPR Guideline.33-35 Because of the prevalence 

of such unaided attempts (those that occur without evidence-based 

counseling or medication), many smokers have successfully quit through 

this approach.6,36 It is clear from the data presented in this Guideline, 

however, that smokers are significantly more likely to quit successfully if 

they use an evidence-based counseling or medication treatment than if 

they try to quit without such aids. Thus, a future challenge for the field 

is to ensure that smokers, clinicians, and health systems have accurate 
10

information on the effectiveness of clinical interventions for tobacco use, 

and that the 70 percent of smokers who visit a primary care setting each 

year have greater access to effective treatments. This is of vital public 

health importance because the costs of failure are so high. Relapse results 

in continuing lifetime exposure to tobacco, which leads to increased risk 

of death and disease. Additional progress must be made in educating 

clinicians and the public about the effectiveness of clinical treatments 

for tobacco dependence and in making such treatments available and 

attractive to smokers.

Continued progress is needed in the treatment of tobacco use and dependence. Treatments should be even more effective and available, new counseling strategies should be developed, and research should focus on the 

development of effective interventions and delivery strategies for populations that carry a disproportionate burden from tobacco (e.g., adolescents; 

pregnant smokers; American Indians and Alaska Natives; individuals with 

low SES/limited educational attainment; individuals with psychiatric disorders, including substance use disorders). The decrease in the prevalence 

of tobacco use in the United States during the past 40 years, however, has 

been a seminal public health achievement. Treatment of tobacco use and 

dependence has played an important role in realizing that outcome.
11

 Chapter 1 Overview and Methods

Introduction

Tobacco use has been cited as the chief avoidable cause of illness and death 

in our society and accounts for more than 435,000 deaths each year in 

the United States.37,38 Smoking is a known cause of multiple cancers, heart 

disease, stroke, complications of pregnancy, chronic obstructive pulmonary 

disease (COPD), and many other diseases.4

 In addition, recent research 

has documented the substantial health dangers of involuntary exposure to 

tobacco smoke.4 Despite these health dangers and the public’s awareness of 

those dangers, tobacco use remains surprisingly prevalent. Recent estimates are that about 21 percent of adult Americans smoke,3

 representing 

approximately 45 million current adult smokers.3,39 Moreover, tobacco use 

remains a pediatric disease.40-42 Each day, about 4,000 youth ages 12 to 17 

years smoke their first cigarette, and about 1,200 children and adolescents 

become daily cigarette smokers.43-44 As a result, new generations of Americans are at risk for the extraordinarily harmful consequences of tobacco use.

Tobacco use exacts a heavy cost to society as well as to individuals. Smoking-attributable health care expenditures are estimated at $96 billion per 

year in direct medical expenses and $97 billion in lost productivity.28 It 

has been estimated that the per pack additional cost of smoking to society 

is approximately $7.18 per pack,45 and the combined cost of each pack to 

society and the individual smoker and family is nearly $40.46 If all smokers 

covered by state Medicaid programs quit, the annual savings to Medicaid 

would be $9.7 billion after 5 years.47

Despite the tragic consequences of tobacco use, clinicians and health care 

systems often fail to treat it consistently and effectively. For instance, in 

1995, about the time of the release of the first clinical practice guideline, 

smoking status was identified in only about 65 percent of clinic visits, and 

smoking cessation counseling was provided in only 22 percent of smokers’ 

clinic visits.48,49 Moreover, treatment typically was offered only to patients 

already suffering from tobacco-related diseases.48 This pattern gradually began to improve as of 2005, with up to 90 percent of smokers reporting they 

had been asked about smoking status and more than 70 percent reporting 

having received some counseling to quit.23,50,51 However, the failure to assess 

and intervene consistently with all tobacco users continues despite sub-
Treating Tobacco Use and Dependence: 2008 Update

12

stantial evidence that even brief interventions can be effective among many 

different populations of smokers.52-58 Also, the use of effective medications 

is low. Among current smokers who attempted to stop for at least 

1 day in the past year, only 21.7 percent used cessation medication.33

This Guideline concludes that tobacco use presents a rare confluence of circumstances: (1) a highly significant health threat;4

 (2) a lack of consistent 

intervention by clinicians; and (3) the presence of effective interventions. 

This last point is buttressed by evidence that tobacco use interventions, if 

delivered in a timely and effective manner, can rapidly reduce the risk of 

suffering from smoking-related disease.6-13 Indeed, it is difficult to identify 

any other condition that presents such a mix of lethality, prevalence, and 

neglect, despite effective and readily available interventions. 

Significant barriers interfere with clinicians’ assessment and treatment of 

smokers. Many clinicians lack knowledge about how to identify smokers 

quickly and easily, which treatments are effective, how such treatments 

can be delivered, and the relative effectiveness of different treatments.59-62

Additionally, clinicians may fail to intervene because of inadequate clinic 

or institutional support for routine assessment and treatment of tobacco 

use48,60,63 and for other reasons such as time constraints, limited training in 

tobacco cessation interventions, a lack of insurance coverage for tobacco 

use treatment, or inadequate payment for treatment.64-67

Rationale for Guideline Development and 

Periodic Updates

In the early 1990s, the Agency for Healthcare Policy and Research 

([AHCPR] now the Agency for Healthcare Research and Quality [AHRQ]) 

convened an expert panel to develop the Smoking Cessation Clinical Practice Guideline (the “Guideline”), Number 18 in the AHCPR series of Clinical Practice Guidelines. The need for this Guideline was based on several 

factors, including tobacco use prevalence, related morbidity and mortality, 

the economic burden imposed by tobacco use, variation in clinical practice, availability of methods for improvement of care, and availability of 

data on which to base recommendations for care. More than 1 million copies of the 1996 Guideline and its affiliated products were disseminated. The 

original Guideline recommendations inspired changes in diverse health 

care settings such as managed care organizations and the Veterans Health 

Administration. The original Guideline also provided a framework for edu-
Overview and Methods

13

cating clinicians, administrators, and policymakers about the importance 

of tobacco dependence and its treatment. It stimulated discussions that addressed the development of tobacco dependence treatment programs at the 

Federal and State levels and by professional medical organizations.

Significant new research findings regarding tobacco use and its treatment 

led to the 2000 Guideline update, which was authored by the expert panel 

that developed the 1996 Guideline. The 2000 Guideline update was a product of the U. S. Public Health Service (PHS), sponsored by a consortium of 

private and public partners, including AHRQ; National Cancer Institute 

(NCI); National Heart, Lung, and Blood Institute (NHLBI); National Institute on Drug Abuse (NIDA); Centers for Disease Control and Prevention 

(CDC); Robert Wood Johnson Foundation (RWJF); and University of Wisconsin School of Medicine and Public Health Center for Tobacco Research 

and Intervention (UW-CTRI).

The 2000 Guideline, titled Treating Tobacco Use and Dependence, comprised specific evidence-based recommendations to guide clinicians, 

tobacco treatment specialists, insurers, purchasers, and health care administrators in their efforts to develop and implement clinical and institutional changes that support the reliable identification, assessment, and 

treatment of patients who use tobacco. This title underscores three truths 

about tobacco use.68 First, all tobacco products—not just cigarettes—exact 

devastating costs on the Nation’s health and welfare. Second, for most users, tobacco use results in true drug dependence, comparable to the dependence caused by opiates, amphetamines, and cocaine.69-72 Third, both 

chronic tobacco use and dependence warrant clinical intervention and, as 

with other chronic disorders, these interventions may need to be repeated 

over time.73,74

The 2000 Treating Tobacco Use and Dependence document was the most 

widely disseminated Guideline ever released by AHRQ, with more than 

5 million copies of the Guideline and related products distributed. Moreover, it has had an enormous influence on tobacco use treatment and 

policy worldwide, serving as the basis for Guidelines in Australia, Canada, 

Chile, Japan, Portugal, and Switzerland, among other countries. 

The continued expansion of new scientific findings on the effective treatment of tobacco use led to calls for the current update, Treating Tobacco 

Use and Dependence: 2008 Update. The 2008 update reviewed scientific 
Treating Tobacco Use and Dependence: 2008 Update

14

evidence from 1975 to 2007 on selected topics and in total reviewed more 

than 8,700 scientific publications. The result of this methodologically rigorous review is an updated set of recommendations on effective counseling 

and medication treatments and institutional policies that can guide clinicians, specialists, and health systems in intervening with tobacco users. 

Appendix D summarizes new recommendations and changes to the 2000 

Guideline.

The clinician audience for this Guideline update is all professionals who 

provide health care to tobacco users. This includes: physicians, nurses, physician assistants, medical assistants, dentists, hygienists, respiratory therapists, psychologists, mental health counselors, pharmacists, and others. The 

ultimate beneficiaries of the Guideline are tobacco users and their families.

Most tobacco users in the United States are cigarette smokers. As a result, 

the majority of clinician attention and research in the field has focused 

on the treatment and assessment of smoking. Clinicians, however, should 

intervene with all tobacco users, not just with those who smoke cigarettes. 

To foster a broad implementation of this Guideline update, every effort has 

been made to describe interventions so that they are relevant to all forms 

of tobacco use. In some sections of this Guideline, the term “smoker” is 

used instead of “tobacco user.” The use of the term “smoker” means that 

all relevant evidence for a recommendation arises from studies of cigarette 

smokers. Additional discussion of noncigarette forms of tobacco use is 

found in Chapter 7.

The 2008 Guideline update generally is consistent with the findings of the 

2000 Guideline (see Appendix D). It also is important to note that other 

Guidelines and analyses on the treatment of tobacco dependence have been 

published with essentially consistent findings, including those from the 

American Psychiatric Association,75,76 the American Medical Association,77

the American Dental Association,78 the American Nurses Association,79

the American College of Obstetricians and Gynecologists, the Institute of 

Medicine,80 the United Kingdom Guideline,81 and the Cochrane Collaboration (www.cochrane.org/index.htm). Finally, throughout the Guideline 

update, the terms “tobacco use treatment” and “tobacco dependence treatment” will be used interchangeably to emphasize the fact that both chronic 

use and dependence merit clinical intervention. 
Overview and Methods

15

Tobacco Dependence as a Chronic Disease

Tobacco dependence displays many features of a chronic disease. Only a 

minority of tobacco users achieve permanent abstinence in an initial quit 

attempt. The majority of users persist in tobacco use for many years and 

typically cycle through multiple periods of remission and relapse. A failure 

to appreciate the chronic nature of tobacco dependence may impede clinicians’ consistent assessment and treatment of the tobacco user over time.

Epidemiologic data suggest that more than 70 percent of the 45 million 

smokers in the United States today report that they want to quit, and approximately 44 percent report that they try to quit each year.3

 Unfortunately, most of these efforts are both unaided and unsuccessful. For example, 

among the 19 million adults who attempted to quit in 2005,39 only 

4 to 7 percent were likely successful.82,83 These statistics may discourage 

both smokers and clinicians. 

Modern approaches to treating tobacco use and dependence should reflect 

the chronicity of tobacco dependence. A chronic disease model recognizes 

the long-term nature of the disorder with an expectation that patients may 

have periods of relapse and remission. If tobacco dependence is recognized 

as a chronic disease, clinicians will better understand the relapsing nature 

of the condition and the requirement for ongoing, rather than just acute, 

care. The existence of numerous effective treatments gives the clinician and 

patient many options should repeated quit attempts be needed. 

A chronic disease model emphasizes for clinicians the importance of 

continued patient education, counseling, and advice over time. Although 

most clinicians are comfortable in counseling their patients about other 

chronic diseases such as diabetes, hypertension, or hyperlipidemia, many 

believe that they are less effective in providing counseling to patients who 

use tobacco.84,85 As with these other chronic disorders, clinicians should 

be encouraged to provide tobacco-dependent patients with brief advice, 

counseling, and appropriate medication. It is important for clinicians to 

know that assessing and treating tobacco use generally leads to greater 

patient satisfaction with health care.23,50,86-88 Moreover, policy changes (e.g., 

tax increases, smoke-free ordinances) often lead smokers to seek treatment 

for this chronic disease.
Treating Tobacco Use and Dependence: 2008 Update

16

In updating the Guideline, the Panel has presented evidence-based analytic findings in a format accessible and familiar to practicing clinicians. 

Although this should aid clinicians in the assessment and treatment of 

tobacco users, clinicians should remain cognizant that relapse is likely 

and that it reflects the chronic nature of dependence. Most smokers who 

ultimately quit smoking experience episodes of relapse on the way to success. Relapse should not discourage the clinician or the tobacco user from 

renewed quit attempts.

Coordination of Care: Institutionalizing the 

Treatment of Tobacco Dependence

Increasing evidence shows that the success of any tobacco dependence 

treatment strategy cannot be divorced from the health care system in 

which it is embedded. Data strongly indicate that the consistent and effective delivery of tobacco interventions requires coordinated interventions. 

Just as a clinician must intervene with his or her patient, so must the health 

care administrator, insurer, and purchaser ensure the provision of tobacco 

dependence treatment as an integral element of health care delivery. Health 

care purchasers and insurers should ensure that evidence-based tobacco 

dependence counseling and medications are a covered and available health 

insurance benefit for all enrollees and that enrollees are aware of such 

benefits. Health care administrators also should provide clinicians with the 

training and institutional support and systems to ensure consistent identification of and intervention with patients who use tobacco. Therefore, 

insurers, purchasers, and health care organizations should promote the 

utilization of covered treatments and assess usage and outcomes in performance measurement systems.89 Finally, increasing evidence shows that, 

for maximum public health benefit, access to effective treatments should 

be increased during and following the implementation of population-level 

tobacco control policies (i.e., tobacco tax increases and clean indoor air 

laws), which boost motivation and support for quitting efforts.90

Guideline Development Methodology

 Introduction

Panel recommendations are intended to provide clinicians with effective strategies for treating patients who use tobacco. Fundamentally, this 

document is a clinical practice guideline. Recommendations were influ-
Overview and Methods

17

enced by two goals. The first was to identify effective treatment strategies. 

The second was to formulate and present recommendations that can be 

implemented easily across diverse clinical settings (e.g., primary care and 

specialty clinics; pharmacies; hospitals, including emergency departments; 

worksites; and school-based clinics) and patient populations. 

The Guideline update is based on three systematic reviews of the available scientific literature. The first review occurred during the creation of 

the original Guideline published in 1996 and included literature published 

from 1975 through 1994. The second review was conducted for the 2000 

Guideline and included literature from 1995 through January 1999. The 

third review was conducted on literature published from 1999 to June 

2007. The three data sets were combined into a single database that was 

used for the 2008 analyses.

The Panel identified randomized placebo/comparison controlled trials as 

the strongest level of evidence for the evaluation of treatment effectiveness. 

Thus, evidence derived from randomized controlled trials serves as the basis for meta-analyses and for almost all of the recommendations contained 

in this Guideline. Questions have been raised about medication placebo 

controls because individuals sometimes guess their actual medication 

condition at greater than chance levels.91 It is possible, therefore, that the 

typical randomized control trial does not control completely for placebo 

effects. This should be borne in mind when appraising the results of the 

medication meta-analyses. Further, in studies of counseling, it often is not 

possible to control for a nonspecific placebo effect. 

The Panel occasionally made recommendations in the absence of randomized controlled trials when faced with an important clinical practice issue 

for which other types of evidence existed. This Guideline clearly identifies the level or strength of evidence that serves as the basis for each of its 

recommendations.

 Topics Included in the Guideline

The Panel identified tobacco use as the targeted behavior and tobacco users as the clinical population of interest. Tobacco dependence treatments 

were evaluated for effectiveness, as were interventions aimed at modifying both clinician and health care delivery system behavior. At the start of 

the 2008 update process, Guideline Panel members, outside experts, and 
Treating Tobacco Use and Dependence: 2008 Update

18

consortium representatives were consulted to determine those aspects of 

the 2000 Guideline that required updating. These consultations resulted in 

the following chief recommendations that guided the update efforts: (1) to 

conduct new literature reviews and meta-analyses on topics distinguished 

by their public health importance and for which significant new evidence 

is available; (2) to review previous recommendations and to identify a 

subset of recommendations for which to review new data; special attention 

was paid to clinical situations for which the Panel had previously achieved 

consensus in the absence of relevant controlled trials (“C”-level recommendations) to ensure that these still warranted Guideline Panel support; 

(3) to consider anew the strategies that might be used in clinical settings to 

deliver brief tobacco dependence interventions (see Chapter 3); and (4) to 

identify important topics for future research. Eleven topics out of 64 considered were chosen by the Panel for updated meta-analysis (see Table 1.1).

Table 1.1. Topics chosen by the 2008 Guideline Panel for updated meta-analysis

Effectiveness of proactive quitlines

Effectiveness of combining counseling and medication relative to either counseling or 

medication alone

Effectiveness of varenicline

Effectiveness of various medication combinations

Effectiveness of long-term medication use

Effectiveness of tobacco use interventions for individuals with low SES/limited formal 

education 

Effectiveness of tobacco use interventions for adolescent smokers

Effectiveness of tobacco use interventions for pregnant smokers

Effectiveness of tobacco use interventions for individuals with psychiatric disorders, 

including substance use disorders

Effectiveness of providing tobacco use interventions as a health benefit

Effectiveness of systems interventions, including provider training and the combination of training and systems interventions

This Guideline update was specifically intended to review the evidence 

regarding clinical treatment of tobacco dependence. Interventions for the 

primary prevention of tobacco use were not examined in detail, with the 

exception of interventions directly relevant to clinical practice. Readers 

also may refer to the 1994 Surgeon General’s Report, Preventing Tobacco 

Use Among Young People41 and the 2000 Surgeon General’s Report, Reducing Tobacco Use,6

 for information on the primary prevention of tobacco 
Overview and Methods

19

use. Community-level interventions (e.g., mass media campaigns) that 

are not usually implemented in primary care practice settings were not 

addressed. For more information on community-based tobacco use prevention, refer to the Centers for Disease Control and Prevention Guide to 

Community Preventive Services.92 The Guideline update did not examine 

evidence regarding unaided quit attempts as this Guideline focused on 

clinical interventions. Finally, the use of exposure reduction strategies93

(strategies in which tobacco users alter, rather than eliminate, their use of 

nicotine or tobacco in an attempt to reduce or avoid its harmful consequences) were not considered due to a lack of data and the fact that they 

are beyond the scope of a clinical practice guideline focused on treating tobacco use and dependence. Current research does not offer answers to key 

questions regarding exposure reduction strategies: their population-wide 

impact on cessation and initiation of smoking, their long-term benefits as 

compared with those of a strategy focused on tobacco abstinence, and their 

success in reducing long-term exposure to tobacco toxins. 

This Guideline update is designed for two main audiences: first, clinicians; 

and second, health care administrators, insurers, and purchasers. It is 

designed to be used in a wide variety of clinical practice settings, including private medical practices; dental offices; pharmacies; academic health 

centers; mental health and substance abuse treatment clinics; telephone 

quitlines; managed care organizations; public health department clinics; 

hospitals, including emergency departments; and school or worksite clinics. The ultimate beneficiaries of the Guideline are tobacco users and their 

families.

 Guideline Development Process

The 2008 Guideline update development process (see Figure 1.1) was initiated in mid-2006. The methodology was consistent with that followed by 

the 2000 Guideline except where specifically identified below.

 Selection of Evidence

Published, peer-reviewed, randomized controlled studies were considered 

to constitute the strongest level of evidence in support of Guideline recommendations. This decision was based on the judgment that randomized 

controlled trials provide the clearest scientifically sound basis for judging 
Treating Tobacco Use and Dependence: 2008 Update

20

Figure 1.1. 2008 Guideline development process

Topics for the update solicited from Panel and the public

Literature searches conducted by topic

Abstracts obtained

Abstracts reviewed for inclusion/exclusion criteria by literature reviewers

Update topics chosen by Panel

Full copy of each accepted article read and independently

coded by at least 3 literature reviewers

Evidence tables created by literature reviewers

Initial meta-analyses conducted

Panel reviewed relevant literature and meta-analytic results

Panel formed tentative conclusions, identified need for further analyses

Additional literature reviews and meta-analyses conducted

Panel reviewed updated evidence and made recommendations based on evidence

Manuscript drafted and reviewed by Panel

Additional manuscript drafts reviewed by Panel

Manuscript draft reviewed by peer reviewers and the public

Manuscript revised and reviewed by Panel

Manuscript submitted to PHS
Overview and Methods

21

comparative effectiveness. Most of these randomized trials, however, were 

conducted with individuals who proactively sought treatment and who 

volunteered to fulfill various research requirements. It is possible that these 

individuals were more highly motivated to quit smoking than the typical smoker encountered in a clinical practice setting. Thus, the percentage 

abstinent estimates supplied with the meta-analyses may overestimate the 

actual level of abstinence produced by some of the treatments in real-world 

settings. Analyses conducted for the previous Guideline editions, though, 

suggest that the treatment effect sizes (odds ratios or ORs) are relatively 

stable across individuals seeking treatment (“treatment seekers”) and those 

recruited via inclusive recruitment strategies (“all-comers”). Randomized controlled trials were exclusively used in meta-analyses. However, 

the Panel recognized that variations in study inclusion criteria sometimes 

were warranted. For instance, research on tobacco interventions in adolescents frequently assigns interventions on the basis of larger units, such as 

schools. These units, rather than individuals, were allowed to serve as units 

of analysis when analyzing interventions for adolescents. In such cases, 

studies were combined for inclusion in meta-analyses if the study satisfied other review criteria. A similar strategy was followed in the review of 

health systems research. 

In certain areas, research other than randomized clinical trials was evaluated and considered to inform Panel opinion and judgment, though not 

submitted to meta-analysis. This occurred with topics such as tobacco 

dependence treatment in specific populations, tailoring interventions, and 

cost-effectiveness of tobacco dependence treatment.

 Literature Review and Inclusion Criteria

Approximately 8,700 articles were screened to identify evaluable literature. 

This figure includes approximately 2,700 articles added to the literature 

since publication of the 2000 Guideline. These articles were obtained 

through searches of 11 electronic databases and reviews of published 

abstracts and bibliographies. An article was deemed appropriate for 

meta-analysis if it met the criteria for inclusion established a priori by 

the Panel. These criteria were that the article: (a) reported the results 

of a randomized, placebo/comparison controlled trial of a tobacco use 

treatment intervention randomized on the patient level (except as noted 

above); (b) provided followup results at least 5 months after the quit date 

(except in the case of studies evaluating tobacco dependence treatments 
Treating Tobacco Use and Dependence: 2008 Update

22

for pregnant smokers); (c) was published in a peer-reviewed journal; (d) 

was published between January 1975 and June 2007; (e) was published in 

English; and (f) was one of the 11 topics chosen to be included in the 2008 

update (see Table 1.1). It is important to note that the article-screening 

criteria were updated for the 2008 Guideline update. Additionally, articles 

were screened for relevance to safety, economic, or health systems issues. 

As a result of the original and update literature reviews, more than 300 

articles were identified for possible inclusion in a meta-analysis, and more 

than 600 additional articles were examined in detail by the Panel. These 

latter articles were used in the formulation of Panel recommendations that 

were not supported by meta-analyses. The literature search for the update 

project was validated by comparing the results against a search conducted 

by the CDC and through review by the expert Panel. 

When individual authors published multiple articles meeting the metaanalytic inclusion criteria, the articles were screened to determine whether 

they contained unique data. When two articles reported data from the 

same group of subjects, both articles were reviewed to ensure that complete 

data were obtained. The data were treated as arising from a single study in 

meta-analyses.

 Preparation of Evidence Tables

Two Guideline staff reviewers independently read and coded each article 

that met inclusion criteria. The reviewers coded the treatment characteristics that were used in data analyses (see Tables 6.1 and 6.2 in Chapter 6). 

The same general coding procedure employed during the 2000 Guideline 

process was employed during the update. When adjustments to the coding 

process were made, articles coded with the original process were re-coded 

to reflect the changed coding (e.g., more refined coding criteria were used 

for the coding of treatment intensity). 

A third reviewer then examined the coding of both reviewers and adjudicated any differences. Discrepancies that could not be resolved through 

this process were adjudicated by the project manager, Panel chair, and/or 

the Panel’s senior scientist. Finally, each article accepted for a meta-analysis 

had key fields reviewed by the project manager as a final quality check. The 

data then were compiled and used in relevant analyses and/or Panel deliberations. Analyses done for the 2000 Guideline revealed that intervention 

coding categories could be used reliably by independent raters.94
Overview and Methods

23

 Outcome Data

Six-month followup after the quit date is a standard followup duration 

for reporting data from clinical trials. Therefore, focusing on a 6-month 

timepoint in meta-analyses allowed the investigators to capture the greatest 

number of studies for analysis. Also, research indicates that a high percentage of those who ultimately return to smoking will do so by 6 months.95-98

Because a strict adherence to a 6-month timepoint would have eliminated 

a significant number of studies, a 1-month window was permitted such 

that studies with 5 months of followup data were included, but 6-month 

data were used if both 5- and 6-month data were available. When quit rates 

were provided for longer endpoints, outcome data from the endpoint closest to 6 months were used, so long as they did not exceed 3 years. Outcome 

data beyond 3 years rarely were available and were not included in the 

Guideline analyses. In the area of medication treatment, the inclusive meta-analysis reported in Table 6.26 was repeated with longer term outcome 

data (10–14 month postquit). This additional meta-analysis largely replicated the results of the meta-analysis based on a 6-month followup time 

frame. This suggested that the shorter, more inclusive, followup timepoint 

captured effect sizes that were similar to those yielded by the use of longer 

followup timepoints. There was one exception to the selection of followup 

data described above. In the case of pregnancy studies, both predelivery 

and postdelivery (5 months) outcomes were analyzed.

Panel staff also coded biochemical confirmation of self-reported tobacco 

use abstinence. Previous Guideline analyses show that studies with and 

without biochemical confirmation yield similar meta-analysis results. 

Therefore, meta-analyses presented in the Guideline reflect a pooling of 

these studies. If both biochemically confirmed and nonconfirmed data 

were available from the same study, however, the confirmed data were used 

in analyses. As in the 2000 Guideline, only studies that used biochemical 

verification were used in the meta-analyses of pregnant smokers because of 

the under-reporting of smoking status by pregnant women. 

All of the new meta-analyses conducted for the 2008 Guideline were based 

exclusively on intent-to-treat data, in which the denominator was the 

number of participants randomized to treatment and the numerator was 

the number of abstinent participants contacted at followup. Some metaanalyses conducted for the 1996 and 2000 Guideline comprised a small 

number of studies in which the denominator consisted only of participants 
Treating Tobacco Use and Dependence: 2008 Update

24

who completed treatment. The vast majority of studies across all analyses 

reported intent-to-treat data and these data were used if both types of data 

were available. 

Studies were coded for how the outcome measures were reported—“point 

prevalence,” “continuous,” or “unknown/other.” If abstinence data were 

based on tobacco use occurrence within a set time period (usually 7 days) 

prior to a followup assessment, the outcome measure was coded as “point 

prevalence.” “Continuous” was used when a study reported abstinence 

based on whether study subjects were continuously abstinent from tobacco use since their quit day. “Unknown/other” was used when it was 

not possible to discern from the study report whether the authors used a 

point prevalence or continuous measure for abstinence or if abstinence was 

measured from some point other than the quit day. 

As in the 1996 and 2000 Guidelines, a point prevalence outcome measure (7-day point prevalence, when available), rather than continuous 

abstinence, was used as the chief outcome variable. Point prevalence was 

preferred for several reasons. First, this was the modal reporting method 

among the analyzable studies. Second, continuous abstinence data may 

underestimate the percentage of individuals who are abstinent at particular followup timepoints, although some data suggest that these rates 

are similar.99 Finally, most relapse begins early in a quit attempt and persists.95-97,100-102 A point prevalence measure taken at 6 months certainly 

would capture the great majority of those relapse events. Therefore, whenever possible, 7-day point prevalence abstinence data were used. If point 

prevalence data were not available, the preferred alternative was continuous abstinence data.

 Meta-Analytic Techniques

The principal analytic technique used in this Guideline update was metaanalysis. This statistical technique estimates the impact of a treatment or 

variable across a set of related investigations. The primary meta-analytic 

model used in this and the previous two Guidelines was logistic regression 

using random effects modeling. The modeling was performed at the level 

of the treatment arm, and study effects were treated as fixed. The panel 

methodologist chose to employ random effects modeling, assuming that 

both the subject populations and the treatment elements analyzed would 
Overview and Methods

25

vary from study to study (e.g., counseling might be done somewhat differently at two different sites). Random effects modeling is well suited to 

accommodate such variation among studies.103 The statistician used the 

EGRET Logistic Normal Model.104 A complete and detailed review of the 

meta-analytic methods used in the Guideline can be found in the Smoking Cessation Guideline Technical Report No. 18, available from AHRQ as 

AHCPR Publication No. 97-N004. The specific articles used in each metaanalysis included in the 2008 Guideline can be found at www.surgeon

general.gov/tobacco/gdlnrefs.htm.

In general, meta-analysis was used only with studies with randomization 

at the level of subject. In some areas (health systems changes, adolescents), 

however, studies often involved randomization at another level (e.g., 

clinician, clinic, etc.). Such studies were used in meta-analyses of a small 

number of topics when such studies occurred in sufficient numbers to permit inferences. Screening of such articles considered factors such as data 

nonindependence, the evaluation of pre-intervention or baseline status, 

and the number and types of higher level units. 

The initial step in meta-analysis was the selection of studies that were relevant to the treatment characteristic being evaluated. After relevant studies 

were identified (i.e., those that contained a self-help intervention if self-help 

treatments were being evaluated), Panel staff reviewed the studies to ensure 

that they passed screening criteria. Some screening criteria were general 

(e.g., study presents greater than 5 months of followup data), whereas other 

criteria were specific to the type of treatment characteristic evaluated 

(i.e., in the analysis of quit lines, screening ensured that treatment arms 

were not confounded with differing intensities of in-person counseling). 

The separate arms (treatment or control groups) in each study then were 

inspected to identify confounders that could compromise interpretation. 

Seriously confounded arms were excluded from analysis. Relevant characteristics of each arm were then coded to produce meaningful analytic comparisons. Criteria for performing a meta-analysis included: (1) the Guideline Panel judged the topic to be addressed in the meta-analysis as having 

substantial clinical significance; (2) at least two studies meeting selection 

criteria existed on the topic and the studies contained suitable within-study 

control or comparison conditions (e.g., each study had to contribute at 

least two arms that would permit the estimation of within-study effects); 

and (3) there was an acceptable level of interstudy homogeneity in the 
Treating Tobacco Use and Dependence: 2008 Update

26

analyzed variable or treatment so as to permit meaningful inference (e.g., 

an analyzed treatment was sufficiently similar across various studies so that 

combining studies was meaningful).

Limitations of Meta-Analytic Techniques. Several factors can compromise 

the internal validity of meta-analyses. For example, publication biases (particularly the tendency to publish only those studies with positive findings) 

may result in biased summary statistics. The complement to publication 

bias is the “file-drawer effect,” in which negative or neutral findings are not 

submitted for publication. In addition, either the magnitude or the significance of the effects of meta-analyses may be influenced by factors such as 

the frequency with which treatments occurred in the data set and by the 

extent to which treatments co-occurred with other treatments. All else being equal, a treatment that occurs infrequently in the data set is less likely 

to be found significant than a more frequently occurring treatment. Also, 

when two treatments co-occur frequently in the same groups of subjects, it 

is difficult to apportion statistically the impact of each. In addition, comparability biases can exist when substantially different groups or treatments 

are coded as being the same (e.g., when treatments are similar only on a 

superficial attribute).

The generalizability of meta-analytic findings was evaluated for previous Guideline editions with respect to whether patients sought cessation 

treatment (“self-selected”) or whether treatment was delivered without the 

patient seeking it (“all-comers,” as when cessation treatment occurred as an 

integral part of health care). Conducting separate meta-analyses in these 

different subject populations yielded very similar findings across a variety 

of treatment dimensions (e.g., treatment format, treatment intensity). No 

other population characteristic (e.g., years smoked, severity of dependence) 

was explored in meta-analyses.

Interpretation of Meta-Analysis Results. The meta-analyses yielded logistic 

regression coefficients that were converted to odds ratios. The meaning 

or interpretation of an odds ratio can be seen most easily by means of an 

example depicted in a 2 x 2 table. Table 1.2 contains data showing the relation between maternal smoking and low birth-weight in infants. Data are 

extracted from Hosmer and Lemeshow, 2000.105 The odds of a low birthweight infant if the mother smokes are 30:44, or 0.68 to 1. The odds of a 

low birth-weight infant if the mother does not smoke are 29:86, or 0.34 to 

1. The odds ratio may be estimated as (30/44)/(29/86) = 2.02 to 1. There-
Overview and Methods

27

fore, the odds ratio can be seen roughly as the odds of an outcome on one 

variable, given a certain status on another variable(s). In the case above, the 

odds of a low birth-weight infant are about double for women who smoke 

compared with those who do not.

Table 1.2. Relation between maternal smoking and low birth-weight in infants 

Maternal smoking

Yes No

Low birthweight

Yes 30 29 59

No 44 86 130

74 115 189

Once odds ratios were obtained from the meta-analyses, 95 percent confidence intervals (C.I.) were estimated around the odds ratios. An odds ratio 

is only an estimate of a relation between variables. The 95 percent confidence interval presents an estimate of the precision of the particular odds 

ratio obtained. If the 95 percent confidence interval for a given odds ratio 

does not include “1,” then the odds ratio represents a statistically significant 

difference between the evaluated treatment and the reference or control 

condition at the 0.05 level. The confidence intervals generally will not be 

perfectly symmetrical around an odds ratio because of the distributional 

properties of the odds ratio. The confidence intervals do not reveal whether 

active treatments differ significantly from one another, only whether they 

differ from the comparison condition (e.g., placebo medication, no contact). In the inclusive meta-analysis on medications, comparisons of an 

active medication versus the nicotine patch were accomplished via a posteriori contrasts, not on the basis of nonoverlapping confidence intervals.

After computing the odds ratios and their confidence intervals, the odds 

ratios were converted to abstinence percentages and their 95 percent confidence intervals (based on reference category abstinence rates). Abstinence 

percentages indicate the estimated long-term abstinence rate achieved 

under the tested treatment or treatment characteristic. The abstinence 

percentage results are approximate estimates derived from the odds ratio 

data. Therefore, they essentially duplicate the odds ratio results but are 

presented because their meaning may be clearer for some readers. Because 

the placebo/control abstinence percentage for a particular analysis is calculated exclusively from the studies included within that meta-analysis, these 

abstinence percentages vary across the different analyses. Therefore, the 
Treating Tobacco Use and Dependence: 2008 Update

28

odds ratios and abstinence rates presented across the different tables are 

estimated relative to different placebo or control conditions.

 How To Read the Data Tables

Table 1.3 depicts results from one of the meta-analyses reported in this 

Guideline update. This table presents results from the analysis of the effects 

of proactive telephone counseling (see Formats of Psychosocial Treatments 

in Chapter 6). In this table, the comparison condition, or “reference group,” 

for determining the impact of different treatment options was smokers who received minimal or no counseling or self-help. The “Estimated 

odds ratio” column reveals that treatment conditions receiving proactive 

telephone counseling had an odds ratio of 1.6. The odds ratio indicates a 

statistically significant effect because the lower boundary of the confidence 

interval did not include “1.” This odds ratio means that when smokers receive proactive telephone counseling, they are more than one and one-half 

times more likely to remain abstinent than if they had received minimal or 

no counseling or self-help.

Table 1.3. Meta-analysis (2008): Effectiveness of and estimated abstinence rates 

for proactive telephone counseling compared to minimal interventions, self-help, 

or no counseling (n = 9 studies)

Intervention

Number of

arms

Estimated

odds ratio

(95% C.I.)

Estimated

abstinence rate

(95% C.I.)

Minimal or no counseling 

or self-help 11 1.0 10.5

Quitline counseling 11 1.6 (1.4–1.8) 15.5 (13.8–17.3)

The column labeled “Estimated abstinence rate” shows the abstinence 

percentages for the two treatment conditions. For instance, the reference 

condition (minimal or no counseling) in the analyzed data set was associated with an abstinence rate of 10.5 percent. Consistent with the odds ratio 

data reviewed above, proactive telephone counseling produced modest 

increases in abstinence rates (15.5%). 

The total number of studies included in each meta-analysis is provided 

within the title of the corresponding table. A list of published articles used 

in each meta-analysis can be found at: www.surgeongeneral.gov/tobacco/

gdlnrefs.htm. Finally, the 2008 Guideline update includes meta-analyses 
Overview and Methods

29

completed for the 1996, 2000, and 2008 Guidelines. In the title of each 

meta-analysis, the year in which it was first published is provided.

The column labeled “Number of arms” specifies the number of treatment 

groups across all analyzed studies that contributed data to the various 

treatment conditions (e.g., Quitline counseling was provided in 11 treatment arms). Therefore, this column depicts the number of treatment 

groups relevant to each analyzed category. Because a study may have 

multiple treatment groups, the number of treatment arms may exceed the 

number of studies included in a meta-analysis.

The outcome data in the tables may include findings from both studies 

with “all-comers” (individuals who did not seek a treatment intervention) 

and “self-selected” populations, studies using point-prevalence and continuous abstinence endpoints, and studies with and without biochemical confirmation, except where otherwise described. Some meta-analyses (such as 

those evaluating medications) included predominantly studies with “selfselected” populations who volunteered for intensive treatment. In addition, 

in medication studies, both experimental and control subjects typically 

received substantial counseling. Both of these factors might have produced 

higher abstinence rates in reference or placebo subjects than typically are 

observed among self-quitters. Finally, although there is an important scientific distinction between “efficacy” and “effectiveness,”106 this 2008 clinical 

update uses the term “effectiveness” exclusively, recognizing that the majority of the studies summarized here reflect efficacy research, which requires 

random assignment and a high degree of experimental control. This was 

done for purposes of clarity for the intended clinical audience. 

 Strength of Evidence

Every recommendation made by the Panel bears a strength-of-evidence 

rating that indicates the quality and quantity of empirical support for the 

recommendation. Each recommendation and its strength of evidence reflects consensus of the Guideline Panel. 

The three strength-of-evidence ratings are described below:

A. Multiple well-designed randomized clinical trials, directly relevant to 

the recommendation, yielded a consistent pattern of findings.
Treating Tobacco Use and Dependence: 2008 Update

30

B. Some evidence from randomized clinical trials supported the recommendation, but the scientific support was not optimal. For instance, few 

randomized trials existed, the trials that did exist were somewhat inconsistent, or the trials were not directly relevant to the recommendation.

C. Reserved for important clinical situations in which the Panel achieved 

consensus on the recommendation in the absence of relevant randomized controlled trials.

As noted previously, the Panel evaluated evidence from nonrandomized 

trials to inform members’ understanding of certain topics (e.g., policy 

issues). If treatment recommendations were based primarily on such 

evidence, they were of the “C” level and depended on the consistency of 

findings across different studies. In some areas, the highest quality evidence does not depend on randomized trials (e.g., cost-effectiveness). In 

these areas, the strength-of-evidence rating depended on the number, quality, and consistency of the studies and evidence. Finally, the Panel declined 

to make recommendations when there was no relevant evidence or the 

evidence was too weak or inconsistent to support a recommendation.

 Caveats Regarding Recommendations

The reader should note some caveats regarding Guideline recommendations. First, an absence of studies should not be confused with a proven 

lack of effectiveness. In certain situations, there was little direct evidence 

regarding the effectiveness of some treatments, and in these cases the Panel 

usually rendered no opinion. Second, even when there were enough studies 

to perform a meta-analysis, a nonsignificant result does not prove ineffectiveness. Rather, nonsignificance merely indicates that effectiveness was not 

demonstrated given the data available.

The primary emphasis of this Guideline update is to identify effective 

interventions, not to rank-order interventions in terms of effectiveness. 

The most important goal of the analytic process is to identify effective 

interventions. Selection or use of particular intervention techniques or 

strategies usually is a function of practical factors: patient preference, 

time available, training of the clinician, cost, and so on. The Panel believes 

clinicians should choose the most appropriate intervention from among 
Overview and Methods

31

the effective interventions identified in this Guideline update, given 

clinical circumstances. An excessive emphasis on relative effectiveness 

might discourage clinicians from using interventions that have a small 

but reliable impact on quit rates. One meta-analysis that is new to this 

update does provide focused tests of the relative effectiveness of different 

interventions. Specifically, the inclusive meta-analysis of the tobacco 

use medications involved a posteriori tests of medication effectiveness 

versus the nicotine patch (Table 6.28). These tests of relative effectiveness 

were conducted on this topic because: (1) numerous treatments were 

available for comparison; (2) selection from among the various tobacco 

use medications has been noted as an important clinical concern;107-109

and (3) the various interventions are somewhat interchangeable and 

widely available so that the clinician or patient might be able to select a 

medication based on effectiveness. Finally, the panel occasionally identified 

an intervention as superior to another in the absence of formal statistical 

contrasts; some interventions were so superior to control or no-treatment 

conditions that the Panel clearly identified them as superior to another 

intervention. For instance, although minimal person-to-person contact can 

increase smoking abstinence rates over no-treatment conditions, there is 

little doubt that longer person-to-person interventions have greater impact 

(see Chapter 6).

 External Review of the Guideline

For the present update, the Panel and consortium members invited 106 

reviewers to make comments. In addition, a draft of the Guideline was 

published in the Federal Register in September 2007 for public comment. A 

total of 81 invited reviewers and 15 members of the public supplied written 

comments. Peer reviewers included clinicians, health care administrators, 

social workers, counselors, health educators, researchers, consumers, key 

personnel at selected Federal agencies and State tobacco control programs, 

and others. All peer reviewers made financial disclosure statements, which 

were provided to the Panel. Reviewers were asked to evaluate the Guideline 

based on five criteria: validity, reliability, clarity, clinical applicability, and 

utility. Comments from the peer reviewers and public were incorporated 

into the Guideline when appropriate. Two individuals made oral presentations to the Guideline Panel during an advertised open presentation 

period.
Treating Tobacco Use and Dependence: 2008 Update

32

Organization of the Guideline Update

This updated Guideline is divided into seven chapters that reflect the major 

components of tobacco dependence treatment (see Figure 1.2 for the treatment model): 

Chapter 1, Overview and Methods, provides an overview and rationale for 

the updated Guideline, as well as a detailed description of the methodology used to review the scientific literature and develop the original and 

updated Guidelines.

Chapter 2, Assessment of Tobacco Use, establishes the importance of determining the tobacco use status of every patient at every visit. 

Chapter 3, Clinical Interventions for Tobacco Use and Dependence, is 

intended to provide clinicians with guidance as they use brief interventions 

to treat tobacco users willing to quit, tobacco users unwilling to make a 

quit attempt at this time, and tobacco users who have recently quit.

A. For the Patient Willing To Quit, provides brief clinical approaches to 

assist patients in quit attempts. 

B. For the Patient Unwilling To Quit, provides brief clinical approaches 

designed to motivate the patient to make a quit attempt. 

C. For the Patient Who Has Recently Quit, provides clinicians with 

strategies designed to reinforce a former tobacco user’s commitment 

to stay tobacco-free and assist patients who have relapsed.

Chapter 4, Intensive Interventions for Tobacco Use and Dependence, provides clinicians with more intensive strategies to treat tobacco users.

Chapter 5, Systems Interventions, targets health care administrators, insurers, purchasers, and other decisionmakers who can affect health care systems. This chapter provides these decisionmakers with strategies to modify 

health care systems to improve the delivery of tobacco treatment services.

Chapter 6, Evidence and Recommendations, presents the evidentiary basis 

for the updated Guideline recommendations. 
Overview and Methods

33

A. Counseling and Psychosocial Evidence: Provides recommendations 

and analysis results regarding screening for tobacco use and specialized assessment, advice, intensity of clinical interventions, type 

of clinician, format, followup procedures, types of counseling and 

behavioral therapies, and the combination of counseling and medication. 

B. Medication Evidence: Provides recommendations and analysis results regarding the seven first-line medications, combination medications, second-line medications, and other medication issues.

C. Systems Evidence: Provides recommendations and analysis results 

regarding systems changes, including provider training, cost-effectiveness, and health insurance coverage for tobacco use treatments.

Chapter 7, Specific Populations and Other Topics, provides information on 

specific populations, including HIV-positive smokers; hospitalized smokers; lesbian/gay/bisexual/transgender smokers; smokers with low SES/limited formal education; smokers with medical comorbidities; older smokers; 

smokers with psychiatric disorders, including substance use disorders; 

racial and ethnic minorities; women smokers; children and adolescents; 

light smokers; and noncigarette tobacco users. This chapter also presents 

information and recommendations relevant to weight gain after quitting 

smoking, with specific recommendations regarding future research on this 

topic.

 References

Given the volume of literature referenced in this Guideline, references are 

listed at www.surgeongeneral.gov/tobacco/gdlnrefs.htm, rather than in this 

document. This was done to manage the length of this Clinical Guideline 

update and to facilitate electronic searches and manipulation of the references. Within this Web site, text references are numbered to match the 

numbers in this Guideline update. References to randomized control trials 

used in all of the meta-analyses (1996, 2000, 2008) are listed separately and 

by table number and title. The entire Guideline update, with and without 

references, can be downloaded from the site.
Treating Tobacco Use and Dependence: 2008 Update

34Figure 1.2. Model for treatment of tobacco use and dependence

General

population

Patient presents to a health care setting (clinic, hospital, work site, others)

Ask – screen all

patients for tobacco use 

Chapter 2

Primary

prevention

Prevent 

relapse

Chapter 3C

Former

users

No

Yes

Patient remains unwilling

Patient now

willing to quit

Current

Users

Advise to

Quit

Chapter 3A

Assess

willingness to quit 

Chapter 3A

Promote

motivation

to quit

Chapter 3B

Arrange followup

Chapter 3A

Abstinent

Relapse

Assist with

quitting

Chapter 3A Chapter 4

Never

uses
35

 Chapter 2 Assessment of Tobacco Use

At least 70 percent of smokers see a physician each year, and almost onethird see a dentist.19,110 Other smokers see physician assistants, nurse 

practitioners, nurses, physical and occupational therapists, pharmacists, 

counselors, and other clinicians. Therefore, virtually all clinicians are in a 

position to intervene with patients who use tobacco. Moreover, 70 percent 

of smokers report wanting to quit,111 and almost two-thirds of smokers 

who relapse want to try quitting again within 30 days.112 Finally, smokers 

cite a physician’s advice to quit as an important motivator for attempting to 

stop smoking.113-118 These data suggest that most smokers are interested in 

quitting, clinicians and health systems are in frequent contact with smokers, and clinicians have high credibility with smokers. 

Unfortunately, clinicians and health systems do not capitalize on this opportunity consistently. According to the National Committee for Quality 

Assurance’s (NCQA) State of Health Care Quality Report,

119 there has been 

some improvement in tobacco dependence clinical intervention for the 

insured population. In 2005, 71.2 percent of commercially insured smokers 

received cessation advice (up slightly from 69.6% in 2004); and 75.5 percent 

of Medicare smokers received advice to quit, up 11 percentage points from 

2004 for this group. Despite this progress, there is a clear need for additional 

improvement. Only 25 percent of Medicaid patients reported any practical 

assistance with quitting or any ensuing followup of their progress.22 Only 

one-third of adolescents who visited a physician or dentist report receiving 

counseling about the dangers of tobacco use, according to the 2000 National 

Youth Tobacco Survey.120 Pregnant women who smoke were identified at 

81 percent of physician visits but received counseling at only 23 percent 

of these visits.121 In addition, few smokers get specific help with quitting. 

Recent Healthcare Effectiveness Data and Information Set (HEDIS) data 

showed that only 39 percent of smokers reported that their clinician discussed either medications or counseling strategies to quit (www.web.ncqa.

org/tabid/59/Default.aspx). To capitalize on this opportunity, the 2008 

Guideline update provides empirically validated tobacco treatment strategies designed to spur clinicians, tobacco treatment specialists, and health 

systems to intervene effectively with patients who use tobacco.

The first step in treating tobacco use and dependence is to identify tobacco 

users. As the data analysis in Chapter 6 shows, the identification of smok-
Treating Tobacco Use and Dependence: 2008 Update

36

ers itself increases rates of clinician intervention. Effective identification 

of tobacco use status not only opens the door for successful interventions 

(e.g., clinician advice and treatment), but also guides clinicians to identify 

appropriate interventions based on patients’ tobacco use status and willingness to quit. Based on these findings, the Guideline update recommends 

that clinicians and health care systems seize the office visit for universal 

assessment and intervention. Specifically, ask every patient who presents to 

a health care facility if s/he uses tobacco (Ask), advise all tobacco users to 

quit (Advise), and assess the willingness of all tobacco users to make a quit 

attempt at this time (Assess) (the first 3 of the 5 A’s; see Chapter 3).

Screening for current or past tobacco use will result in four possible responses: (1) the patient uses tobacco and is willing to make a quit attempt 

at this time; (2) the patient uses tobacco but is not willing to make a quit 

attempt at this time; (3) the patient once used tobacco but has since quit; 

and (4) the patient never regularly used tobacco. This Clinical Practice 

Guideline is organized to provide the clinician with simple but effective 

interventions for all of these patient groups (see Figure 2.1).

Figure 2.1. Algorithm for treating tobacco use

Does patient now 

use tobacco?

See Chapter 2

Is patient now 

willing to quit?

Did patient once

use tobacco?

Provide appropriate

tobacco dependence

treatments

See Chapters 3A

and 4

Promote motivation

to quit

See Chapter 3B

Prevent relapsea

See Chapter 3C

Encourage continued

abstinence

YES

YES

NO

NO YES NO

a

Relapse prevention interventions are not necessary in the case of the adult who has not used tobacco for many years.
37

 Chapter 3 Clinical Interventions 

for Tobacco Use and 

Dependence

Background

This section of the Guideline presents specific strategies to guide clinicians 

providing brief interventions (less than 10 minutes). These brief interventions can be provided by all clinicians but are most relevant to clinicians 

who see a wide variety of patients and are bound by time constraints (e.g., 

physicians, nurses, physician assistants, nurse practitioners, medical assistants, dentists, hygienists, respiratory therapists, mental health counselors, 

pharmacists, etc.). The strategies in this chapter are based on the evidence 

described in Chapters 6 and 7, as well as on Panel opinion. Guideline analysis suggests that a wide variety of clinicians can implement these strategies 

effectively. 

Why should members of a busy clinical team consider making the treatment 

of tobacco use a priority? The evidence is compelling: (1) clinicians can 

make a difference with even a minimal (less than 3 minutes) intervention 

(see Chapter 6); (2) a relation exists between the intensity of intervention 

and tobacco cessation outcome (see Chapter 6); (3) even when patients 

are not willing to make a quit attempt at this time, clinician-delivered brief 

interventions enhance motivation and increase the likelihood of future 

quit attempts122 (see Chapter 6); (4) tobacco users are being primed to 

consider quitting by a wide range of societal and environmental factors 

(e.g., public health messages, policy changes, cessation marketing messages, 

family members); (5) there is growing evidence that smokers who receive 

clinician advice and assistance with quitting report greater satisfaction with 

their health care than those who do not;23,87,88 (6) tobacco use interventions 

are highly cost effective (see Chapter 6); and (7) tobacco use has a high case 

fatality rate (up to 50% of long-term smokers will die of a smoking-caused 

disease123).

The goal of these strategies is clear: to change clinical culture and practice 

patterns to ensure that every patient who uses tobacco is identified, 
Treating Tobacco Use and Dependence: 2008 Update

38

advised to quit, and offered scientifically sound treatments. The strategies 

underscore a central theme: it is essential to provide at least a brief 

intervention to every tobacco user at each health care visit. Responsibility 

lies with both the clinician and the health care system to ensure that 

this occurs. Several observations are relevant to this theme. First, 

although many smokers are reluctant to seek intensive treatments,124,125

they nevertheless can receive a brief intervention every time they visit 

a clinician.66,126 Second, institutional support is necessary to ensure 

that all patients who use tobacco are identified and offered appropriate 

treatment (see Chapter 5, Systems Interventions: Importance to Health 

Care Administrators, Insurers, and Purchasers). Third, the time limits 

on primary care physicians in the United States today (median visit = 

12–16 minutes),127,128 as well as reimbursement restrictions, often limit 

providers to brief interventions, although more intensive interventions 

would produce greater success. Finally, given the growing use of electronic 

patient databases, smoker registries, and real-time clinical care prompts, 

brief interventions may be easier to fit into a busy practice and may be 

implemented in a variety of ways. 

This chapter is divided into three sections to guide brief clinician interventions with three types of patients: (A) current tobacco users willing to 

make a quit attempt at this time; (B) current tobacco users unwilling to 

make a quit attempt at this time; and (C) former tobacco users who have 

recently quit. Patients who have never used tobacco or who have been abstinent for an extended period should be congratulated on their status and 

encouraged to maintain their tobacco-free lifestyle. 

Given that more than 70 percent of tobacco users visit a physician and 

more than 50 percent visit a dentist each year,129 it is essential that these 

clinicians be prepared to intervene with all tobacco users. The five major 

components (the “5 A’s”) of a brief intervention in the primary care setting 

are listed in Table 3.1. It is important for a clinician to ask the patient if he 

or she uses tobacco (Strategy A1), advise him or her to quit (Strategy A2), 

and assess willingness to make a quit attempt (Strategy A3). Strategies A1 

to A3 need to be delivered to each tobacco user, regardless of his or her 

willingness to quit.

If the patient is willing to quit, the clinician should assist him or her in 

making a quit attempt by offering medication and providing or referring 

for counseling or additional treatment (Strategy A4), and arrange for fol-
Clinical Interventions for Tobacco Use and Dependence

39

lowup contacts to prevent relapse (Strategy A5). If the patient is unwilling 

to make a quit attempt, the clinician should provide a motivational intervention (Strategies B1 and B2) and arrange to address tobacco dependence 

at the next clinic visit. The Strategy tables below (A1–A5) comprise suggestions for the content and delivery of the 5 A’s. The strategies are designed to 

be brief and require 3 minutes or less of direct clinician time. These intervention components constitute the core elements of a tobacco intervention, 

but they need not be applied in a rigid, invariant manner. For instance, 

the clinician need not deliver all elements personally. One clinician (e.g., a 

medical assistant) may ask about tobacco use status; and a prescribing clinician (e.g., physician, dentist, physician assistant, nurse practitioner) may 

deliver personal advice to quit, assess willingness to quit, and assist with 

medications, but then refer the patient to a tobacco intervention resource 

(e.g., a tobacco cessation quitline, health educator) that would deliver additional treatment to the patient. The clinician would remain responsible 

for the patient receiving appropriate care and subsequent followup, but, as 

with other sorts of health care, an individual clinician would not need to 

Table 3.1. The “5 A’s” model for treating tobacco use and dependence 

Ask about tobacco 

use.

Identify and document tobacco use status for every 

patient at every visit. (Strategy A1)

Advise to quit. In a clear, strong, and personalized manner, urge every 

tobacco user to quit. (Strategy A2)

Assess willingness to 

make a quit attempt.

Is the tobacco user willing to make a quit attempt at this 

time? (Strategy A3)

Assist in quit attempt. For the patient willing to make a quit attempt, offer medication and provide or refer for counseling or additional 

treatment to help the patient quit. (Strategy A4)

For patients unwilling to quit at the time, provide interventions designed to increase future quit attempts. 

(Strategies B1 and B2)

Arrange followup. For the patient willing to make a quit attempt, arrange for 

followup contacts, beginning within the first week after 

the quit date. (Strategy A5)

For patients unwilling to make a quit attempt at the time, 

address tobacco dependence and willingness to quit at 

next clinic visit.
Treating Tobacco Use and Dependence: 2008 Update

40

deliver all care personally.130 Evidence indicates that full implementation 

of the 5 A’s in clinical settings may yield results that are superior to partial 

implementation.131

The effectiveness of tobacco intervention may reflect not only the contributions of the individual clinician, but also the systems and other clinical 

resources available to him or her. For instance, office systems that institutionalize tobacco use assessment and intervention will greatly foster 

the likelihood that the 5 A’s will be delivered (see Chapter 5). The 5 A’s, 

as described in Table 3.1, are consistent with those recommended by the 

NCI132,133 and the American Medical Association,77 as well as others.75,134-137

The clinical situation may suggest delivering these intervention components in an order or format different from that presented, however. For 

example, clinical interventions such as: Ask/Assess, Advise, Agree on a 

goal, Assist, Arrange followup; Ask and Act; and Ask, Advise, and Refer 

have been proposed.116,130,138-140

When “Assisting” smokers, in addition to counseling, all smokers making a 

quit attempt should be offered medication, except when contraindicated or 

with specific populations for which there is insufficient evidence of effectiveness (i.e., pregnant women, smokeless tobacco users, light smokers, and 

adolescents). See Tables 3.2 to 3.11 for guidelines for prescribing medication for treating tobacco use and dependence.

A. For the Patient Willing To Quit 

Strategy A1. Ask—Systematically identify all tobacco users at every visit

Action Strategies for implementation

Implement an 

officewide system 

that ensures that, 

for every patient 

at every clinic 

visit, tobacco use 

status is queried 

and documented.a

Expand the vital signs to include tobacco use, or use an alternative universal identification system.b

 VITAL SIGNS

Blood Pressure: _______________________

Pulse: ________ Weight: ___________

Temperature: _________________________

Respiratory Rate: ______________________

Tobacco Use (circle one): Current Former Never

a

 Repeated assessment is not necessary in the case of the adult who has never used tobacco or has not 

used tobacco for many years and for whom this information is clearly documented in the medical record.

b

 Alternatives to expanding the vital signs include using tobacco use status stickers on all patient charts or 

indicating tobacco use status via electronic medical records or computerized reminder systems.
Clinical Interventions for Tobacco Use and Dependence

41

Strategy A2. Advise—Strongly urge all tobacco users to quit

Action Strategies for implementation

In a clear, strong, 

and personalized 

manner, urge 

every tobacco 

user to quit.

Advice should be:

•	Clear—“It is important that you quit smoking (or using 

chewing tobacco) now, and I can help you.” “Cutting down 

while you are ill is not enough.” “Occasional or light smoking is still dangerous.”

•	Strong—“As your clinician, I need you to know that quitting 

smoking is the most important thing you can do to protect 

your health now and in the future. The clinic staff and I will 

help you.”

•	Personalized—Tie tobacco use to current symptoms and 

health concerns, and/or its social and economic costs, and/

or the impact of tobacco use on children and others in 

the household. “Continuing to smoke makes your asthma 

worse, and quitting may dramatically improve your health.” 

“Quitting smoking may reduce the number of ear infections 

your child has.”

Strategy A3. Assess—Determine willingness to make a quit attempt

Action Strategies for implementation

Assess every 

tobacco user’s 

willingness to 

make a quit 

attempt at the 

time.

Assess patient’s willingness to quit: “Are you willing to give 

quitting a try?”

•	 If the patient is willing to make a quit attempt at the time, 

provide assistance (see Chapter 3A, Strategy A4).

– If the patient will participate in an intensive treatment, 

deliver such a treatment or link/refer to an intensive 

intervention (see Chapter 4).

– If the patient is a member of a special population 

(e.g., adolescent, pregnant smoker, racial/ethnic 

minority), consider providing additional information 

(see Chapter 7).

•	 If the patient clearly states that he or she is unwilling to 

make a quit attempt at the time, provide an intervention 

shown to increase future quit attempts (see Chapter 3B).
Treating Tobacco Use and Dependence: 2008 Update

42

Strategy A4. Assist—Aid the patient in quitting (provide counseling and 

medication)

Action Strategies for implementation

Help the patient 

with a quit plan.

A patient’s preparations for quitting:

•	Set a quit date. Ideally, the quit date should be within 2 weeks.

•	Tell family, friends, and coworkers about quitting, and request 

understanding and support.

•	Anticipate challenges to the upcoming quit attempt, particularly during the critical first few weeks. These include nicotine 

withdrawal symptoms.

•	Remove tobacco products from your environment. Prior to 

quitting, avoid smoking in places where you spend a lot of 

time (e.g., work, home, car). Make your home smoke-free.

Recommend the 

use of approved 

medication,

except when contraindicated or with 

specific populations 

for which there is 

insufficient evidence of effectiveness (i.e., pregnant 

women, smokeless 

tobacco users, light 

smokers, and adolescents).

Recommend the use of medications found to be effective in 

this Guideline (see Table 3.2 for clinical guidelines and Tables 

3.3–3.11 for specific instructions and precautions). Explain how 

these medications increase quitting success and reduce withdrawal symptoms. The first-line medications include: bupropion 

SR, nicotine gum, nicotine inhaler, nicotine lozenge, nicotine 

nasal spray, nicotine patch, and varenicline; second-line medications include: clonidine and nortriptyline. There is insufficient 

evidence to recommend medications for certain populations 

(e.g., pregnant women, smokeless tobacco users, light smokers, 

adolescents).

Provide practical 

counseling (problemsolving/skills 

training).

Abstinence. Striving for total abstinence is essential. Not even a 

single puff after the quit date.141

Past quit experience. Identify what helped and what hurt in 

previous quit attempts. Build on past success.

Anticipate triggers or challenges in the upcoming attempt.

Discuss challenges/triggers and how the patient will successfully

overcome them (e.g., avoid triggers, alter routines).

Alcohol. Because alcohol is associated with relapse, the patient 

should consider limiting/abstaining from alcohol while quitting.

(Note that reducing alcohol intake could precipitate withdrawal 

in alcohol-dependent persons.)

Other smokers in the household. Quitting is more difficult when 

there is another smoker in the household. Patients should encourage housemates to quit with them or to not smoke in their 

presence.

For further description of practical counseling, see Table 6.19.
Clinical Interventions for Tobacco Use and Dependence

43

Action Strategies for implementation

Provide intratreatment social support.

Provide a supportive clinical environment while encouraging 

the patient in his or her quit attempt. “My office staff and I are 

available to assist you.” “I’m recommending treatment that can 

provide ongoing support.” 

For further description of intratreatment social support, see 

Table 6.20.

Provide supplementary materials, 

including information on quitlines.

Sources: Federal agencies, nonprofit agencies, national quitline 

network (1-800-QUIT-NOW), or local/state/tribal health departments/quitlines (see Appendix B for Web site addresses).

Type: Culturally/racially/educationally/age-appropriate for the 

patient.

Location: Readily available at every clinician’s workstation.

For the smoker 

unwilling to quit at 

the time

See Section 3B.

Strategy A5. Arrange—Ensure followup contact

Action Strategies for implementation

Arrange for followup 

contacts, either in 

person or via telephone.

Timing: Followup contact should begin soon after the quit date, 

preferably during the first week. A second followup contact is 

recommended within the first month. Schedule further followup contacts as indicated.

Actions during followup contact: For all patients, identify 

problems already encountered and anticipate challenges in 

the immediate future. Assess medication use and problems. 

Remind patients of quitline support (1-800-QUIT-NOW). Address 

tobacco use at next clinical visit (treat tobacco use as a chronic 

disease). 

For patients who are abstinent, congratulate them on their success. 

If tobacco use has occurred, review circumstances and elicit recommitment to total abstinence. Consider use of or link to more 

intensive treatment (see Chapter 4). 

For smokers unwilling to quit at the 

time

See Section 3B.

Strategy A4. Assist—Aid the patient in quitting (provide counseling and 

medication) (continued)
Treating Tobacco Use and Dependence: 2008 Update

44

Table 3.2. Clinical guidelines for prescribing medication for treating tobacco use 

and dependence 

Who should 

receive medication for tobacco 

use? Are there 

groups of smokers for whom 

medication has 

not been shown 

to be effective?

All smokers trying to quit should be offered medication, except 

when contraindicated or for specific populations for which there is 

insufficient evidence of effectiveness (i.e., pregnant women, smokeless tobacco users, light smokers, and adolescents; see Chapter 7). 

What are 

the first-line 

medications 

recommended 

in this Guideline 

update?

All seven of the FDA-approved medications for treating tobacco 

use are recommended: bupropion SR, nicotine gum, nicotine 

inhaler, nicotine lozenge, nicotine nasal spray, nicotine patch, and 

varenicline. The clinician should consider the first-line medications

shown to be more effective than the nicotine patch alone: 2 mg/day 

varenicline or the combination of long-term nicotine patch use + ad 

libitum nicotine replacement therapy (NRT). Unfortunately, there are 

no well-accepted algorithms to guide optimal selection among the 

first-line medications.

Are there 

contraindications, warnings, 

precautions, 

other concerns, 

and side effects 

regarding 

the first-line 

medications 

recommended 

in this Guideline 

update?

All seven FDA-approved medications have specific contraindications, warnings, precautions, other concerns, and side effects. Refer 

to FDA package inserts for this complete information and FDA updates to the individual drug tables in this document (Tables 3.3–3.9). 

(See information below regarding second-line medications.)

What other 

factors may 

influence 

medication 

selection?

Pragmatic factors also may influence selection, such as insurance

coverage, out-of-pocket patient costs, likelihood of adherence, 

dentures when considering the gum, or dermatitis when considering the patch.

Is a patient’s 

prior experience 

with a medication relevant?

Prior successful experience (sustained abstinence with the medication) suggests that the medication may be helpful to the patient 

in a subsequent quit attempt, especially if the patient found the 

medication to be tolerable and/or easy to use. However, it is difficult 

to draw firm conclusions from prior failure with a medication. Some 

evidence suggests that re-treating relapsed smokers with the same 

medication produces small or no benefit,142,143 whereas other evidence suggests that it may be of substantial benefit.144
Clinical Interventions for Tobacco Use and Dependence

45

What medications should 

a clinician use 

with a patient 

who is highly 

nicotine dependent?

The higher-dose preparations of nicotine gum, patch, and lozenge

have been shown to be effective in highly dependent smokers.145-147

Also, there is evidence that combination NRT therapy may be particularly effective in suppressing tobacco withdrawal symptoms.148,149 

Thus, it may be that NRT combinations are especially helpful for 

highly dependent smokers or those with a history of severe withdrawal.

Is gender a 

consideration 

in selecting a 

medication?

There is evidence that NRT can be effective with both sexes;150-152

however, evidence is mixed as to whether NRT is less effective in 

women than men.153-157 This may encourage the clinician to consider 

use of another type of medication with women, such as bupropion 

SR or varenicline. 

Are cessation 

medications 

appropriate for 

light smokers 

(i.e., < 10 cigarettes/day)?

As noted above, cessation medications have not been shown to be 

beneficial to light smokers. However, if NRT is used with light smokers, clinicians may consider reducing the dose of the medication. No 

adjustments are necessary when using bupropion SR or varenicline.

When should 

second-line 

agents be used 

for treating 

tobacco dependence?

Consider prescribing second-line agents (clonidine and nortriptyline) for patients unable to use first-line medications because of 

contraindications or for patients for whom the group of first-line 

medications has not been helpful. Assess patients for the specific

contraindications, precautions, other concerns, and side effects of 

the second-line agents. Refer to FDA package inserts for this information and to the individual drug tables in this document (Tables 

3.10 and 3.11).

Which medications should 

be considered 

with patients 

particularly concerned about 

weight gain?

Data show that bupropion SR and nicotine replacement therapies, in 

particular 4-mg nicotine gum and 4-mg nicotine lozenge, delay—

but do not prevent—weight gain.

Are there 

medications 

that should 

especially be 

considered for 

patients with a 

past history of 

depression?

Bupropion SR and nortriptyline appear to be effective with this population158-162 (see Chapter 7), but nicotine replacement medications 

also appear to help individuals with a past history of depression. 

Table 3.2. Clinical guidelines for prescribing medication for treating tobacco use 

and dependence (continued)
Treating Tobacco Use and Dependence: 2008 Update

46

Should nicotine 

replacement 

therapies be 

avoided in 

patients with 

a history of 

cardiovascular 

disease?

No. The nicotine patch in particular has been demonstrated as safe

for cardiovascular patients. See Tables 3.3–3.9 and FDA package 

inserts for more complete information.

May tobacco 

dependence 

medications be 

used long-term 

(e.g., up to 6 

months)?

Yes. This approach may be helpful with smokers who report persistent withdrawal symptoms during the course of medications, who 

have relapsed in the past after stopping medication, or who desire 

long-term therapy. A minority of individuals who successfully quit 

smoking use ad libitum NRT medications (gum, nasal spray, inhaler) 

long-term. The use of these medications for up to 6 months does 

not present a known health risk, and developing dependence on 

medications is uncommon. Additionally, the FDA has approved the 

use of bupropion SR, varenicline, and some NRT medications for 

6-month use.

Is medication 

adherence 

important?

Yes. Patients frequently do not use cessation medications as recommended (e.g., they do not use them at recommended doses or for 

recommended durations); this may reduce their effectiveness.

May medications ever be 

combined?

Yes. Among first-line medications, evidence exists that combining 

the nicotine patch long-term ( > 14 weeks) with either nicotine gum 

or nicotine nasal spray, the nicotine patch with the nicotine inhaler, or the nicotine patch with bupropion SR, increases long-term 

abstinence rates relative to placebo treatments. Combining varenicline with NRT agents has been associated with higher rates of side 

effects (e.g., nausea, headaches).

Table 3.3. Clinical use of bupropion SR (See FDA package insert for more complete 

information.)

Clinical use of bupropion SR 150 (FDA approved)

Patient 

selection

Appropriate as a first-line medication for treating tobacco use

Precautions, 

warnings, contraindications, 

and side effects 

(see FDA package insert for 

complete list)

Pregnancy – Pregnant smokers should be encouraged to quit without medication. Bupropion has not been shown to be effective for 

tobacco dependence treatment in pregnant smokers. (Bupropion is 

an FDA pregnancy Class C agent.) Bupropion has not been evaluated 

in breastfeeding patients.

Cardiovascular diseases – Generally well-tolerated; occasional reports of hypertension.

Table 3.2. Clinical guidelines for prescribing medication for treating tobacco use 

and dependence (continued)
Clinical Interventions for Tobacco Use and Dependence

47

Clinical use of bupropion SR 150 (FDA approved)

Precautions, 

contraindications, and side 

effects 

(continued)

Side effects – The most common reported side effects were insomnia (35–40%) and dry mouth (10%).

Contraindications – Bupropion SR is contraindicated in individuals 

who have a history of seizures or eating disorders, who are taking 

another form of bupropion, or who have used an MAO inhibitor in 

the past 14 days.

Dosage Patients should begin bupropion SR treatment 1–2 weeks before 

they quit smoking. Patients should begin with a dose of 150 mg 

every morning for 3 days, then increase to 150 mg twice daily. Dosage should not exceed 300 mg per day. Dosing at 150 mg twice daily 

should continue for 7–12 weeks. For long-term therapy, consider use 

of bupropion SR 150 mg for up to 6 months postquit.

Availability Prescription only

Prescribing 

instructions

Stopping smoking prior to quit date – Recognize that some patients 

may lose their desire to smoke prior to their quit date or will spontaneously reduce the amount they smoke.

Dosing information – If insomnia is marked, taking the PM dose 

earlier (in the afternoon, at least 8 hours after the first dose) may 

provide some relief.

Alcohol – Use alcohol only in moderation.

Costa 1 box of 60 tablets, 150 mg = $97 per month (generic); $197 to $210 

(Brand name)

a Cost data were established by averaging the retail price of the medication at national chain pharmacies in Atlanta, GA, Los Angeles, CA, Milwaukee, WI , Sunnyside, NY, and listed online during 

January 2008 and may not reflect discounts available to health plans and others.

Table 3.4. Clinical use of nicotine gum (See FDA package insert for more complete 

information.)

Clinical use of nicotine gum (FDA approved)

Patient 

selection

Appropriate as a first-line medication for treating tobacco use

Precautions, 

warnings, contraindications, 

and side effects 

(see FDA package insert for 

complete list)

Pregnancy – Pregnant smokers should be encouraged to quit without medication. Nicotine gum has not been shown to be effective 

for treating tobacco dependence in pregnant smokers. (Nicotine 

gum is an FDA pregnancy Class D agent.) Nicotine gum has not been 

evaluated in breastfeeding patients.

Table 3.3. Clinical use of bupropion SR (See FDA package insert for more complete 

information.) (continued)
Treating Tobacco Use and Dependence: 2008 Update

48

Clinical use of nicotine gum (FDA approved)

Precautions, 

warnings, contraindications, 

and side effects 

(see FDA package insert for 

complete list) 

(continued)

Cardiovascular diseases – NRT is not an independent risk factor for 

acute myocardial events. NRT should be used with caution among 

particular cardiovascular patient groups: those in the immediate

(within 2 weeks) postmyocardial infarction period, those with serious arrhythmias, and those with unstable angina pectoris.

Side effects – Common side effects of nicotine gum include mouth 

soreness, hiccups, dyspepsia, and jaw ache. These effects are generally mild and transient and often can be alleviated by correcting the 

patient’s chewing technique (see prescribing instructions, below).

Dosage Nicotine gum (both regular and flavored) is available in 2-mg and

4-mg (per piece) doses. The 2-mg gum is recommended for patients smoking less than 25 cigarettes per day; the 4-mg gum is 

recommended for patients smoking 25 or more cigarettes per day. 

Smokers should use at least one piece every 1 to 2 hours for the first 

6 weeks; the gum should be used for up to 12 weeks with no more 

than 24 pieces to be used per day. 

Availability OTC only

Prescribing 

instructions

Chewing technique – Gum should be chewed slowly until a “peppery” or “flavored” taste emerges, then “parked” between cheek and 

gum to facilitate nicotine absorption through the oral mucosa. Gum 

should be slowly and intermittently “chewed and parked” for about 

30 minutes or until the taste dissipates.

Absorption – Acidic beverages (e.g., coffee, juices, soft drinks) interfere with the buccal absorption of nicotine, so eating and drinking 

anything except water should be avoided for 15 minutes before or

during chewing.

Dosing information – Patients often do not use enough prn NRT 

medicines to obtain optimal clinical effects. Instructions to chew the 

gum on a fixed schedule (at least one piece every 1–2 hours) for at

least 1–3 months may be more beneficial than ad libitum use. 

Costa 2 mg (packaged in different amounts), boxes of 100–170 pieces = 

$48 (quantity used determines how long supply lasts)

4 mg (packaged in different amounts), boxes of 100–110 pieces = 

$63 (quantity used determines how long supply lasts)

a Cost data were established by averaging the retail price of the medication at national chain pharmacies in Atlanta, GA, Los Angeles, CA, Milwaukee, WI , Sunnyside, NY, and listed online during 

January 2008 and may not reflect discounts available to health plans and others.

Table 3.4. Clinical use of nicotine gum (See FDA package insert for more complete 

information.) (continued)
Clinical Interventions for Tobacco Use and Dependence

49

Table 3.5. Clinical use of the nicotine inhaler (See FDA package insert for more 

complete information.)

Clinical use of nicotine inhaler (FDA approved)

Patient 

selection

Appropriate as a first-line medication for treating tobacco use

Precautions, 

warnings, contraindications, 

and side effects 

(see FDA package insert for 

complete list) 

Pregnancy – Pregnant smokers should be encouraged to quit 

without medication. The nicotine inhaler has not been shown to be 

effective for treating tobacco dependence in pregnant smokers. (The 

nicotine inhaler is an FDA pregnancy Class D agent.) The nicotine 

inhaler has not been evaluated in breastfeeding patients.

Cardiovascular diseases – NRT is not an independent risk factor for 

acute myocardial events. NRT should be used with caution among 

particular cardiovascular patient groups: those in the immediate

(within 2 weeks) postmyocardial infarction period, those with serious 

arrhythmias, and those with unstable angina pectoris.

Local irritation reactions – Local irritation in the mouth and throat 

was observed in 40% of patients using the nicotine inhaler. Coughing (32%) and rhinitis (23%) also were common. Severity was generally rated as mild, and the frequency of such symptoms declined 

with continued use.

Dosage A dose from the nicotine inhaler consists of a puff or inhalation. Each 

cartridge delivers a total of 4 mg of nicotine over 80 inhalations. Recommended dosage is 6–16 cartridges/day. Recommended duration 

of therapy is up to 6 months. Instruct patient to taper dosage during 

the final 3 months of treatment.

Availability Prescription only

Prescribing 

instructions

Ambient temperature – Delivery of nicotine from the inhaler declines significantly at temperatures below 40°F. In cold weather, the 

inhaler and cartridges should be kept in an inside pocket or other

warm area.

Absorption – Acidic beverages (e.g., coffee, juices, soft drinks) interfere with the buccal absorption of nicotine, so eating and drinking 

anything except water should be avoided for 15 minutes before or

during use of the inhaler. 

Dosing information – Patients often do not use enough prn NRT 

medicines to obtain optimal clinical effects. Use is recommended for 

up to 6 months, with gradual reduction in frequency of use over the 

last 6–12 weeks of treatment. Best effects are achieved by frequent

puffing of the inhaler and using at least six cartridges/day. 

Costa 1 box of 168 10-mg cartridges = $196 (quantity used determines 

how long supply lasts)

a Cost data were established by averaging the retail price of the medication at national chain pharmacies in Atlanta, GA, Los Angeles, CA, Milwaukee, WI , Sunnyside, NY, and listed online during 

January 2008 and may not reflect discounts available to health plans and others.
Treating Tobacco Use and Dependence: 2008 Update

50

Table 3.6. Clinical use of the nicotine lozenge (See FDA package insert for more 

complete information.)

Clinical use of nicotine lozenge (FDA approved)

Patient 

selection

Appropriate as a first-line medication for treating tobacco use

Precautions, 

warnings, contraindications, 

and side effects 

(see FDA package insert for 

complete list) 

Pregnancy – Pregnant smokers should be encouraged to quit 

without medication. The nicotine lozenge has not been shown to 

be effective for treating tobacco dependence for pregnant smokers. The nicotine lozenge has not been evaluated in breastfeeding 

patients. Because the lozenge was approved as an OTC agent, it was

not evaluated by the FDA for teratogenicity.

Cardiovascular diseases – NRT is not an independent risk factor for 

acute myocardial events. NRT should be used with caution among 

particular cardiovascular patient groups: those in the immediate

(within 2 weeks) postmyocardial infarction period, those with serious arrhythmias, and those with unstable angina pectoris.

Side effects – The most common side effects of the nicotine lozenge 

are nausea, hiccups, and heartburn. Individuals on the 4-mg lozenge 

also had increased rates of headache and coughing (less than 10% 

of participants).

Dosage Nicotine lozenges are available in 2-mg and 4-mg (per piece) doses. 

The 2-mg lozenge is recommended for patients who smoke their 

first cigarette more than 30 minutes after waking, and the 4-mg 

lozenge is recommended for patients who smoke their first cigarette 

within 30 minutes of waking. Generally, smokers should use at least 

nine lozenges per day in the first 6 weeks; the lozenge should be 

used for up to 12 weeks, with no more than 20 lozenges to be used 

per day. 

Availability OTC only

Prescribing 

instructions

Lozenge use – The lozenge should be allowed to dissolve in the 

mouth rather than chewing or swallowing it.

Absorption – Acidic beverages (e.g., coffee, juices, soft drinks) interfere with the buccal absorption of nicotine, so eating and drinking 

anything except water should be avoided for 15 minutes before or

during use of the nicotine lozenge.

Dosing information – Patients often do not use enough prn NRT 

medicines to obtain optimal clinical effects. Generally, patients 

should use 1 lozenge every 1–2 hours during the first 6 weeks of 

treatment, using a minimum of 9 lozenges/day, then decrease lozenge use to 1 lozenge every 2–4 hours during weeks 7–9, and then 

decrease to 1 lozenge every 4–8 hours during weeks 10–12. 

Costa 2 mg, 72 lozenges per box = $34 (quantity used determines how 

long supply lasts)

4 mg, 72 lozenges per box = $39 (quantity used determines how 

long supply lasts)

a Cost data were established by averaging the retail price of the medication at national chain pharmacies in Atlanta, GA, Los Angeles, CA, Milwaukee, WI , Sunnyside, NY, and listed online during 

January 2008 and may not reflect discounts available to health plans and others.
Clinical Interventions for Tobacco Use and Dependence

51

Table 3.7. Clinical use of the nicotine nasal spray (See FDA package insert for more 

complete information.)

Clinical use of nicotine nasal spray (FDA approved)

Patient 

selection

Appropriate as a first-line medication for treating tobacco use

Precautions, 

warnings, contraindications, 

and side effects 

(see FDA package insert for 

complete list)

Pregnancy – Pregnant smokers should be encouraged to quit without medication. Nicotine nasal spray has not been shown to be effective for treating tobacco dependence in pregnant smokers. (Nicotine 

nasal spray is an FDA pregnancy Class D agent.) Nicotine nasal spray 

has not been evaluated in breastfeeding patients.

Cardiovascular diseases – NRT is not an independent risk factor for 

acute myocardial events. NRT should be used with caution among 

particular cardiovascular patient groups: those in the immediate

(within 2 weeks) postmyocardial infarction period, those with serious 

arrhythmias, and those with unstable angina pectoris.

Nasal/airway reactions – Some 94% of users report moderate to severe nasal irritation in the first 2 days of use; 81% still reported nasal 

irritation after 3 weeks, although rated severity typically was mild to 

moderate. Nasal congestion and transient changes in sense of smell 

and taste also were reported. Nicotine nasal spray should not be

used in persons with severe reactive airway disease.

Dependency – Nicotine nasal spray produces higher peak nicotine 

levels than other NRTs and has the highest dependence potential. 

Approximately 15–20% of patients report using the active spray 

for longer periods than recommended (6–12 months); 5% used the 

spray at a higher dose than recommended.

Dosage A dose of nicotine nasal spray consists of one 0.5-mg dose delivered 

to each nostril (1 mg total). Initial dosing should be 1–2 doses per

hour, increasing as needed for symptom relief. Minimum recommended treatment is 8 doses/day, with a maximum limit of 40 

doses/day (5 doses/hour). Each bottle contains approximately 100 

doses. Recommended duration of therapy is 3–6 months.

Availability Prescription only

Prescribing 

instructions

Dosing information – Patients should not sniff, swallow, or inhale 

through the nose while administering doses, as this increases irritating effects. The spray is best delivered with the head tilted slightly 

back. 

Costa $49 per bottle (quantity used determines how long supply lasts)

a Cost data were established by averaging the retail price of the medication at national chain pharmacies in Atlanta, GA, Los Angeles, CA, Milwaukee, WI , Sunnyside, NY, and listed online during 

January 2008 and may not reflect discounts available to health plans and others.
Treating Tobacco Use and Dependence: 2008 Update

52

Table 3.8. Clinical use of the nicotine patch (See FDA package insert for more complete information.)

Clinical use of the nicotine patch (FDA approved)

Patient 

selection

Appropriate as a first-line medication for treating tobacco use

Precautions, 

warnings, contraindications, 

and side effects 

(see FDA package insert for 

complete list) 

Pregnancy – Pregnant smokers should be encouraged to quit without medication. The nicotine patch has not been shown to be effective for treating tobacco dependence treatment in pregnant smokers. (The nicotine patch is an FDA pregnancy Class D agent.) The 

nicotine patch has not been evaluated in breastfeeding patients.

Cardiovascular diseases – NRT is not an independent risk factor for 

acute myocardial events. NRT should be used with caution among 

particular cardiovascular patient groups: those in the immediate

(within 2 weeks) postmyocardial infarction period, those with serious arrhythmias, and those with unstable angina pectoris.

Skin reactions – Up to 50% of patients using the nicotine patch will 

experience a local skin reaction. Skin reactions usually are mild and

self-limiting, but occasionally worsen over the course of therapy. 

Local treatment with hydrocortisone cream (1%) or triamcinolone 

cream (0.5%) and rotating patch sites may ameliorate such local 

reactions. In fewer than 5% of patients, such reactions require the 

discontinuation of nicotine patch treatment.

Other side effects – insomnia and/or vivid dreams

Dosage Treatment of 8 weeks or less has been shown to be as efficacious as 

longer treatment periods. Patches of different doses sometimes are 

available as well as different recommended dosing regimens. The 

dose and duration recommendations in this table are examples. Clinicians should consider individualizing treatment based on specific 

patient characteristics, such as previous experience with the patch, 

amount smoked, degree of dependence, etc. 

Availability OTC or prescription

Type Duration Dosage

Step-Down 

Dosage

4 weeks

then 2 weeks

then 2 weeks

21 mg/24 hours

14 mg/24 hours

7 mg/24 hours

Single Dosage Both a 22 mg/24 hours and an 11 mg/24 hours (for lighter smokers) 

dose are available in a one-step patch regimen.
Clinical Interventions for Tobacco Use and Dependence

53

Clinical use of the nicotine patch (FDA approved)

Prescribing 

instructions

Location – At the start of each day, the patient should place a new 

patch on a relatively hairless location, typically between the neck 

and waist, rotating the site to reduce local skin irritation.

Activities – No restrictions while using the patch

Dosing information – Patches should be applied as soon as the 

patient wakes on the quit day. With patients who experience sleep 

disruption, have the patient remove the 24-hour patch prior to bedtime, or use the 16-hour patch (designed for use while the patient is 

awake).

Costa 7 mg, box = $37 (quantity used determines how long supply lasts)

14 mg, box = $47 (quantity used determines how long supply lasts)

21 mg, box = $48 (quantity used determines how long supply lasts)

a Cost data were established by averaging the retail price of the medication at national chain pharmacies in Atlanta, GA, Los Angeles, CA, Milwaukee, WI , Sunnyside, NY, and listed online during 

January 2008 and may not reflect discounts available to health plans and others.

Table 3.9. Clinical use of varenicline (See FDA package insert for more complete 

information.)

Clinical use of varenicline (FDA approved)

Patient 

selection

Appropriate as a first-line medication for treating tobacco use

Precautions, 

warnings, contraindications, 

and side effects 

(see FDA package insert for 

complete list)

Pregnancy – Pregnant smokers should be encouraged to quit without medication. Varenicline has not been shown to be effective for 

treating tobacco dependence in pregnant smokers. (Varenicline is 

an FDA pregnancy Class C agent.) Varenicline has not been evaluated in breastfeeding patients.

Cardiovascular diseases – Not contraindicated

Precautions – Use with caution in patients with significant kidney 

disease (creatinine clearance < 30mL/min) or who are on dialysis. 

Dose should be reduced with these patients. Patients taking varenicline may experience impairment of the ability to drive or operate 

heavy machinery.

Table 3.8. Clinical use of the nicotine patch (See FDA package insert for more complete information.) (continued)
Treating Tobacco Use and Dependence: 2008 Update

54

Clinical use of varenicline (FDA approved)

Precautions, 

warnings, contraindications, 

and side effects 

(see FDA package insert for 

complete list)

(continued)

Warning – In February 2008, the FDA added a warning regarding 

the use of varenicline. Specifically, it noted that depressed mood, 

agitation, changes in behavior, suicidal ideation, and suicide have 

been reported in patients attempting to quit smoking while using 

varenicline. The FDA recommends that patients should tell their 

health care provider about any history of psychiatric illness prior to 

starting this medication, and clinicians should monitor patients for

changes in mood and behavior when prescribing this medication. 

In light of these FDA recommendations, clinicians should consider 

eliciting information on their patients’ psychiatric history.

Side effects – Nausea, trouble sleeping, abnormal/vivid/strange 

dreams 

Dosage Start varenicline 1 week before the quit date at 0.5 mg once daily for 

3 days, followed by 0.5 mg twice daily for 4 days, followed by 1 mg 

twice daily for 3 months. Varenicline is approved for a maintenance 

indication for up to 6 months. Note: Patient should be instructed 

to quit smoking on day 8, when dosage is increased to 1 mg twice 

daily.

Availability Prescription only

Prescribing 

instructions

Stopping smoking prior to quit date – Recognize that some patients 

may lose their desire to smoke prior to their quit date or will spontaneously reduce the amount they smoke.

Dosing information –To reduce nausea, take on a full stomach. To 

reduce insomnia, take second pill at supper rather than bedtime.

Costa 1 mg, box of 56 = $131 (about 30-day supply)

a Cost data were established by averaging the retail price of the medication at national chain pharmacies in Atlanta, GA, Los Angeles, CA, Milwaukee, WI , Sunnyside, NY, and listed online during 

January 2008 and may not reflect discounts available to health plans and others.

Table 3.9. Clinical use of varenicline (See FDA package insert for more complete 

information.) (continued)
Clinical Interventions for Tobacco Use and Dependence

55

Table 3.10. Clinical use of clonidine (See FDA package insert for more complete 

information.)

Clinical use of clonidine (not FDA approved for smoking cessation)

Patient 

selection

Appropriate as a second-line medication for treating tobacco use

Precautions, 

warnings, contraindications, 

and side effects 

(see FDA package insert for 

complete list) 

Pregnancy – Pregnant smokers should be encouraged to quit 

without medication. Clonidine has not been shown to be effective 

for tobacco cessation in pregnant smokers. (Clonidine is an FDA 

pregnancy Class C agent.) Clonidine has not been evaluated in 

breastfeeding patients.

Activities – Patients who engage in potentially hazardous activities, 

such as operating machinery or driving, should be advised of a possible sedative effect of clonidine.

Side effects – Most commonly reported side effects include dry 

mouth (40%), drowsiness (33%), dizziness (16%), sedation (10%), and 

constipation (10%). As an antihypertensive medication, clonidine

can be expected to lower blood pressure in most patients. Therefore, 

clinicians should monitor blood pressure when using this medication.

Rebound hypertension – When stopping clonidine therapy, failure 

to reduce the dose gradually over a period of 2–4 days may result 

in a rapid increase in blood pressure, agitation, confusion, and/or

tremor.

Dosage Doses used in various clinical trials have varied significantly, from 

0.15–0.75 mg/day by mouth and from 0.10–0.20 mg/day transdermal (TTS), without a clear dose-response relation to treatment 

outcomes. Initial dosing is typically 0.10 mg b.i.d. PO or 0.10 mg/day 

TTS, increasing by 0.10 mg/day per week if needed. The dose duration also varied across the clinical trials, ranging from 3–10 weeks.

Availability Oral – Prescription only

Transdermal – Prescription only

Prescribing 

instructions

Initiate – Initiate clonidine shortly before (up to 3 days), or on the 

quit date.

Dosing information – If the patient is using transdermal clonidine, 

at the start of each week, he or she should place a new patch on a 

relatively hairless location between the neck and waist. Users should 

not discontinue clonidine therapy abruptly.

Costa Oral – .1 mg, box of 60 = $13 (daily dosage determines how long 

supply lasts)

Transdermal – 4-pack TTS = $106

a Cost data were established by averaging the retail price of the medication at national chain pharmacies in Atlanta, GA, Los Angeles, CA, Milwaukee, WI , Sunnyside, NY, and listed online during 

January 2008 and may not reflect discounts available to health plans and others.
Treating Tobacco Use and Dependence: 2008 Update

56

Table 3.11. Clinical use of nortriptyline (See FDA package insert for more complete 

information.)

Clinical use of nortriptyline 

(not FDA approved for smoking cessation)

Patient selection Appropriate as a second-line medication for treating tobacco use

Precautions, warnings, contraindications, and side 

effects (see FDA 

package insert for 

complete list) 

Pregnancy – Pregnant smokers should be encouraged to quit 

without medication. Nortriptyline has not been shown to be effective for tobacco cessation in pregnant smokers. (Nortriptyline 

is an FDA pregnancy Class D agent.) Nortriptyline has not been 

evaluated in breastfeeding patients.

Side effects – Most commonly reported side effects include 

sedation, dry mouth (64–78%), blurred vision (16%), urinary 

retention, lightheadedness (49%), and shaky hands (23%).

Activities – Nortriptyline may impair the mental and/or physical 

abilities required for the performance of hazardous tasks, such 

as operating machinery or driving a car; therefore, the patient 

should be warned accordingly.

Cardiovascular and other effects – Because of the risk of arrhythmias and impairment of myocardial contractility, use with 

caution in patients with cardiovascular disease. Do not co-administer with MAO inhibitors.

Dosage Doses used in smoking cessation trials have initiated treatment 

at a dose of 25 mg/day, increasing gradually to a target dose of 

75–100 mg/day. Duration of treatment used in smoking cessation trials has been approximately 12 weeks, although clinicians 

may consider extending treatment for up to 6 months.

Availability Nortriptyline HCl – prescription only

Prescribing instructions

Initiate – Therapy is initiated 10–28 days before the quit date to 

allow nortriptyline to reach steady state at the target dose.

Therapeutic monitoring – Although therapeutic blood levels 

for smoking cessation have not been determined, therapeutic 

monitoring of plasma nortriptyline levels should be considered 

under American Psychiatric Association Guidelines for treating patients with depression. Clinicians may choose to assess 

plasma nortriptyline levels as needed.163

Dosing information – Users should not discontinue nortriptyline 

abruptly because of withdrawal effects.

Overdose may produce severe and life-threatening cardiovascular toxicity, as well as seizures and coma. Risk of overdose should 

be considered carefully before using nortriptyline.

Costa 25 mg, box of 60 = $24 (daily dosage determines how long supply lasts)

a Cost data were established by averaging the retail price of the medication at national chain pharmacies in Atlanta, GA, Los Angeles, CA, Milwaukee, WI , Sunnyside, NY, and listed online during 

January 2008 and may not reflect discounts available to health plans and others.
Clinical Interventions for Tobacco Use and Dependence

57

B. For the Patient Unwilling To Quit

Promoting the Motivation To Quit

All patients entering a health care setting should have their tobacco use 

status assessed routinely. Clinicians should advise all tobacco users to quit 

and then assess a patient’s willingness to make a quit attempt. For patients 

not ready to make a quit attempt at the time, clinicians should use a brief 

intervention designed to promote the motivation to quit.

Patients unwilling to make a quit attempt during a visit may lack information about the harmful effects of tobacco use and the benefits of quitting, 

may lack the required financial resources, may have fears or concerns 

about quitting, or may be demoralized because of previous relapse.164-167

Such patients may respond to brief motivational interventions that are 

based on principles of Motivational Interviewing (MI),168 a directive, 

patient-centered counseling intervention.169 There is evidence that MI is 

effective in increasing future quit attempts;170-174 however, it is unclear that 

MI is successful in boosting abstinence among individuals motivated to 

quit smoking.173,175,176

Clinicians employing MI techniques focus on exploring a tobacco user’s 

feelings, beliefs, ideas, and values regarding tobacco use in an effort to 

uncover any ambivalence about using tobacco.169,177,178 Once ambivalence 

is uncovered, the clinician selectively elicits, supports, and strengthens the 

patient’s “change talk” (e.g., reasons, ideas, needs for eliminating tobacco 

use) and “commitment language” (e.g., intentions to take action to change 

smoking behavior, such as not smoking in the home). MI researchers 

have found that having patients use their own words to commit to change 

is more effective than clinician exhortations, lectures, or arguments for 

quitting, which tend to increase rather than lessen patient resistance to 

change.177

The four general principles that underlie MI are: (1) express empathy,

(2) develop discrepancy, (3) roll with resistance, and (4) support self-efficacy.168,179 Specific MI counseling strategies that are based on these principles 

are listed in Strategy B1. Because this is a specialized technique, it may be 

beneficial to have a member of the clinical staff receive training in motivational interviewing. The content areas that should be addressed in a motivational counseling intervention can be captured by the “5 R’s”: relevance, 

risks, rewards, roadblocks, and repetition (Strategy B2). Research suggests 

that the “5 R’s” enhance future quit attempts.169,180
Treating Tobacco Use and Dependence: 2008 Update

58

Strategy B1. Motivational interviewing strategies

Express

empathy.

•	Use open-ended questions to explore:

– The importance of addressing smoking or other tobacco use 

(e.g., “How important do you think it is for you to quit smoking?”)

– Concerns and benefits of quitting (e.g., “What might happen if 

you quit?”)

•	Use reflective listening to seek shared understanding:

– Reflect words or meaning (e.g., “So you think smoking helps you 

to maintain your weight.”).

– Summarize (e.g., “What I have heard so far is that smoking is 

something you enjoy. On the other hand, your boyfriend hates 

your smoking, and you are worried you might develop a serious 

disease.”).

•	Normalize feelings and concerns (e.g., “Many people worry about 

managing without cigarettes.”).

•	Support the patient’s autonomy and right to choose or reject 

change (e.g., “I hear you saying you are not ready to quit smoking 

right now. I’m here to help you when you are ready.”).

Develop

discrepancy.

•	Highlight the discrepancy between the patient’s present behavior 

and expressed priorities, values, and goals (e.g., “It sounds like you 

are very devoted to your family. How do you think your smoking is 

affecting your children?”). 

•	Reinforce and support “change talk” and “commitment” language: 

– “So, you realize how smoking is affecting your breathing and 

making it hard to keep up with your kids.” 

– “It’s great that you are going to quit when you get through this 

busy time at work.”

•	Build and deepen commitment to change:

– “There are effective treatments that will ease the pain of quitting, including counseling and many medication options.”

– “We would like to help you avoid a stroke like the one your 

father had.”

Roll with 

resistance.

•	Back off and use reflection when the patient expresses resistance:

– “Sounds like you are feeling pressured about your smoking.”

•	Express empathy: 

– “You are worried about how you would manage withdrawal 

symptoms.” 

•	Ask permission to provide information:

– “Would you like to hear about some strategies that can help you 

address that concern when you quit?”

Support

self-efficacy.

•	Help the patient to identify and build on past successes: 

– ”So you were fairly successful the last time you tried to quit.”

•	Offer options for achievable small steps toward change:

– Call the quitline (1-800-QUIT-NOW) for advice and information.

– Read about quitting benefits and strategies. 

– Change smoking patterns (e.g., no smoking in the home).

– Ask the patient to share his or her ideas about quitting strategies.
Clinical Interventions for Tobacco Use and Dependence

59

Strategy B2. Enhancing motivation to quit tobacco—the “5 R’s”

Relevance Encourage the patient to indicate why quitting is personally relevant, 

being as specific as possible. Motivational information has the greatest impact if it is relevant to a patient’s disease status or risk, family or 

social situation (e.g., having children in the home), health concerns, 

age, gender, and other important patient characteristics (e.g., prior 

quitting experience, personal barriers to cessation).

Risks The clinician should ask the patient to identify potential negative consequences of tobacco use. The clinician may suggest and highlight 

those that seem most relevant to the patient. The clinician should

emphasize that smoking low-tar/low-nicotine cigarettes or use of 

other forms of tobacco (e.g., smokeless tobacco, cigars, and pipes) 

will not eliminate these risks. Examples of risks are: 

•	Acute risks: Shortness of breath, exacerbation of asthma, increased 

risk of respiratory infections, harm to pregnancy, impotence, infertility.

•	Long-term risks: Heart attacks and strokes, lung and other cancers 

(e.g., larynx, oral cavity, pharynx, esophagus, pancreas, stomach, 

kidney, bladder, cervix, and acute myelocytic leukemia), chronic 

obstructive pulmonary diseases (chronic bronchitis and emphysema), osteoporosis, long-term disability, and need for extended 

care.

•	Environmental risks: Increased risk of lung cancer and heart disease 

in spouses; increased risk for low birth-weight, sudden infant death 

syndrome (SIDS), asthma, middle ear disease, and respiratory infections in children of smokers.

Rewards The clinician should ask the patient to identify potential benefits of 

stopping tobacco use. The clinician may suggest and highlight those 

that seem most relevant to the patient. Examples of rewards follow:

•	Improved health 

•	Food will taste better

•	Improved sense of smell

•	Saving money

•	Feeling better about oneself

•	Home, car, clothing, breath will smell better

•	Setting a good example for children and decreasing the likelihood

that they will smoke

•	Having healthier babies and children

•	Feeling better physically

•	Performing better in physical activities

•	Improved appearance, including reduced wrinkling/aging of skin 

and whiter teeth
Treating Tobacco Use and Dependence: 2008 Update

60

Roadblocks The clinician should ask the patient to identify barriers or impediments to quitting and provide treatment (problemsolving counseling, medication) that could address barriers. Typical barriers might 

include:

•	 Withdrawal symptoms

•	 Fear of failure

•	 Weight gain

•	 Lack of support

•	 Depression

•	 Enjoyment of tobacco

•	 Being around other tobacco users

•	 Limited knowledge of effective treatment options

Repetition The motivational intervention should be repeated every time an 

unmotivated patient visits the clinic setting. Tobacco users who have 

failed in previous quit attempts should be told that most people

make repeated quit attempts before they are successful.

C. For the Patient Who Has Recently Quit

Treatments for the Recent Quitter

Smokers who have recently quit face a high risk of relapse. Although most 

relapse occurs early in the quitting process,96,101,181 some relapse occurs 

months or even years after the quit date.181-184 Numerous studies have been 

conducted to identify treatments that can reduce the likelihood of future 

relapse. These studies attempt to reduce relapse either by including special 

counseling or therapy in the cessation treatment, or by providing additional treatment to smokers who have previously quit. In general, such studies 

have failed to identify either counseling or medication treatments that are 

effective in lessening the likelihood of relapse,185 although there is some evidence that special mailings can reduce the likelihood of relapse.186,187 Thus, 

at present, the best strategy for producing high long-term abstinence rates 

appears to be use of the most effective cessation treatments available; that 

is, the use of evidence-based cessation medication during the quit attempt 

and relatively intense cessation counseling (e.g., four or more sessions that 

are 10 minutes or more in length). 

Ex-smokers often report problems that have been worsened by smoking 

withdrawal or that coexisted with their smoking. If a clinician encounters 

a tobacco user who recently quit, the clinician might reinforce the patient’s 

Strategy B2. Enhancing motivation to quit tobacco—the “5 R’s” (continued)
Clinical Interventions for Tobacco Use and Dependence

61

success at quitting, review the benefits of quitting, and assist the patient in 

resolving any residual problems arising from quitting (Strategy C1). Such 

expressions of interest and involvement on the part of the clinician might 

encourage the patient to seek additional help with cessation should she 

or he ultimately relapse. When the clinician encounters a patient who is 

abstinent from tobacco and is no longer engaged in cessation treatment, 

the clinician may wish to acknowledge a patient’s success in quitting. The 

abstinent former smoker also may experience problems related to cessation 

that deserve treatment in their own right (see Strategy C2). 

Strategy C1. Intervening with the patient who has recently quit

The former tobacco user should receive congratulations on any success and strong 

encouragement to remain abstinent.

When encountering a recent quitter, use open-ended questions relevant to the topics 

below to discover if the patient wishes to discuss issues related to quitting:

•	The benefits, including potential health benefits, the patient may derive from 

cessation

•	Any success the patient has had in quitting (duration of abstinence, reduction in 

withdrawal, etc.)

•	The problems encountered or anticipated threats to maintaining abstinence (e.g., 

depression, weight gain, alcohol, other tobacco users in the household, significant 

stressors)

•	A medication check-in, including effectiveness and side effects if the patient is still 

taking medication

Strategy C2. Addressing problems encountered by former smokers

A patient who previously smoked might identify a problem that negatively affects 

health or quality of life. Specific problems likely to be reported by former smokers and 

potential responses follow:

Problems Responses

Lack of support 

for cessation

•	 Schedule followup visits or telephone calls with the patient.

•	 Urge the patient to call the national quitline network (1-800-QUITNOW) or other local quitline.

•	 Help the patient identify sources of support within his or her environment.

•	 Refer the patient to an appropriate organization that offers counseling or support.

Negative mood 

or depression

•	 If significant, provide counseling, prescribe appropriate medication, or refer the patient to a specialist.
Treating Tobacco Use and Dependence: 2008 Update

62

Problems Responses

Strong or 

prolonged

withdrawal 

symptoms

•	 If the patient reports prolonged craving or other withdrawal 

symptoms, consider extending the use of an approved medication or adding/combining medications to reduce strong withdrawal symptoms.

Weight gain •	 Recommend starting or increasing physical activity.

•	 Reassure the patient that some weight gain after quitting is common and usually is self-limiting.

•	 Emphasize the health benefits of quitting relative to the health 

risks of modest weight gain.

•	 Emphasize the importance of a healthy diet and active lifestyle.

•	 Suggest low-calorie substitutes such as sugarless chewing gum, 

vegetables, or mints.

•	 Maintain the patient on medication known to delay weight gain 

(e.g., bupropion SR, NRTs—particularly 4-mg nicotine gum147—

and lozenge.

•	 Refer the patient to a nutritional counselor or program.

Smoking lapses •	 Suggest continued use of medications, which can reduce the 

likelihood that a lapse will lead to a full relapse.

•	 Encourage another quit attempt or a recommitment to total 

abstinence.

•	 Reassure that quitting may take multiple attempts, and use the 

lapse as a learning experience.

•	 Provide or refer for intensive counseling.

Strategy C2. Addressing problems encountered by former smokers (continued)
63

 Chapter 4 Intensive Interventions 

for Tobacco Use and 

Dependence

Background

Intensive tobacco dependence treatment can be provided by any suitably 

trained clinician. The evidence in Chapter 6 shows that intensive tobacco 

dependence treatment is more effective than brief treatment. Intensive 

interventions (i.e., more comprehensive treatments that may occur over 

multiple visits for longer periods of time and that may be provided by more 

than one clinician) are appropriate for any tobacco user willing to participate in them; neither their effectiveness nor cost-effectiveness is limited to 

a subpopulation of tobacco users (e.g., heavily dependent smokers).188-194

In addition, patients, even those not ready to quit, have reported increased 

satisfaction with their overall health care as tobacco counseling intensity 

increases.50,88

In many cases, intensive tobacco dependence interventions are provided 

by clinicians who specialize in the treatment of tobacco dependence. Such 

specialists are not defined by their certification, professional affiliation, or 

by the field in which they trained. Rather, specialists view tobacco dependence treatment as a primary professional role. Specialists possess the 

skills, knowledge, and training to provide effective interventions across a 

range of intensities. They often are affiliated with programs offering intensive treatment interventions or services (e.g., programs with staff dedicated 

to tobacco interventions in which treatment involves multiple counseling 

sessions, including quitlines). In addition to offering intensive treatments, 

specialists sometimes conduct research on tobacco dependence and its 

treatment. 

As noted above, substantial evidence shows that intensive interventions 

produce higher success rates than do less intensive interventions. In addition, the tobacco dependence interventions offered by specialists represent 

an important treatment resource for patients even if they received tobacco 

dependence treatment from their own clinician.
Treating Tobacco Use and Dependence: 2008 Update

64

The advent of state tobacco quitlines available through a national network 

at 1-800-QUIT-NOW (1-800-784-8669) means that intensive, specialistdelivered interventions are now available to smokers on an unprecedented 

basis. In addition to providing their own clinical tobacco dependence 

interventions, clinicians and health systems can take advantage of this 

availability by implementing systems that regularly refer patients to quitlines either directly or using fax referrals (e.g., via “fax-to-quit” referral 

procedures).195-199

Specialists also may contribute to tobacco control efforts through activities 

such as the following:

• Serving as a resource to nonspecialists who offer tobacco dependence 

services as part of general health care delivery. This might include 

training nonspecialists in counseling strategies, providing consultation 

on difficult cases or for inpatients, and providing specialized assessment services for high-risk populations.

• Developing, evaluating, and implementing changes in office/clinic procedures that increase the rates at which tobacco users are identified and 

treated.200

• Conducting evaluation research to determine the effectiveness of ongoing tobacco dependence treatment activities in relevant institutional 

settings.

• Developing and evaluating innovative treatment strategies that may 

increase the effectiveness and utilization of tobacco dependence treatments.

Strategies for Intensive Tobacco Dependence 

Intervention

Table 4.1 highlights Guideline findings based on meta-analyses and Panel 

opinion (see Chapters 6 and 7) that are particularly relevant to the implementation of intensive treatment programs. The findings in Table 4.1 support recommendations for components of an intensive intervention (Table 

4.2). Of course, implementation of this strategy depends on factors such as 

resource availability and time constraints.
Intensive Interventions for Tobacco Use and Dependence

65

Table 4.1. Findings relevant to intensive interventions

Intensive counseling is especially effective. There is a strong dose-response relation 

between counseling intensity and quitting success. In general, the more intense the 

treatment intervention, the greater the rate of abstinence. Treatments may be made 

more intense by increasing (a) the length of individual treatment sessions and (b) the 

number of treatment sessions.

Many different types of providers (e.g., physicians, nurses, dentists, psychologists, 

social workers, cessation counselors, pharmacists) are effective at increasing quit rates; 

involving multiple types of providers can enhance abstinence rates.

Individual, group, and telephone counseling are effective tobacco use treatment 

formats.

Particular types of counseling strategies are especially effective. Practical counseling 

(problemsolving/skills-training approaches) and the provision of intratreatment social 

support are associated with significant increases in abstinence rates.

Medications such as bupropion SR, nicotine replacement therapies, and varenicline 

consistently increase abstinence rates. Therefore, their use should be encouraged for 

all smokers except in the presence of contraindications or for specific populations for 

which there is insufficient evidence of effectiveness (i.e., pregnant women, smokeless 

tobacco users, light smokers, and adolescents). In some instances, combinations of 

medications may be appropriate. In addition, combining counseling and medication 

increases abstinence rates.

Tobacco dependence treatments are effective across diverse populations (e.g., populations varying in gender, age, and race/ethnicity).

Table 4.2. Components of an intensive tobacco dependence intervention

Assessment Assessments should determine whether tobacco users are 

willing to make a quit attempt using an intensive treatment 

program. Other assessments can provide information useful 

in counseling (e.g., stress level, dependence; see Chapter 6A, 

Specialized Assessment).

Program clinicians Multiple types of clinicians are effective and should be used. 

One counseling strategy would be to have a medical/health 

care clinician deliver a strong message to quit and information 

about health risks and benefits, and recommend and prescribe 

medications recommended in this Guideline update. Nonmedical clinicians could then deliver additional counseling interventions.

Program intensity There is evidence of a strong dose-response relation; therefore, 

when possible, the intensity of the program should be:

Session length – longer than 10 minutes

Number of sessions – 4 or more
Treating Tobacco Use and Dependence: 2008 Update

66

Program format Either individual or group counseling may be used. Telephone 

counseling also is effective and can supplement treatments 

provided in the clinical setting. Use of self-help materials and 

cessation Web sites is optional. Followup interventions should 

be scheduled (see Chapter 6B).

Type of counseling 

and behavioral

therapies

Counseling should include practical counseling (problemsolving/skills training) (see Table 6.19) and intratreatment social 

support (see Table 6.20).

Medication Every smoker should be offered medications endorsed in this 

Guideline, except when contraindicated or for specific populations for which there is insufficient evidence of effectiveness 

(i.e., pregnant women, smokeless tobacco users, light smokers, 

and adolescents; see Table 3.2 for clinical guidelines and Tables 

3.3–3.11 for specific instructions and precautions). The clinician 

should explain how medications increase smoking cessation 

success and reduce withdrawal symptoms. The first-line medications include: bupropion SR, nicotine gum, nicotine inhaler, 

nicotine lozenge, nicotine nasal spray, nicotine patch, and 

varenicline. Certain combinations of cessation medications also 

are effective. Combining counseling and medication increases 

abstinence rates.

Population Intensive intervention programs may be used with all tobacco 

users willing to participate in such efforts. 

Table 4.2. Components of an intensive tobacco dependence intervention 

(continued)
67

 Chapter 5 Systems Interventions—

Importance to Health Care 

Administrators, Insurers, 

and Purchasers

Background 

Efforts to integrate tobacco intervention into the delivery of health care 

require the active involvement of clinicians, health care systems, insurers, 

and purchasers of health insurance. Such integration represents an opportunity to increase rates of delivering tobacco dependence treatments, quit 

attempts, and successful smoking cessation.201

In contrast to strategies that target only the clinician or the tobacco user, 

systems strategies are intended to ensure that tobacco use is systematically assessed and treated at every clinical encounter. Importantly, these 

strategies are designed to work synergistically with clinician- and patientfocused interventions, ultimately resulting in informed clinicians and patients interacting in a seamless way that facilitates the treatment of tobacco 

dependence.202-204

Several considerations argue for the adoption of systems-level tobacco 

intervention efforts. First, such strategies have the potential to substantially 

improve population abstinence rates. Levy et al. estimated that, over time, 

widespread implementation of such strategies could produce a 2 percent 

to 3.5 percent reduction in smoking prevalence rates.205 Second, despite 

recent progress in this area, many clinicians have yet to use evidencebased interventions consistently with their patients who use tobacco.23,48,51

Some evidence indicates that institutional or systems support (e.g., 

adequate clinician training or automated smoker identification systems) 

improves the rates of clinical interventions.206-208 Finally, agents such as 

administrators, insurers, employers, purchasers, and health care delivery 

organizations have the potential to craft and implement supportive 

systems, policies, and environmental prompts that can facilitate the 

delivery of tobacco dependence treatment for millions of Americans. 

For example, managed care organizations and other insurers influence 
Treating Tobacco Use and Dependence: 2008 Update

68

medical care through formularies, performance feedback to clinicians, 

specific coverage criteria, and marketing approaches that prompt patient 

demand for particular services.139,209 Purchasers also have begun to use 

tobacco measures in pay-for-performance initiatives in which managed 

care organizations, clinics, and individual physicians receive additional 

reimbursement by achieving specific tobacco treatment-related goals. 

Indeed, research clearly shows that systems-level changes can reduce 

smoking prevalence among enrollees of managed health care plans.210-212

Unfortunately, the potential benefits of a collaborative partnership among 

health care organizations, insurers, employers, and purchasers have not 

been fully realized. For example, treatments for tobacco use (both medication and counseling) are not provided consistently as paid services for subscribers of health insurance packages.213-215 Although substantial progress 

has been made since the publication of the first Guideline in 1996,1,216-218

neither private insurers nor state Medicaid programs consistently provide 

comprehensive coverage of evidence-based tobacco interventions.206,214,219

Findings such as these resulted in the Healthy People 2010 objective:

Increase insurance coverage of evidence-based treatment for nicotine 

dependency to 100 percent.220

In sum, without supportive systems, policies, insurance coverage, and 

environmental prompts, the individual clinician likely will not assess and 

treat tobacco use consistently. Therefore, just as clinicians must assume 

responsibility to treat their patients for tobacco use, so must health care 

administrators, insurers, and purchasers assume responsibility to craft policies, provide resources, and display leadership that results in a health care 

system that delivers consistent and effective tobacco use treatment.

Cost-Effectiveness of Tobacco Use Treatments

Tobacco use treatments are not only clinically effective, but are costeffective as well. Tobacco use treatments, ranging from clinician advice to 

medication to specialist-delivered intensive programs, are cost-effective in 

relation to other medical interventions such as treatment of hypertension 

and hyperlipidemia and to other preventive interventions such as periodic 

mammography.194,221-224 In fact, tobacco use treatment has been referred 

to as the “gold standard” of health care cost-effectiveness.225 Tobacco use 

treatment remains highly cost-effective, even though a single application 
Systems Interventions 

69

of any effective treatment for tobacco dependence may produce sustained 

abstinence in only a minority of smokers. Finally, evidence-based tobacco 

dependence interventions produce a favorable return on investment from 

the perspective of both the employer and health plan due to reduced health 

care consumption and costs.226-228 The cost-effectiveness of Guideline recommendations for tobacco use treatment is addressed in detail in Chapter 6.

Recommendations for Health Care Administrators, Insurers, and Purchasers

Health care delivery administrators, insurers, and purchasers can promote 

the treatment of tobacco dependence through a systems approach. Purchasers (often business entities or other employers, State or Federal units 

of government, or other consortia that purchase health care benefits for 

a group of individuals) should make tobacco assessment and coverage of 

treatment a contractual obligation of the health care insurers and/or clinicians who provide services to them. In addition to improving the health of 

their employees or subscribers, providing coverage for tobacco dependence 

treatment will result in lower rates of absenteeism229,230 and lower utilization of health care resources.229,231 Health care administrators and insurers 

should provide clinicians with assistance to ensure that institutional changes 

promoting tobacco dependence treatment are implemented universally 

and systematically. Various institutional policies would facilitate these 

interventions, including:

•	 Implementing a tobacco user identification system in every clinic

(Systems Strategy 1).

•	 Providing adequate training, resources, and feedback to ensure that

providers consistently deliver effective treatments (Systems Strategy 2).

•	 Dedicating staff to provide tobacco dependence treatment and assessing

the delivery of this treatment in staff performance evaluations (Systems 

Strategy 3).

•	 Promoting hospital policies that support and provide tobacco

dependence services (Systems Strategy 4).
Treating Tobacco Use and Dependence: 2008 Update

70

•	 Including tobacco dependence treatments (both counseling and medication) identified as effective in this Guideline as paid or covered services 

for all subscribers or members of health insurance packages (Systems 

Strategy 5).

These strategies are based on the evidence described in Chapter 6, as well 

as on Panel opinion.

Strategies for Health Care Administrators, 

Insurers, and Purchasers

Systems Strategy 1. Implement a tobacco user identification system in every clinic

Action Strategies for implementation

Implement an 

office-wide 

system that ensures that for 

every patient 

at every clinic 

visit, tobacco 

use status is 

queried and 

documented.

Office system change:

Expand the vital signs to include tobacco use, or implement an alternative universal identification system.

Responsible staff:

Nurse, medical assistant, receptionist, or other individual already responsible for recording the vital signs. These staff must be instructed 

regarding the importance of this activity and serve as nonsmoking 

role models.

Frequency of utilization:

Every visit for every patient, regardless of the reason for the visit.a

System implementation steps:

Routine smoker identification can be achieved by modifying electronic medical record data collection fields or progress notes in paper 

charts to include tobacco use status as one of the vital signs.

VITAL SIGNS

Blood Pressure: ______________________

Pulse: _______ Weight: _________

Temperature: ________________________

Respiratory Rate: _____________________

Tobacco Use (circle one): Current Former Never

a Repeated assessment is not necessary in the case of the adult who has never used tobacco or who 

has not used tobacco for many years, and for whom this information is clearly documented in the 

medical record.
Systems Interventions 

71

Systems Strategy 2. Provide education, resources, and feedback to promote 

provider intervention

Action Strategies for implementation

Health care systems 

should ensure that 

clinicians have sufficient training to

treat tobacco dependence, clinicians

and patients have resources, and clinicians 

are given feedback 

about their tobacco 

dependence treatment practices.

Educate all staff. On a regular basis, offer training (e.g., lectures, 

workshops, inservices) on tobacco dependence treatments, 

and provide continuing education (CE) credits and/or other 

incentives for participation.

Provide resources such as ensuring ready access to tobacco 

quitlines (e.g., 1-800-Quit-Now) and other community 

resources, self-help materials, and information about effective 

tobacco use medications (e.g., establish a clinic fax-to-quit 

service, place medication information sheets in examination 

rooms).

Report the provision of tobacco dependence interventions on 

report cards or evaluative standards for health care organizations, insurers, accreditation organizations, and physician 

group practices (e.g., HEDIS, The Joint Commission, and Physician Consortium for Performance Improvement).

Provide feedback to clinicians about their performance, drawing on data from chart audits, electronic medical records, and 

computerized patient databases. Evaluate the degree to which 

clinicians are identifying, documenting, and treating patients 

who use tobacco.

Systems Strategy 3. Dedicate staff to provide tobacco dependence treatment, and 

assess the delivery of this treatment in staff performance evaluations

Action Strategies for implementation

Clinical sites should 

communicate to all 

staff the importance 

of intervening with 

tobacco users and 

should designate 

a staff person (e.g., 

nurse, medical assistant, or other clinician) to coordinate 

tobacco dependence 

treatments. Nonphysician personnel may 

serve as effective 

providers of tobacco 

dependence interventions.

Designate a tobacco dependence treatment coordinator for 

every clinical site.

Delineate the responsibilities of the tobacco dependence 

treatment coordinator (e.g., ensuring the systematic identification of smokers, ready access to evidence-based cessation 

treatments [e.g., quitlines], and scheduling of followup visits). 

Communicate to each staff member (e.g., nurse, physician, 

medical assistant, pharmacist, or other clinician) his or her responsibilities in the delivery of tobacco dependence services. 

Incorporate a discussion of these staff responsibilities into 

training of new staff.
Treating Tobacco Use and Dependence: 2008 Update

72

Systems Strategy 4. Promote hospital policies that support and provide inpatient 

tobacco dependence services 

Action Strategies for implementation

Provide tobacco 

dependence treatment to all tobacco 

users admitted to a 

hospital.

Implement a system to identify and document the tobacco use 

status of all hospitalized patients.

Identify a clinician(s) to deliver tobacco dependence inpatient 

consultation services for every hospital and reimburse them for 

delivering these services.

Offer tobacco dependence treatment to all hospitalized patients who use tobacco.

Expand hospital formularies to include FDA-approved tobacco 

dependence medications.

Ensure compliance with The Joint Commission regulations 

mandating that all sections of the hospital be entirely smokefree and that patients receive cessation treatments.

Educate hospital staff that first-line medications may be used 

to reduce nicotine withdrawal symptoms, even if the patient is 

not intending to quit at this time.

Systems Strategy 5. Include tobacco dependence treatments (both counseling and 

medication) identified as effective in this Guideline as paid or covered services for 

all subscribers or members of health insurance packages

Action Strategies for implementation

Provide all insurance 

subscribers, including 

those covered by

managed care organizations (MCOs), workplace health plans, 

Medicaid, Medicare, 

and other government 

insurance programs, 

with comprehensive 

coverage for effective

tobacco dependence 

treatments, including medication and 

counseling.

Cover effective tobacco dependence treatments (counseling 

and medication) as part of the basic benefits package for all 

health insurance packages.

Remove barriers to tobacco treatment benefits (e.g., copays, 

utilization restrictions).

Educate all subscribers and clinicians about the availability 

of covered tobacco dependence treatments (both counseling and medication), and encourage patients to use these 

services.
73

 Chapter 6 Evidence and 

Recommendations

Background

The recommendations summarized in Chapters 2, 3, 4, and 5 are the result 

of a review and analysis of the existing tobacco treatment literature. This 

chapter reports that review and analysis and describes the effectiveness 

of various treatments, assessments, and implementation strategies. This 

chapter also addresses which treatments or assessments are effective, how 

they should be used, and how they should be implemented within a health 

care system.

The Panel identified topics that warranted new analyses for the 2008 

update based on several criteria: they were important, supported by substantial new literature, and/or addressed issues not considered in prior 

Guidelines. The number of topics selected for new analyses was limited by 

the Public Health Service Guideline Update contract parameters. The 2008 

Guideline Update Panel selected 11 topics for new analysis (see Table 1.1), 

based in part on input from tobacco control researchers and practitioners. 

These 11 topics and related categories are represented in Table 6.1. Type of 

outcome analyses varied across the different topics. In most analyses, longterm abstinence (6 months or more) was the outcome measure of interest; 

in others, it was the rate of smoker identification or intervention delivery. 

In addition to these new topics, Table 6.2 lists the topics that previously 

were analyzed for the 1996 and 2000 Guidelines. Importantly, the Guideline Update Panel reviewed all recommendations from the 1996 and 2000 

Guidelines that did not undergo updated meta-analyses. For these prior 

recommendations, the Panel reviewed relevant literature since 1999 to 

determine whether the prior recommendation merited retention, modification, or deletion. See Appendix D for comparison of 2000 and 2008 

Guideline recommendations.

The analyses reported in this chapter almost exclusively addressed treatments for cigarette smoking, as opposed to the use of other forms of 

tobacco, as the small number of studies on the use of noncigarette tobacco 

products, other than smokeless tobacco, precluded their separate analysis. 
Treating Tobacco Use and Dependence: 2008 Update

74

Finally, the Panel attempted to analyze treatment and assessment strategies 

that constitute distinct approaches that exist in current clinical practice.

The Panel chose categories within each analyzed topic according to three 

major criteria. First, some categories reflected generally accepted dimensions or taxonomies. An example of this is the categorical nature of the 

clinician types (physician, psychologist, nurse, and so on). Second, information on the category had to be available in the published literature. Many 

questions of theoretical interest had to be abandoned simply because the 

requisite research literature was not available. Third, the category had to 

occur with sufficient frequency to permit meaningful statistical analysis. 

Therefore, the cutpoints of some continuous variables (e.g., total amount of 

contact time) were determined so there were a sufficient number of studies 

within each analytical category to permit meaningful analysis.

In ideal circumstances, the Panel could evaluate each characteristic by 

consulting randomized controlled trials relevant to the specific categories 

in question. Unfortunately, with the exception of medication interventions, 

very few or no randomized controlled trials are designed to address the 

effects of specific treatment or assessment characteristics of interest. Moreover, treatment characteristics frequently are confounded with one another. 

For example, comparisons among clinicians often are confounded with the 

type of counseling and the format and intensity of the interventions. Therefore, direct, unconfounded comparisons of categories within a particular 

analysis type often were impossible. These characteristics nevertheless were 

analyzed because of their clinical importance, and because it was possible 

to reduce confounding by careful selection of studies and by statistical control of some confounding factors.

Table 6.1. Topics meta-analyzed for the 2008 Guideline update

Characteristics analyzed Categories of those characteristics

Quitline • No quitline intervention

• Use of a proactive quitline

• Use of a proactive quitline in combination with 

medication

• Number of quitline sessions

Combining counseling 

and medication 

• Medication alone

• Counseling alone

• Medication and counseling combined
Evidence and Recommendations

75

Characteristics analyzed Categories of those characteristics

Medications • Placebo medication

• Bupropion SR

• Clonidine

• Nicotine gum

• Nicotine inhaler

• Nicotine lozenge

• Nicotine nasal spray

• Nicotine patch

• Nortriptyline

• Varenicline

• Long-term medication

• Single medication

• Combination of medications

• High-dose nicotine patch

Providing tobacco treatment as a health care 

insurance benefit

• Not providing coverage for tobacco treatment

• Providing services as a covered insurance benefit

Systems features • No intervention

• Clinician training

• Clinician training and reminder systems

Specific populations • Adolescent smokers, pregnant smokers, smokers with 

psychiatric disorders, including substance use disorders 

and smokers with low socioeconomic status/limited 

formal education (see Chapter 7 for description)

Table 6.2. Topics meta-analyzed for the 1996 and 2000 Guidelines and included in 

the 2008 Guideline update (but not re-analyzed)

Characteristics analyzed Categories of those characteristics

Screen for tobacco use • No screening system in place

• Screening system in place

Advice to quit • No advice to quit

• Physician advice to quit

Intensity of person-toperson clinical contact• No person-to-person intervention

• Minimal counseling (longest session ≤ 3 minutes in 

duration)

• Low intensity counseling (longest session > 3 minutes 

and ≤ 10 minutes in duration)

• Higher intensity counseling (longest session > 10 minutes)

• Total amount of contact time

• Number of person-to-person treatment sessions

Table 6.1. Topics meta-analyzed for the 2008 Guideline update (continued)
Treating Tobacco Use and Dependence: 2008 Update

76

Characteristics analyzed Categories of those characteristics

Type of clinician • No clinician

• Self-help materials only

• Nonphysician health care clinician (e.g., psychologist, 

counselor, social worker, nurse, dentist, graduate student, pharmacist, tobacco treatment specialist)

• Physician

• Number of types of clinicians

Formats of psychosocial

intervention

• No contact

• Self-help/self-administered (e.g., pamphlet, audiotape, 

videotape, mailed information, computer program)

• Individual counseling/contact

• Group counseling/contact

• Proactive telephone counseling/contact

• Number of types of formats

Self-help interventions • No self-help intervention

• Number of self-help interventions

• Self-help interventions

Types of counseling and 

behavioral therapies

• No counseling

• No person-to-person intervention or minimal 

counseling

• General: problemsolving/coping skills/relapseprevention/stress-management approach

• Negative affect/depression intervention

• Weight/diet/nutrition intervention

• Extratreatment social support intervention

• Intratreatment social support intervention

• Contingency contracting/instrumental contingencies

• Rapid smoking

• Other aversive smoking techniques

• Cigarette fading/smoking reduction prequit

• Acupuncture

Over-the-counter (OTC)

medication

• Placebo OTC nicotine patch therapy

• OTC nicotine patch therapy

Additional topics that were important and clinically relevant—but did not 

lend themselves to analysis due to a lack of long-term abstinence data—

nevertheless were considered by the Panel through a review of the existing 

literature. The strength of evidence associated with these recommended 

actions for clinical interventions was at the “B” or “C” level (see below), 

reflecting the fact that they are not based primarily on meta-analyses.

Table 6.2. Topics meta-analyzed for the 1996 and 2000 Guidelines and included in 

the 2008 Guideline update (but not re-analyzed) (continued)
Evidence and Recommendations

77

This chapter addresses the treatment and assessment characteristics outlined in Tables 6.1 and 6.2 and is divided into three sections: (1) evidence 

for counseling and psychosocial interventions; (2) evidence for medication 

interventions; and (3) evidence for systems changes. For each topic, background information, clinical recommendations, and the basis for those 

recommendations are provided. As described in Chapter 1, each recommendation was given a strength-of-evidence classification based on the 

criteria shown in Table 6.3. Finally, for many topics, recommendations for 

further research are provided.

Table 6.3. Summary of strength of evidence for recommendations 

Strength-of-evidence 

classification Criteria

Strength of Evidence = A Multiple well-designed randomized clinical trials, directly 

relevant to the recommendation, yielded a consistent 

pattern of findings.

Strength of Evidence = B Some evidence from randomized clinical trials supported 

the recommendation, but the scientific support was not 

optimal. For instance, few randomized trials existed, the 

trials that did exist were somewhat inconsistent, or the 

trials were not directly relevant to the recommendation.

Strength of Evidence = C Reserved for important clinical situations in which the 

Panel achieved consensus on the recommendation in the 

absence of relevant randomized controlled trials.

A. Counseling and Psychosocial Evidence

1. Screening and Assessment

 Screen for Tobacco Use

Recommendation: All patients should be asked if they use tobacco and 

should have their tobacco use status documented on a regular basis. 

Evidence has shown that clinic screening systems, such as expanding the 

vital signs to include tobacco use status or the use of other reminder systems such as chart stickers or computer prompts, significantly increase 

rates of clinician intervention. (Strength of Evidence = A)

The Panel relied on the meta-analyses from the original 1996 Guideline 

to determine the impact of tobacco screening systems. Tobacco screening 
Treating Tobacco Use and Dependence: 2008 Update

78

systems were evaluated in terms of their impact on two outcomes: the rate 

of tobacco treatment by clinicians, and the rate of cessation by patients 

who smoke. 

Identifying Tobacco Users: Impact on Clinical Intervention. Nine studies met 

the selection criteria and were meta-analyzed as part of the 1996 Guideline 

to assess the impact of screening systems on the rate of smoking cessation 

intervention by clinicians. The results of this meta-analysis are shown in 

Table 6.4. Implementing clinic systems designed to increase the assessment 

and documentation of tobacco use status markedly increases the rate at 

which clinicians intervene with their patients who smoke.

Table 6.4. Meta-analysis (1996): Impact of having a tobacco use status identification system in place on rates of clinician intervention with their patients who 

smoke (n = 9 studies)a

Screening system Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated rate of clinician 

intervention (95% C.I.)

No screening

system in place to

identify smoking

status (reference

group)

9 1.0 38.5

Screening system

in place to identify

smoking status

9 3.1 (2.2–4.2) 65.6 (58.3–72.6)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Identifying Tobacco Users: Impact on Tobacco Cessation. Three studies met 

the selection criteria and were meta-analyzed as part of the 1996 Guideline to assess the impact of identifying smokers on actual rates of smoking 

cessation. The results of this meta-analysis are shown in Table 6.5. These 

results, combined with the results from Table 6.4, show that having a clinic 

system in place that identifies smokers increases rates of clinician intervention but does not, by itself, produce significantly higher rates of smoking 

cessation. 

Strategy A1 (see Chapter 3A) and Systems Strategy 1 (see Chapter 5) detail 

an approach for including tobacco use status as a vital sign with systematic prompts and reminders. Although the data assessing this intervention were gathered exclusively from cigarette smokers, the Panel believed 

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta
Evidence and Recommendations

79

that these results are generalizable to all tobacco users. This approach is 

designed to produce consistent assessment and documentation of tobacco 

use. Evidence from controlled trials shows that this approach increases the 

probability that tobacco use is assessed and documented consistently.54,232

However, documenting smoking status is not by itself sufficient to promote 

treatment by clinicians.233 Systems changes beyond smoker identification 

strategies are likely to be needed to increase rates of cessation advice and 

intervention.139,234-237

Table 6.5. Meta-analysis (1996): Impact of having a tobacco use status identification 

system in place on abstinence rates among patients who smoke (n = 3 studies)a

Screening system Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate 

(95% C.I.)

No screening

system in place to

identify smoking

status (reference

group)

3 1.0 3.1

Screening system

in place to identify

smoking status

3 2.0 (0.8–4.8) 6.4 (1.3–11.6)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

 Specialized Assessment

Recommendation: Once a tobacco user is identified and advised to quit, 

the clinician should assess the patient’s willingness to quit at this time. 

(Strength of Evidence = C)

If the patient is willing to make a quit attempt at this time, 

interventions identified as effective in this Guideline should be 

provided. (See Chapters 3A and 4.)

If the patient is unwilling to quit at this time, an intervention 

designed to increase future quit attempts should be provided. 

(See Chapter 3B.)

Recommendation: Tobacco dependence treatment is effective and should 

be delivered even if specialized assessments are not used or available. 

(Strength of Evidence = A)

ed in this meta-analysis.
Treating Tobacco Use and Dependence: 2008 Update

80

Every individual entering a health care setting should receive an assessment that determines his or her tobacco use status and interest in quitting. 

The patient should be asked, “Are you willing to make a quit attempt at 

this time?” Such an assessment (willing or unwilling) is a necessary first 

step in treatment. In addition, every patient should be assessed for physical 

or medical conditions that may affect the use of planned treatments (e.g., 

medication). 

The clinician also may want to perform specialized assessments of individual and environmental attributes that provide information for tailoring 

treatment and that predict quitting success. Specialized assessments refer 

to the use of formal instruments (e.g., questionnaires, clinical interviews, 

or physiologic indices such as carbon monoxide, serum nicotine/cotinine 

levels, and/or pulmonary function) that may be associated with cessation 

outcome (in addition, the reader may find other assessments relevant to 

medication use and specific populations when selecting treatment). Some 

of the variables targeted by specialized assessments that predict quitting 

success are listed in Table 6.6.

Several considerations should be kept in mind regarding the use of 

specialized assessments. First, there is little consistent evidence that 

a smoker’s status on a specialized assessment is useful for treatment 

matching. The one exception is that persons who are highly nicotine 

dependent may benefit more from higher nicotine gum or lozenge doses 

(see Medication Evidence; Section B of Chapter 6). More importantly, the 

Panel found that, regardless of their standing on specialized assessments, 

all smokers have the potential to benefit from tobacco dependence 

treatments. Therefore, delivery of tobacco dependence treatments should 

not depend on the use of specialized assessments. Finally, tailored 

interventions based on specialized assessments do not consistently 

produce higher long-term quit rates than do nontailored interventions of 

equal intensity. Some promising studies exist, however, that suggest that 

individualizing self-help materials may be beneficial (see Individually 

Tailored and Stepped-Care Interventions, page 92).238-245 In addition, 

the Panel recognizes that some effective interventions, such as general 

problemsolving (see Types of Counseling and Behavioral Therapies, on 

page 96), entail treatment tailoring based on a systematic assessment that 

occurs as an integral part of treatment.
Evidence and Recommendations

81

Table 6.6. Variables associated with higher or lower abstinence rates

Variables associated with higher abstinence rates

Variable Examples

High motivation

Ready to change

Moderate to high self-efficacy

Supportive social network

Tobacco user reports a strong motivation to quit.

Tobacco user is ready to quit within a 1-month 

period.

Tobacco user is confident in his or her ability to quit.

A smoke-free workplace and home; friends who do 

not smoke in the quitter‘s presence.

Variables associated with lower abstinence rates

Variable Examples

High nicotine dependence

Psychiatric comorbidity and 

substance use

High stress level

Exposure to other smokers

Tobacco user smokes heavily ( ≥ 20 cigarettes/day), 

and/or has first cigarette of the day within 30 minutes after waking in the morning.

Tobacco user currently has elevated depressive 

symptoms, active alcohol abuse, or schizophrenia. 

Stressful life circumstances and/or recent or anticipated major life changes (e.g., divorce, job change).

Other smokers in the household.

The existing evidence suggests that treatment can be effective despite the 

presence of risk factors for relapse (e.g., high nicotine dependence, other 

smokers in the home), but abstinence rates in smokers with these characteristics tend to be lower than rates in those without these characteristics.246-248

 Future Research

The following topics regarding specialized assessment require additional 

research:

•	Whether treatment adjustment based on specialized assessments can

improve long-term abstinence rates
Treating Tobacco Use and Dependence: 2008 Update

82

•	Whether working to change the social network can improve abstinence

rates (e.g., intervening with other smokers in the household to change 

their smoking patterns, teaching quitting support, or encouraging a 

smokefree home)

•	 Disparities in screening and assessment in specific populations

2. Treatment Structure and Intensity

 Advice To Quit Smoking

Recommendation: All physicians should strongly advise every patient 

who smokes to quit because evidence shows that physician advice to 

quit smoking increases abstinence rates. (Strength of Evidence = A)

For these recommendations, the 2008 Guideline Panel relied on metaanalyses performed for the 1996 Guideline. Seven studies were included 

in the 1996 meta-analysis of the effectiveness of physician advice to 

quit smoking. In the studies used in this analysis, the modal length of 

clinician intervention was 3 minutes or less. Two studies in this analysis 

used interventions lasting about 5 minutes. Results of the meta-analysis 

on physician advice are shown in Table 6.7. This analysis shows that brief 

physician advice significantly increases long-term smoking abstinence 

rates. These results were also supported by a more recent, independent 

meta-analysis.56

Advice by physicians was examined in the Table 6.7 meta-analysis from the 

1996 Guideline; there were too few studies to examine advice delivered by 

any other type of clinician, although one study found that advice to quit 

from health care providers in general did significantly increase quit rates.249

The analysis for total amount of contact time (see Table 6.9) indicates 

that minimal counseling (advice) delivered by a variety of clinician types 

increases long-term abstinence rates. Also, studies have shown that dentists 

and dental hygienists can be effective in assessing and advising smokeless/

spit tobacco users to quit250 (see Chapter 7). Given the large number of 

smokers who visit a clinician each year, the potential public health impact 

of universal advice to quit is substantial.56
Evidence and Recommendations

83

Table 6.7. Meta-analysis (1996): Effectiveness of and estimated abstinence rates 

for advice to quit by a physician (n = 7 studies)a

Advice Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

No advice to

quit (reference

group)

9 1.0 7.9

Physician

advice to quit 10 1.3 (1.1–1.6) 10.2 (8.5–12.0)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

 Future Research

The following topics regarding advice to quit require additional research:

•	 Effectiveness of advice to quit smoking given by clinicians other than

physicians (e.g., nurses, nurse practitioners, pharmacists, dentists, dental hygienists, tobacco treatment specialists, physician’s assistants)

•	 Cumulative effectiveness of combined advice from physicians and

other types of clinicians

 Intensity of Clinical Interventions

Recommendation: Minimal interventions lasting less than 3 minutes 

increase overall tobacco abstinence rates. Every tobacco user should 

be offered at least a minimal intervention, whether or not he or she is 

referred to an intensive intervention. (Strength of Evidence = A) 

Recommendation: There is a strong dose-response relation between the 

session length of person-to-person contact and successful treatment 

outcomes. Intensive interventions are more effective than less intensive 

interventions and should be used whenever possible. (Strength of Evidence = A)

Recommendation: Person-to-person treatment delivered for four or 

more sessions appears especially effective in increasing abstinence rates. 

Therefore, if feasible, clinicians should strive to meet four or more times 

with individuals quitting tobacco use. (Strength of Evidence = A)
Treating Tobacco Use and Dependence: 2008 Update

84

These recommendations are supported by three separate meta-analyses 

conducted for the 2000 Guideline: one involving session length, one 

involving total amount of contact time, and one involving the number of 

sessions.

Table 6.8. Meta-analysis (2000): Effectiveness of and estimated abstinence rates 

for various intensity levels of session length (n = 43 studies)a

Level of contact Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

No contact 30 1.0 10.9

Minimal counseling 

(< 3 minutes) 19 1.3 (1.01–1.6) 13.4 (10.9–16.1)

Low-intensity 

counseling

(3-10 minutes) 16 1.6 (1.2–2.0) 16.0 (12.8–19.2)

Higher intensity 

counseling 

(> 10 minutes) 55 2.3 (2.0–2.7) 22.1 (19.4–24.7)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Session Length. Forty-three studies met selection criteria for comparison 

across various session lengths. Whenever possible, session length was 

categorized based on the maximum amount of time the clinician spent 

with a smoker addressing tobacco dependence in a single contact. Minimal 

counseling interventions were defined as 3 minutes or less, low-intensity 

counseling was defined as greater than 3 minutes to 10 minutes, and higher 

intensity counseling interventions were defined as greater than 10 minutes. 

Interventions could involve multiple patient-clinician contacts, with the 

session length determined for coding purposes as the length of time of the 

longest session. These levels of person-to-person contact were compared 

with a no-contact reference group involving study conditions in which 

subjects received no person-to-person contact (e.g., self-help-only conditions). There is a dose-response relation between session length and abstinence rates. As Table 6.8 shows, all three session lengths (minimal counseling, low-intensity counseling, and higher intensity counseling) significantly 

increased abstinence rates over those produced by no-contact conditions. 

However, there was a clear trend for abstinence rates to increase across 

these session lengths, with higher intensity counseling producing the highest rates.
Evidence and Recommendations

85

Total Amount of Contact Time. Thirty-five studies met the selection criteria 

for the analysis assessing the impact of total contact time. The amount of 

contact time was calculated from the text as the total time accumulated 

(the number of sessions multiplied by the session length). When the exact 

time was not known for minimal and low-intensity interventions, they 

were assigned median lengths of 2 and 6.5 minutes, respectively. The total 

amount of contact time was then categorized as no-contact, 1–3 minutes, 4–30 minutes, 31–90 minutes, 91–300 minutes, and greater than 

300 minutes. As Table 6.9 shows, any contact time significantly increased 

abstinence rates over those produced by no contact. However, there was a 

clear trend for abstinence rates to increase across contact time, up to the 

90-minute mark. There was no evidence that more than 90 minutes of total 

contact time substantially increases abstinence rates.

Table 6.9. Meta-analysis (2000): Effectiveness of and estimated abstinence rates 

for total amount of contact time (n = 35 studies)a

Total amount of

contact time

Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

No minutes 16 1.0 11.0

1–3 minutes 12 1.4 (1.1–1.8) 14.4 (11.3–17.5)

4–30 minutes 20 1.9 (1.5–2.3) 18.8 (15.6–22.0)

31–90 minutes 16 3.0 (2.3–3.8) 26.5 (21.5–31.4)

91–300 minutes 16 3.2 (2.3–4.6) 28.4 (21.3–35.5)

> 300 minutes 15 2.8 (2.0–3.9) 25.5 (19.2–31.7)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Number of Sessions. Forty-six studies involving at least some person-toperson contact met selection criteria for the analysis addressing the impact 

of number of treatment sessions. Zero or one session was used as the reference group. As shown in Table 6.10, multiple treatment sessions increase 

smoking abstinence rates over those produced by zero or one session. The 

evidence suggests a dose-response relation between number of sessions 

and treatment effectiveness.

It is important to note that although the use of more intensive interventions (i.e., longer sessions, more sessions) may produce enhanced abstinence rates, these interventions may have limited reach (affect fewer smokers) and may not be feasible in some primary care settings. For instance, 
Treating Tobacco Use and Dependence: 2008 Update

86

not all smokers are interested in participating in an intensive intervention, 

and not all smokers may have access to or be able to afford services that can 

provide intensive interventions. Finally, the clinician can link the patient to 

additional treatment options, such as quitlines or other intensive cessation 

treatment programs, to provide additional person-to-person treatment.

 Future Research

The following topics regarding intensity of person-to-person contact 

require additional research:

•	 Effects of treatment duration, timing, and spacing of sessions (i.e., the

number of days or weeks over which treatment is spread). For instance, 

does front loading sessions (having the majority of the sessions during 

the first few weeks of a quit attempt) or spacing sessions throughout 

the quit attempt yield better long-term abstinence rates?

•	Methods to increase the appeal and utilization of intensive treatments

•	 Effectiveness of intensive inpatient treatment programs

Table 6.10. Meta-analysis (2000): Effectiveness of and estimated abstinence rates 

for number of person-to-person treatment sessions (n = 46 studies)a

Number of sessions Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

0–1 session 43 1.0 12.4

2–3 sessions 17 1.4 (1.1–1.7) 16.3 (13.7–19.0)

4–8 sessions 23 1.9 (1.6–2.2) 20.9 (18.1–23.6)

> 8 sessions 51 2.3 (2.1–3.0) 24.7 (21.0–28.4)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.
Evidence and Recommendations

87

 Type of Clinician

Recommendation: Treatment delivered by a variety of clinician types 

increases abstinence rates. Therefore, all clinicians should provide 

smoking cessation interventions. (Strength of Evidence = A)

Recommendation: Treatments delivered by multiple types of clinicians 

are more effective than interventions delivered by a single type of clinician. Therefore, the delivery of interventions by more than one type of 

clinician is encouraged. (Strength of Evidence = C)

Clinician Types. Twenty-nine studies met selection criteria for the 

2000 meta-analysis examining the effectiveness of various types of 

clinicians providing tobacco use treatment. These analyses compared the 

effectiveness of interventions delivered by different types of clinicians 

with interventions in which there were no clinicians (e.g., when there 

was no intervention or the intervention consisted of self-help materials 

only). Tobacco use treatments delivered by any single type of health care 

provider, such as a physician or other clinician (e.g., nurse, psychologist, 

dentist, or counselor), or by multiple clinicians, increase abstinence rates 

relative to interventions in which there is no clinician (e.g., self-help 

interventions). None of the studies in these analyses involved medication, 

but they did involve psychosocial intervention, principally counseling. 

Results are shown in Table 6.11. Results suggest that physicians and other 

clinicians are similarly effective in delivering tobacco cessation counseling. 

New research reviewed since the 2000 Guideline suggests that trained peer 

counselors also may be effective.251-253

Number of Clinician Types. Thirty-seven studies met selection criteria for 

the 2000 analysis examining the effectiveness of multiple clinicians used in 

smoking cessation interventions. “Multiple clinicians” refers to the number 

of different types of clinicians (if a nurse and a physician each delivered 

parts of an intervention, two types of clinicians would be involved). Tobacco use treatments delivered by two or more types of clinicians increase 

abstinence rates relative to those produced by interventions in which there 

is no clinician (Table 6.12). However, the number of clinician types is confounded with treatment intensity. For instance, if an individual meets with 

a physician for a medication consultation and then talks to a health educator about the quit plan, that is two clinicians and two sessions. The number 

of contacts may be more important than the number of clinicians providing treatment.
Treating Tobacco Use and Dependence: 2008 Update

88

Table 6.11. Meta-analysis (2000): Effectiveness of and estimated abstinence rates 

for interventions delivered by different types of clinicians (n = 29 studies)a

Type of clinician Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

No clinician 16 1.0 10.2

Self-help 47 1.1 (0.9–1.3) 10.9 (9.1–12.7)

Nonphysician 

clinician 39 1.7 (1.3–2.1) 15.8 (12.8–18.8)

Physician clinician 11 2.2 (1.5–3.2) 19.9 (13.7–26.2)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Table 6.12. Meta-analysis (2000): Effectiveness of and estimated abstinence rates 

for interventions delivered by various numbers of clinician types (n = 37 studies)a

Number of clinician typesNumber of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

No clinician 30 1.0 10.8

One clinician type 50 1.8 (1.5–2.2) 18.3 (15.4–21.1)

Two clinician types 16 2.5 (1.9–3.4) 23.6 (18.4–28.7)

Three or more clinician types 7 2.4 (2.1–2.9) 23.0 (20.0–25.9)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

 Future Research

The following topics regarding type of clinician require additional research:

•	 Effectiveness of specific types of clinicians (e.g., quitline counselors,

trained peer counselors, nurses, physician assistants, pharmacists, 

social workers)

•	 Relative effectiveness of various numbers and types of clinicians, with

the intensity of the intervention held constant

 Formats of Psychosocial Treatments

Recommendation: Proactive telephone counseling, group counseling, 

and individual counseling formats are effective and should be used in 

smoking cessation interventions. (Strength of Evidence = A)
Evidence and Recommendations

89

Recommendation: Smoking cessation interventions that are delivered 

in multiple formats increase abstinence rates and should be encouraged. 

(Strength of Evidence = A)

Recommendation: Tailored materials, both print and Web-based, appear to be effective in helping people quit. Therefore, clinicians may 

choose to provide tailored self-help materials to their patients who want 

to quit. (Strength of Evidence = B)

Format Types. Overall format type (delivery mode) recommendations rest 

on the 2000 Guideline meta-analysis, although new focused analyses of 

proactive quitlines were conducted for the 2008 update. Fifty-eight studies 

met selection criteria and were included in the 2000 meta-analysis comparing different types of formats (see Table 6.13). Tobacco use treatment 

delivered by means of proactive telephone counseling/contact (quitlines, 

call-back counseling), individual counseling, and group counseling/contact 

all increase abstinence rates relative to no intervention.

Self-Help. The 2000 format meta-analysis also evaluated the effectiveness 

of self-help interventions (e.g., pamphlets/booklets/mailings/manuals, 

videotapes, audiotapes, referrals to 12-step programs, reactive telephone 

hotlines/helplines [see Glossary], computer programs/Internet, and lists of 

community programs). Interventions delivered by means of widely varied 

self-help materials (whether as stand-alone treatments or as adjuvants) 

appear to increase abstinence rates relative to no intervention in this particular analysis. However, the effect of self-help was weak and typically not 

significant across analyses conducted for the 2000 Guideline (see Tables 

6.13 and 6.15). 

Number of Formats. Fifty-four studies met selection criteria and were 

included in the 2000 meta-analysis comparing the number of format types 

used for tobacco use treatment. The self-help treatments included in this 

analysis occurred either by themselves or in addition to other treatments. 

Tobacco use treatment that used three or four format types was especially 

effective. Results of this analysis are shown in Table 6.14.

Self-Help: Focused Analyses. Because the format meta-analysis revealed 

self-help to be of marginal effectiveness, another analysis was undertaken 

in 2000 to provide additional, focused information on self-help. Studies 

were accepted for the 2000 analysis if the presence of self-help materi-
Treating Tobacco Use and Dependence: 2008 Update

90

als constituted the sole difference in treatment arms. In the main format 

analysis, some treatment arms differed on factors other than self-help per 

se (e.g., intensity of counseling). The treatments that accompanied self-help 

material in the focused analysis ranged from no advice or counseling to 

intensive counseling. The results of this analysis were comparable to those 

in the larger format analysis (i.e., self-help was of marginal effectiveness). 

For the 2000 Guideline analysis, 21 studies met selection criteria to evaluate the effectiveness of providing multiple types of self-help interventions 

(e.g., pamphlets, videotapes, audiotapes, and reactive hotlines/helplines). 

The results provide little evidence that the provision of multiple types of 

self-help, when offered without any person-to-person intervention, significantly enhances treatment outcomes (see Table 6.15).

Two final 2000 meta-analyses addressed the impact of self-help brochures 

per se. In one analysis, brochures were used as the only intervention. In the 

other analysis, self-help brochures were used in addition to counseling. In 

neither analysis did self-help significantly boost abstinence rates.

Table 6.13. Meta-analysis (2000): Effectiveness of and estimated abstinence rates 

for various types of formats (n = 58 studies)a

Format Number Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

No format 20 1.0 10.8

Self-help 93 1.2 (1.02–1.3) 12.3 (10.9–13.6)

Proactive telephone 

counseling 26 1.2 (1.1–1.4) 13.1 (11.4–14.8)

Group counseling 52 1.3 (1.1–1.6) 13.9 (11.6–16.1)

Individual counseling 67 1.7 (1.4–2.0) 16.8 (14.7–19.1)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.
Evidence and Recommendations

91

Table 6.14. Meta-analysis (2000): Effectiveness of and estimated abstinence rates 

for number of formats (n = 54 studies)a

Number of formatsb Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

No format 20 1.0 10.8

One format 51 1.5 (1.2–1.8) 15.1 (12.8–17.4)

Two formats 55 1.9 (1.6–2.2) 18.5 (15.8–21.1)

Three or four formats 19 2.5 (2.1–3.0) 23.2 (19.9–26.6)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis. b Formats included self-help, proactive telephone counseling, group, or individual counseling.

Table 6.15. Meta-analysis (2000): Effectiveness of and estimated abstinence rates 

for number of types of self-help (n = 21 studies)a

Factor Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

No self-help 17 1.0 14.3

One type of self-help 27 1.0 (0.9–1.1) 14.4 (12.9–15.9)

Two or more types 10 1.1 (0.9–1.5) 15.7 (12.3–19.2)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Quitlines. Both the substantial growth in quitline research and the 

implementation of a national network of tobacco quitlines (available 

through 1-800-QUIT-NOW) led the 2008 Guideline Panel to identify 

quitline effectiveness as a topic deserving focused meta-analyses. Nine 

studies met selection criteria and were analyzed for the 2008 Guideline 

update comparing the effectiveness of a quitline intervention versus 

minimal or no contact or self-help materials. This differs from the 

2000 meta-analysis (Table 6.13) in that the current analysis focused on 

study arms that used quitline intervention alone rather than telephone 

counseling that may have occurred with other types of interventions. For 

the purpose of this analysis, quitlines are defined as telephone counseling 

in which at least some of the contacts are initiated by the quitline counselor 

to deliver tobacco use interventions, including call-back counseling. 

Quitlines significantly increase abstinence rates compared to minimal or 

no counseling interventions (Table 6.16).254 In a second 2008 meta-analysis 

of quitlines, six studies were analyzed comparing the effect of adding 

quitline counseling to medication versus medication alone. The addition of 

quitline counseling to medication significantly improves abstinence rates 
Treating Tobacco Use and Dependence: 2008 Update

92

compared to medication alone (see Table 6.17). These analyses suggest 

a robust effect of quitline counseling and are consistent with a recent 

independent analysis254 and with the recently released Centers for Disease 

Control and Prevention’s Guide to Community Preventive Services.

92

Table 6.16. Meta-analysis (2008): Effectiveness of and estimated abstinence 

rates for quitline counseling compared to minimal interventions, self-help, or no 

counseling (n = 9 studies)a

Intervention Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

Minimal or no 

counseling or 

self-help 

11 1.0 8.5

Quitline counseling 11 1.6 (1.4–1.8) 12.7 (11.3–14.2)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Table 6.17. Meta-analysis (2008): Effectiveness of and estimated abstinence rates for 

quitline counseling and medication compared to medication alone (n = 6 studies)a

Intervention Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

Medication alone 6 1.0 23.2

Medication and 

quitline counseling 6 1.3 (1.1–1.6) 28.1 (24.5–32.0)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Individually Tailored and Stepped-Care Interventions. Recent research has 

focused on the use of individually tailored materials. Tailored materials 

are those that are designed to address smoker-specific variables, such as 

support sources, recency of quitting, and concerns about quitting. Tailored 

materials can either be print materials, such as letters mailed to patients, 

or Web-based materials such as interactive Web sites.238,242 Some applications of tailoring have been shown to be effective and to have broad 

reach.241,245,255,256 The Panel also considered the use of stepped-care interventions (see Glossary) and concluded that there is not enough evidence to 

recommend a stepped-care approach as a basis for tailoring.257,258 However, 

these approaches warrant future research.
Evidence and Recommendations

93

Computerized Interventions. E-health or Internet interventions have the 

potential to be accessed by a large percentage of the smoking population, 

permit extensive tailoring of content to the tobacco user’s needs or characteristics, and, due to low personnel costs, are likely to be inexpensive to 

deliver. Such interventions may be used as stand-alone or adjuvant treatments. These programs typically collect information from the tobacco 

user and then use algorithms to tailor feedback or recommendations. They 

also typically permit the user to select from various features, including 

extensive information on quitting, tobacco dependence, and related topics. 

Current applications permit multiple iterations of feedback, development 

and monitoring of a quit plan, and proactive e-mail prompts to users.259,260

Optimal features of Web site resources have not yet been identified; some 

sites may be confusing and may not exploit the tailoring potential of this 

medium.261 Clearly, more research is needed to identify their optimal structures, features, and contents.262-265

E-health tobacco interventions generally have yielded positive results. In 

a recent review of the use of these interventions with adult tobacco users, 

Walters et al. found that 7 of 15 studies with adults reported significantly 

improved outcomes over control conditions.259 Hall et al. combined 

computerized individualized feedback designed to motivate smokers using 

principles of the Stages of Change model with six 30-minute sessions of 

counseling and the nicotine patch. This was compared with untailored 

self-help material. Significant improvement due to the more intensive 

treatment was found at 18-month followup.266 Strecher et al. compared a 

multifaceted Web-based intervention (tailored cessation guide based on 

cognitive-behavioral principles, a medication adherence intervention, 

tailored e-mails, and a behavioral support person) in concert with the 

nicotine patch. This was contrasted with the patch alone. Favorable 

outcomes were obtained at 3 months postquit.241 Similar positive effects 

also have been reported for a population study using computer-generated 

reports based on the Stages of Change model267 and a Web site study 

offered in a worksite program.268 A study with adolescents269 reported 

positive results due to access to a complex intervention that comprised 

an interactive computer intervention, clinician advice, brief motivational 

interviewing, and telephonic booster sessions. The control condition was 

information about eating more fruits and vegetables. Null results with 

computerized or computer-tailored interventions also have been obtained 

(see, e.g., Velicer et al.270 and Aveyard et al.271). Moreover, in many of the 

studies yielding positive results, the Web-based intervention is just one 
Treating Tobacco Use and Dependence: 2008 Update

94

element of a complex intervention, or is considerably more intense than 

the comparison intervention. Given the potential reach and low costs of 

such interventions, however, they remain a highly promising delivery 

system for tobacco dependence.

 Future Research

The following topics regarding formats require additional research:

•	Which combinations of formats are most effective

•	 Relative effectiveness of different types of self-help interventions,

including computer-based interventions

•	 Effectiveness of tailoring

•	 Effectiveness of fax-to-quit programs and other programs designed to

increase quitline use

•	 Effective features of Web-based interventions

•	 Effect of computer-delivered interventions as a format versus the effect

of the content of the intervention

•	 Optimal methods to decrease barriers and increase the appeal and use

of effective counseling treatments

 Followup Assessment and Procedures

Recommendation: All patients who receive a tobacco dependence intervention should be assessed for abstinence at the completion of treatment and during subsequent contacts. (1) Abstinent patients should 

have their quitting success acknowledged, and the clinician should offer 

to assist the patient with problems associated with quitting (see Chapter 3C, For the Patient Who Has Recently Quit). (2) Patients who have 

relapsed should be assessed to determine whether they are willing to 

make another quit attempt. (Strength of Evidence = C) 
Evidence and Recommendations

95

If the patient is willing to make another quit attempt, provide or arrange additional treatment (see Chapter 3A, For the Patient Willing 

To Quit). 

If the patient is not willing to try to quit, provide or arrange an intervention designed to increase future quit attempts (see Chapter 3B, For 

the Patient Unwilling To Quit).

All patients should be assessed with respect to their smoking status during followup clinical contacts. In particular, assessments within the first 

week after quitting should be encouraged.272,273 Abstinent patients should 

receive reinforcement for their decision to quit, be congratulated on their 

success at quitting, and be encouraged to remain abstinent (see Chapter 3C, 

Strategy C1). The existing evidence does not show that these steps will 

prevent relapse, but continued involvement on the part of the clinician may 

increase the likelihood that the patient will consult the clinician in later 

quit attempts should they be needed. Clinicians also should inquire about 

and offer to help the patient with potential problems related to quitting 

(see Chapter 3C, Strategy C2), such as significant weight gain or residual 

withdrawal symptoms. 

Patients who have relapsed should again be assessed for their willingness 

to quit. Patients who currently are motivated to make another quit attempt should be encouraged to use a tobacco dependence intervention 

(see Chapter 3A, For the Patient Willing To Quit). Clinicians may wish 

to increase the intensity of psychosocial treatment at this time or refer 

the patient to a tobacco dependence specialist/program for a more intensive treatment if the patient is willing. In addition, medication should be 

offered again to the patient, if appropriate. If the previous quit attempt 

included medication, the clinician should review whether the patient 

used the medication in an effective manner and determine whether the 

medication was helpful. Based on this assessment, the clinician should 

recommend retreatment with the same medication, another medication, 

or a combination of medications (see Tables 6.26–6.28). Patients who have 

relapsed and are unwilling to quit at the current time should receive a brief 

intervention designed to increase future quit attempts (see Chapter 3B). 
Treating Tobacco Use and Dependence: 2008 Update

96

 Future Research

The following topics regarding followup assessment and treatments require 

additional research:

•	 Optimal timing and types of relapse prevention interventions

•	 Effectiveness of various formats for relapse prevention treatments (e.g.,

effectiveness of telephone contacts in reducing the likelihood of relapse 

after a minimal intervention)

3. Treatment Elements

 Types of Counseling and Behavioral Therapies

Recommendation: Two types of counseling and behavioral therapies 

result in higher abstinence rates: (1) providing smokers with practical 

counseling (problemsolving skills/skills training), and (2) providing 

support and encouragement as part of treatment. These types of counseling elements should be included in smoking cessation interventions. 

(Strength of Evidence = B)

Sixty-four studies met selection criteria for meta-analyses in 2000 to examine the effectiveness of interventions using various types of counseling 

and behavioral therapies. The results, shown in Table 6.18, reveal that four 

specific types of counseling and behavioral therapy categories yield statistically significant increases in abstinence rates relative to no-contact (i.e., 

untreated control conditions). These categories are: (1) providing practical 

counseling such as problemsolving/skills training/stress management; 

(2) providing support during a smoker’s direct contact with a clinician 

(intratreatment social support); (3) intervening to increase social support 

in the smoker’s environment (extratreatment social support); and (4) using 

aversive smoking procedures (rapid smoking, rapid puffing, other smoking exposure). A separate analysis was conducted eliminating studies that 

included the use of U.S. Food and Drug Administration (FDA)-approved 

medications. The results of this analysis were substantially similar to the 

main analysis.
Evidence and Recommendations

97

Table 6.18. Meta-analysis (2000): Effectiveness of and estimated abstinence rates 

for various types of counseling and behavioral therapies (n = 64 studies)a

Type of counseling and 

behavioral therapy

Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate 

(95% C.I.)

No counseling/behavioral therapy 35 1.0 11.2

Relaxation/breathing 31 1.0 (0.7–1.3) 10.8 (7.9–13.8)

Contingency contracting 22 1.0 (0.7–1.4) 11.2 (7.8–14.6)

Weight/diet 19 1.0 (0.8–1.3) 11.2 (8.5–14.0)

Cigarette fading 25 1.1 (0.8–1.5) 11.8 (8.4–15.3)

Negative affect 8 1.2 (0.8–1.9) 13.6 (8.7–18.5)

Intratreatment social 

support 50 1.3 (1.1–1.6) 14.4 (12.3–16.5)

Extratreatment social 

support 19 1.5 (1.1–2.1) 16.2 (11.8–20.6)

Practical counseling 

(general problemsolving/skills training)104 1.5 (1.3–1.8) 16.2 (14.0–18.5)

Other aversive smoking 19 1.7 (1.04–2.8) 17.7 (11.2–24.9)

Rapid smoking 19 2.0 (1.1–3.5) 19.9 (11.2–29.0)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

The 2008 Guideline Panel decided not to recommend extratreatment social 

support in the current Guideline update. This change was based on recent 

literature on extratreatment social support that does not show a strong 

effect for helping smokers identify and utilize support outside of the treatment relationship.274-276 Aversive smoking was recommended in the 2000 

Guideline. However, new studies that have been conducted since the 2000 

Guideline, including a Cochrane Review, cast doubt on the effectiveness of 

aversive smoking.277 Because of this and the side effects of this treatment, 

the Guideline Panel decided not to recommend the use of aversive smoking therapy in the 2008 update. 

The strength of evidence for the 2008 Guideline update recommendations 

regarding practical counseling and intratreatment social support did not 

warrant an “A” rating for several reasons. First, the evidence reviewed indicated that tobacco use treatments rarely used a particular type of counsel-
Treating Tobacco Use and Dependence: 2008 Update

98

ing or behavioral therapy in isolation. Second, various types of counseling 

and behavioral therapies tended to be correlated with other treatment characteristics. For instance, some types of counseling and behavioral therapies 

were more likely to be delivered using a greater number of sessions across 

longer time periods. Third, all of these types of counseling and behavioral 

therapies were compared with no-contact/control conditions. Therefore, 

the control conditions in this meta-analysis did not control for nonspecific 

or placebo effects of treatment. This further restricted the ability to attribute effectiveness to particular types of counseling and behavioral therapies per se. Fourth, the studies used in this analysis often tailored the types 

of counseling and behavioral therapies to the needs of specific populations 

being studied, thereby affecting the generalizability of the study results. 

Fifth, there was considerable heterogeneity within each type of counseling 

and behavioral therapy. 

Tables 6.19 and 6.20 outline elements of practical counseling (problemsolving/skills training) and intratreatment social support, respectively. These 

tables are designed to help clinicians using these counseling and behavioral 

therapies. It must be noted, however, that these treatment labels are nonspecific and include heterogeneous treatment elements. The effectiveness 

of encouragement and support as part of treatment is consistent with the 

literature regarding the importance of providing a caring, empathic, and 

understanding context in making other health behavior changes.278-280

Table 6.19. Common elements of practical counseling (problemsolving/skills 

training)

Practical counseling (problemsolving/

skills training) treatment component Examples

Recognize danger situations – Identify 

events, internal states, or activities that 

increase the risk of smoking or relapse.

• Negative affect and stress

• Being around other tobacco users

• Drinking alcohol

• Experiencing urges

• Smoking cues and availability of cigarettes

Develop coping skills – Identify and 

practice coping or problemsolving 

skills. Typically, these skills are intended 

to cope with danger situations.

• Learning to anticipate and avoid temptation and trigger situations

• Learning cognitive strategies that will 

reduce negative moods

• Accomplishing lifestyle changes that 

reduce stress, improve quality of life, and 

reduce exposure to smoking cues

• Learning cognitive and behavioral activities to cope with smoking urges (e.g., 

distracting attention; changing routines)
Evidence and Recommendations

99

Practical counseling (problemsolving/

skills training) treatment component Examples

Provide basic information – Provide 

basic information about smoking and 

successful quitting.

• The fact that any smoking (even a single 

puff) increases the likelihood of a full 

relapse

• Withdrawal symptoms typically peak 

within 1–2 weeks after quitting but may 

persist for months. These symptoms include negative mood, urges to smoke, and 

difficulty concentrating.

• The addictive nature of smoking

Table 6.20. Common elements of intratreatment supportive interventions

Supportive treatment component Examples

Encourage the patient in the quit 

attempt.

• Note that effective tobacco dependence 

treatments are now available.

• Note that one-half of all people who have 

ever smoked have now quit.

• Communicate belief in patient’s ability to 

quit.

Communicate caring and concern. • Ask how patient feels about quitting. 

• Directly express concern and willingness 

to help as often as needed.

• Ask about the patient’s fears and ambivalence regarding quitting.

Encourage the patient to talk about the 

quitting process.

Ask about:

• Reasons the patient wants to quit.

• Concerns or worries about quitting.

• Success the patient has achieved.

• Difficulties encountered while quitting.

Acupuncture. A separate meta-analysis was conducted in 2000 to evaluate 

the effectiveness of acupuncture. Evidence, as shown in Table 6.21, did not 

support the effectiveness of acupuncture as a tobacco use treatment. The 

acupuncture meta-analysis comparing “active” acupuncture with “control” 

acupuncture (see Glossary) revealed no difference in effectiveness between 

the two types of procedures. These results suggest that any effect of acupuncture might be produced by other factors such as positive expectations 

about the procedure. These results are consistent with the more recent Cochrane analysis.281 Moreover, the Guideline Panel did not identify scientific 

literature to support the effectiveness of the more recent electrostimulation 

or laser acupuncture treatments for tobacco use.

Table 6.19. Common elements of practical counseling (problemsolving/skills 

training) (continued)
Treating Tobacco Use and Dependence: 2008 Update

100

Hypnosis. The 1996 Guideline did not conduct a separate meta-analysis 

on hypnosis because few studies met inclusion criteria, and those that did 

used very heterogeneous hypnotic procedures. There was no common or 

standard intervention technique to analyze. Literature screening for the 

2000 Guideline revealed no new published studies on the treatment of 

tobacco dependence by hypnosis that met the inclusion criteria; therefore, 

this topic was not reexamined. Moreover, an independent review of nine 

hypnotherapy trials by the Cochrane Group found insufficient evidence to 

support hypnosis as a treatment for smoking cessation.282 In contrast to the 

Cochrane Review and other reviews, a small recent study reported preliminary positive results with hypnotherapy.283

Other Interventions. The number of studies was insufficient to accurately 

appraise the effectiveness of other types of counseling and behavioral 

therapies, such as physiological feedback, restricted environmental stimulation therapy,284 and the use of incentives.285

Table 6.21. Meta-analysis (2000): Effectiveness of and estimated abstinence rates 

for acupuncture (n = 5 studies)a

Treatment Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

Placebo 7 1.0 8.3

Acupuncture 8 1.1 (0.7–1.6) 8.9 (5.5–12.3)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Future Research

The following topics regarding types of counseling and behavioral therapies require additional research:

•	 Effectiveness of motivational interventions, cigarette fading, and physiological feedback of smoking effects 

•	Mechanisms through which counseling interventions exert their effects

•	 Effectiveness of specific counseling interventions among various patient populations (e.g., those with cancers; chronic obstructive pulmonary disease [COPD]; psychiatric disorders, including substance use 

disorders; and atherosclerosis)
Evidence and Recommendations

101

•	 Effectiveness of smokefree policies, particularly smokefree homes and

worksites, on increasing interest in, and the effectiveness of, tobacco 

dependence treatment286

•	 Effectiveness of family systems interventions as a means to increase

support

 Combining Counseling and Medication

Recommendation: The combination of counseling and medication 

is more effective for smoking cessation than either medication or 

counseling alone. Therefore, whenever feasible and appropriate, both 

counseling and medication should be provided to patients trying to quit 

smoking. (Strength of Evidence = A)

Recommendation: There is a strong relation between the number of 

sessions of counseling, when it is combined with medication, and the 

likelihood of successful smoking cessation. Therefore, to the extent 

possible, clinicians should provide multiple counseling sessions, 

in addition to medication, to their patients who are trying to quit 

smoking. (Strength of Evidence = A)

Evidence in this Guideline update supports the independent effectiveness 

of both counseling interventions and medication interventions. In the 2008 

Guideline update, the Panel evaluated whether combining counseling and 

medication improved cessation rates relative to using either of these treatments alone. 

Providing Counseling in Addition to Medication. Eighteen studies met 

selection criteria to evaluate the effectiveness of providing counseling in 

addition to medication versus medication alone. The results of this 2008 

meta-analysis indicate that providing counseling in addition to medication 

significantly enhances treatment outcomes (see Table 6.22). These same 18 

studies also were analyzed to examine the relation of counseling intensity 

when it was used in combination with a medication. Results revealed that 

two or more sessions significantly enhance treatment outcomes, and more 

than eight sessions produced the highest abstinence rates (see Table 6.23). 

The counseling provided in these studies was delivered either in person or 

via telephone.
Treating Tobacco Use and Dependence: 2008 Update

102

Table 6.22. Meta-analysis (2008): Effectiveness of and estimated abstinence 

rates for the combination of counseling and medication vs. medication alone 

(n = 18 studies)a

Treatment Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

Medication alone 8 1.0 21.7

Medication and 

counseling 39 1.4 (1.2–1.6) 27.6 (25.0–30.3)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Table 6.23. Meta-analysis (2008): Effectiveness of and estimated abstinence rates 

for the number of sessions of counseling in combination with medication vs. medication alone (n = 18 studies)a

Treatment Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

0–1 session plus 

medication 13 1.0 21.8

2–3 sessions plus 

medication 6 1.4 (1.1–1.8) 28.0 (23.0–33.6)

4–8 sessions plus 

medication 19 1.3 (1.1–1.5) 26.9 (24.3–29.7)

More than 8 sessions plus medication

9 1.7 (1.3–2.2) 32.5 (27.3–38.3)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Providing Medication in Addition to Counseling. The effect of adding medication to counseling also was examined. Nine studies met inclusion criteria 

and provided 24 arms to compare medication and counseling with counseling alone. The results of this 2008 meta-analysis indicate that providing 

medication in addition to counseling significantly enhances treatment 

outcomes (see Table 6.24). 
Evidence and Recommendations

103

Table 6.24. Meta-analysis (2008): Effectiveness of and estimated abstinence 

rates for the combination of counseling and medication vs. counseling alone 

(n = 9 studies)a

Treatment Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

Counseling alone 11 1.0 14.6

Medication and 

counseling 13 1.7 (1.3–2.1) 22.1 (18.1–26.8)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Medication and/or counseling are effective and should be provided as 

stand-alone interventions when it is not feasible to do both or the patient 

is not interested in both. By combining medication and counseling, however, the clinician can significantly improve abstinence rates. The clinician 

providing the medication does not need to be the clinician providing the 

counseling. It may be that a physician, dentist, physician assistant, or nurse 

practitioner could prescribe medicine, and counseling could be provided 

by a health educator, dental hygienist, tobacco treatment specialist, pharmacist, or quitline. Adherence to treatment, both medication and counseling, is important for optimal outcomes. Even though there is compelling 

evidence that both counseling and medications increase smoking cessation 

success, the clinician should encourage the patient to make a quit attempt 

even if she or he declines such treatment.

 Future Research

The following topics regarding the combination of counseling and medication require additional research:

•	 Optimal timing and length of counseling and medication interventions

(e.g., timing and spacing of postquit counseling sessions)

•	 Effectiveness and acceptability/appeal of different counseling formats

and techniques (e.g., computer-based counseling, quitline counseling, 

motivational interviewing)

•	 Strategies to address misconceptions about effective counseling and

medication treatments

•	 Relative cost-effectiveness of various treatment combinations
Treating Tobacco Use and Dependence: 2008 Update

104

 For Smokers Not Willing To Make a Quit Attempt 

 At This Time

Recommendation: Motivational intervention techniques appear to be 

effective in increasing a patient’s likelihood of making a future quit 

attempt. Therefore, clinicians should use motivational techniques to 

encourage smokers who are not currently willing to quit to consider 

making a quit attempt in the future. (Strength of Evidence = B)

Evidence suggests that a variety of motivational interventions can increase the motivation for behavior change. These interventions have varied 

contents and labels (e.g., individualized motivational intervention, motivational consulting, and motivational interviewing; see e.g., Chan et al.,170

Butler et al.,171 and Brown et al.173). The motivational intervention that has 

perhaps the greatest level of support and content specificity is motivational 

interviewing. 

Motivational interviewing (MI) is a specific counseling strategy that is 

intended to increase a person’s motivation for behavior change.168 MI comprises a variety of strategies that are designed to help individuals resolve 

ambivalence about such change.175 The technique has been used successfully to help individuals attempt and achieve many types of behavior change, 

including reduced drinking and illicit drug use, and reduction of HIV risk 

behaviors.175,287,288

Several studies have shown that MI techniques appear to be effective in 

motivating smokers to make quit attempts. A randomized controlled trial 

of an MI-based intervention among 137 smokers with cancer found that 

MI significantly increased quit attempts compared to an advice condition.289 Another study found that a single session of MI, versus either brief 

psychoeducational counseling or advice, significantly increased the proportion of patients with schizophrenia who contacted a tobacco dependence 

treatment provider and attended an initial treatment session.174 A third 

study showed that two 45-minute individual counseling sessions based on 

MI principles yielded higher levels of intention to quit smoking among 

adolescents than did a brief advice condition.173 No differences in quitting 

attempts or quitting success were seen in that study, however. Studies that 

used motivational approaches that shared features of MI (but that were not 
Evidence and Recommendations

105

MI) yielded a mixed pattern of results, with some studies showing significant increases in quit attempts (see, e.g., Butler et al.171); others showed 

only trends in that direction.170 Finally, one study that targeted unmotivated smokers showed that counseling based on the “5 R’s” (see Chapter 3, 

Strategy B2) significantly increased the odds of making a quit attempt that 

lasted at least 24 hours.169

The available evidence shows that the reviewed motivational interventions 

such as MI increase quit attempts when used with individuals not already 

interested in quitting. The evidence does not show that such interventions 

are reliably effective as cessation treatments,173,175,290 nor is there consistent 

evidence that MI-induced quit attempts translate into higher long-term 

abstinence rates. Evidence also shows that such interventions are more 

effective in smokers with little pre-existing motivation to quit.171,173 Finally, 

some evidence suggests that extensive training is needed before competence is achieved in the MI technique.175,291

Physiological Monitoring/Biological Marker Feedback To 

Motivate Smokers To Quit

Investigators have sought to determine whether feedback regarding either 

smoking effects or disease risk motivates quit attempts. Modest evidence 

indicates that such feedback motivates quit attempts.292 One small study 

found that multifaceted feedback involving CO level, vital capacity 

measurement, and discussion of pulmonary symptoms led to more quit 

attempts among smokers identified during routine medical screening.293 In 

a second study, feedback regarding CO level and genetic susceptibility to 

cancer was associated with a greater likelihood of quit attempts 1 year later.294

Although these results are encouraging, there is too little information to 

evaluate definitively the effects of physiological feedback.284 In addition, 

there is insufficient information as to how this feedback affects those at 

different levels of readiness to quit. It also is unclear whether feedback that 

a person is not at high risk would encourage continued smoking. Finally, 

data are mixed regarding the effectiveness of feedback as a cessation versus 

motivational intervention. That is, data are mixed as to whether or not 

feedback increases abstinence rates.284,295,296
Treating Tobacco Use and Dependence: 2008 Update

106

Future Research

The following topics require additional research:

• Effectiveness of motivational interviewing and related techniques, 

including the impact of brief motivational interviewing strategies 

delivered in primary care settings

• Effectiveness of physiological monitoring and biological marker feedback to motivate smokers to quit and increase abstinence rates

B. Medication Evidence

Recommendation: Clinicians should encourage all patients attempting 

to quit to use effective medications for tobacco dependence treatment, 

except where contraindicated or for specific populations for which there 

is insufficient evidence of effectiveness (i.e., pregnant women, smokeless 

tobacco users, light smokers, and adolescents). (Strength of Evidence = A)

As with other chronic diseases, the most effective treatment of tobacco 

dependence requires the use of multiple clinical modalities. Medications 

are a vital element of a multicomponent approach. The clinician should 

encourage all patients initiating a quit attempt to use one or a combination 

of effective medications, although medication use may not be appropriate with some patient groups (e.g., those with medical contraindications, 

those smoking fewer than 10 cigarettes a day, pregnant/breastfeeding 

women, smokeless tobacco users, and adolescent smokers). The Guideline 

Panel identified seven first-line (FDA-approved) medications (bupropion 

SR, nicotine gum, nicotine inhaler, nicotine lozenge, nicotine nasal spray, 

nicotine patch, and varenicline) and two second-line (non-FDA-approved 

for tobacco use treatment) medications (clonidine and nortriptyline) as 

being effective for treating smokers. Each has been documented to increase 

significantly rates of long-term smoking abstinence. These results are consistent with other independent reviews.158,297-300 No other medication treatments were consistently supported by the available scientific evidence.

In this update, the Panel conducted an inclusive meta-analysis of medications that complements the inclusive meta-analysis of psychosocial interventions that was conducted for the 2000 Guideline. For this meta-analysis, 

all medication trials with at least two studies of a particular medication, 
Evidence and Recommendations

107

at an appropriate dose and duration, were entered into one analysis. This 

inclusive medication meta-analysis allows for the comparison of particular 

medications to both placebo controls and other active medications (Table 

6.26), and makes greater use of all information in the available studies. 

Note also that, although all of these studies were published in peer-reviewed journals, a number of the studies were supported by the pharmaceutical industry.

The medication meta-analysis included predominantly studies with “selfselected” populations (see Chapter 1, Overview and Methods). In addition, 

in medication studies both experimental and control subjects in the studies 

typically received substantial counseling. Both of these factors tend to 

produce higher abstinence rates than typically are observed among selfquitters.

The studies submitted to the inclusive medications meta-analysis were 

screened and categorized prior to analysis. Screening removed medications 

for which there were too few acceptable studies to submit to meta-analysis 

(e.g., the nicotine lozenge, selegeline), and removed study arms that were 

confounded (e.g., two different medication conditions had counseling 

adjuvants of different intensities). Decisions about cutscores for treatment 

duration and dose categories were designed to be consistent with package insert information and data on effectiveness (i.e., prior data indicated 

rough clinical equivalence of certain dosages). Therefore, although there 

was an attempt to achieve some uniformity across the medications, decisions about dose and duration categories necessarily were made on a 

medication-by-medication basis. It is important to note that some medication categories, and some medication recommendations, do not conform 

with manufacturers’ recommendations (e.g., the use of a nicotine patch 

dose > 25 mg per day). Table 6.25 shows the dosage and duration inclusion 

criteria for normal course, long-term, and high-dose medication classifications. In the case of medication combinations, the combinations typically 

comprised two standard-length medication regimens. In one combination, 

however, ad libitum NRT (gum or spray) was paired with long-term nicotine patch use (“patch [long-term] + Ad Lib NRT”). Different medications 

were grouped together into a single use category (e.g., grouping nicotine 

gum and spray together into the “Long-term Ad Lib NRT” condition) 

when the grouping was clinically and conceptually meaningful and when 

it permitted greater use of the available research evidence. Analyses were 

conducted for both 6- and 12-month outcomes, and the results of the 
Treating Tobacco Use and Dependence: 2008 Update

108

12-month analyses were very similar to the 6-month results shown in Table 

6.26.

Table 6.25. Coding rules for medication duration and dose

Medication Coding Meaning

Nicotine Patch Usual duration 6–14 weeks

Long duration > 14 weeks

Usual dose/day 15 mg/16 hours/day

21 mg/24 hours/day

High dose > 25 mg/day

Nicotine Gum Usual duration 6–14 weeks

Long duration > 14 weeks

Nicotine Inhaler and Nasal 

Spray 

Usual duration Up to 6 months

Long duration > 6 months

Bupropion SR Usual duration Up to 14 weeks

Usual dose/day 150 mg once daily or 

twice daily

Varenicline Usual duration Up to 14 weeks

Usual dose/day 1 mg daily or 1 mg twice daily 

(analyzed separately)

Recommendations Regarding Individual 

Medications: First-Line Medications

First-line medications are those that have been found to be safe and effective for tobacco dependence treatment and that have been approved by 

the FDA for this use, except in the presence of contraindications or with 

specific populations for which there is insufficient evidence of effectiveness 

(i.e., pregnant women, smokeless tobacco users, light smokers, and adolescents). These first-line medications have an established empirical record of 

effectiveness, and clinicians should consider these agents first in choosing 

a medication. For the 2008 update, the first-line medications are listed in 

Table 6.26 by size of the odds ratio and in the text alphabetically by generic 

name. 
Evidence and Recommendations

109

Table 6.26. Meta-analysis (2008): Effectiveness and abstinence rates for various 

medications and medication combinations compared to placebo at 6-months 

postquit (n = 83 studies)a

Medication Number 

of arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence 

rate (95% C.I.)

Placebo 80 1.0 13.8

Monotherapies

Varenicline (2 mg/day) 5 3.1 (2.5–3.8) 33.2 (28.9–37.8)

Nicotine Nasal Spray 4 2.3 (1.7–3.0) 26.7 (21.5–32.7)

High-Dose Nicotine Patch ( > 25 

mg) (These included both standard or long-term duration)4 2.3 (1.7–3.0) 26.5 (21.3–32.5)

Long-Term Nicotine Gum (> 14 

weeks) 6 2.2 (1.5–3.2) 26.1 (19.7–33.6)

Varenicline (1 mg/day) 3 2.1 (1.5–3.0) 25.4 (19.6–32.2)

Nicotine Inhaler 6 2.1 (1.5–2.9) 24.8 (19.1–31.6)

Clonidine 3 2.1 (1.2–3.7) 25.0 (15.7–37.3) 

Bupropion SR 26 2.0 (1.8–2.2) 24.2 (22.2–26.4)

Nicotine Patch (6–14 weeks) 32 1.9 (1.7–2.2) 23.4 (21.3–25.8)

Long-Term Nicotine Patch (> 14 

weeks) 10 1.9 (1.7–2.3) 23.7 (21.0–26.6)

Nortriptyline 5 1.8 (1.3–2.6) 22.5 (16.8–29.4)

Nicotine Gum (6–14 weeks) 15 1.5 (1.2–1.7) 19.0 (16.5–21.9)

Combination therapies

Patch (long-term; > 14 weeks) + 

ad lib NRT (gum or spray) 3 3.6 (2.5–5.2) 36.5 (28.6–45.3)

Patch + Bupropion SR 3 2.5 (1.9–3.4) 28.9 (23.5–35.1)

Patch + Nortriptyline 2 2.3 (1.3–4.2) 27.3 (17.2–40.4)

Patch + Inhaler 2 2.2 (1.3– 3.6) 25.8 (17.4–36.5)

Patch + Second generation 

antidepressants (paroxetine, 

venlafaxine) 

3 2.0 (1.2–3.4) 24.3 (16.1–35.0)

Medications not shown to be 

effective

Selective Serotonin Re-uptake 

Inhibitors (SSRIs) 3 1.0 (0.7–1.4) 13.7 (10.2–18.0)

Naltrexone 2 0.5 (0.2–1.2) 7.3 (3.1–16.2)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.
Treating Tobacco Use and Dependence: 2008 Update

110

 Bupropion SR (Sustained Release)

Recommendation: Bupropion SR is an effective smoking cessation treatment that patients should be encouraged to use. (Strength of Evidence = A)

Bupropion SR was the first non-nicotine medication shown to be effective 

for smoking cessation and was approved by the FDA for that use in 1997. 

Its possible mechanisms of action include blockade of neuronal re-uptake 

of dopamine and norepinephrine and blockade of nicotinic acetylcholinergic receptors. It is contraindicated in patients with a seizure disorder, a 

current or prior diagnosis of bulimia or anorexia nervosa, use of a monoamine oxidase (MAO) inhibitor within the previous 14 days, or in patients 

taking another medication that contains bupropion. Bupropion SR is available exclusively as a prescription medication and can be used in combination with nicotine replacement therapies. Suggestions regarding the clinical 

use of bupropion SR are provided in Table 3.3.

Twenty-four studies generated the 26 arms that served as the basis for 

estimating the bupropion SR effect. The bupropion SR dose was 150 mg for 

3 of these study arms, and 300 mg for the other 22 of these arms (one study 

did not report dose). As Table 6.26 reveals, bupropion SR approximately 

doubles the likelihood of long-term (> 5 month) abstinence from tobacco 

use as compared to placebo treatment. These results are consistent with 

other independent reviews.299

 Nicotine Replacement Therapies (NRTs)

Nicotine replacement therapy (NRT) medications deliver nicotine with the 

intent to replace, at least partially, the nicotine obtained from cigarettes 

and to reduce the severity of nicotine withdrawal symptoms.

Nicotine Gum

Recommendation: Nicotine gum is an effective smoking cessation treatment that patients should be encouraged to use. (Strength of Evidence = A)

Recommendation: Clinicians should offer 4 mg rather than 2 mg nicotine gum to highly dependent smokers. (Strength of Evidence = B)
Evidence and Recommendations

111

Nicotine gum currently is available exclusively as an OTC medication 

and is packaged with important instructions on correct usage, including chewing (see Table 3.4 for information on the clinical use of nicotine 

gum). Nine studies generated the 15 study arms that served as the basis 

for estimating the effect of nicotine gum. In addition, another four studies 

generated the six arms that served as the basis for the estimation of effects 

of long-term gum use (directed use beyond 14 weeks). Two arms used gum 

for 52 weeks, and the other four arms used gum for 24–26 weeks. Table 

6.26 reveals that regular course and long-term nicotine gum use increased 

the likelihood of long-term abstinence by about 50 percent compared to 

placebo treatment. These results are consistent with other independent 

reviews.300

Nicotine Inhaler

Recommendation: The nicotine inhaler is an effective smoking cessation treatment that patients should be encouraged to use. (Strength of 

Evidence = A)

The nicotine inhaler currently is available exclusively as a prescription 

medication. The nicotine inhaler is not a true pulmonary inhaler, but rather deposits nicotine in the oropharynx, from which it is absorbed across 

the mucosa. See Table 3.5 for suggestions regarding the clinical use of the 

nicotine inhaler. Six studies generated the six arms that served as the basis 

for estimating the nicotine inhaler effect. As Table 6.26 shows, the inhaler 

approximately doubled smokers’ likelihood of long-term abstinence from 

tobacco as compared to placebo treatment. These results are consistent 

with other independent reviews.300

Nicotine Lozenge

Recommendation: The nicotine lozenge is an effective smoking cessation treatment that patients should be encouraged to use. (Strength of 

Evidence = B)

Nicotine lozenge is available exclusively as an OTC medication and is packaged with important instructions for correct usage (see Table 3.6). Only 

one randomized controlled trial of the nicotine lozenge was available for 

review.301 Therefore, the nicotine lozenge was not included in the inclusive 

meta-analysis (Table 6.26). The data from this study of more than 1,800 

smokers found that the 2-mg lozenge for low-dependent smokers (smoke 
Treating Tobacco Use and Dependence: 2008 Update

112

a first cigarette 30 minutes or more after waking) approximately doubled 

and the 4-mg lozenge for highly dependent smokers (smoke a first cigarette 

within 30 minutes of waking) approximately tripled the odds of abstinence 

at 6 months postquit as compared to placebo treatment. See Table 6.27 

for the study results. These results are consistent with other independent 

reviews.300

Table 6.27. Effectiveness of the nicotine lozenge: Results from the single randomized controlled trial

Lozenge dose N for active/N for 

placebo

Odds Ratio 

(95% C.I.)

Continuous abstinence rates at 

6 months (Active/Placebo)

2 mg 459/458 2.0 (1.4–2. 8) 24.2/14.4

4 mg 450/451 2.8 (1.9–4.0) 23.6/10.2

Nicotine Nasal Spray

Recommendation: Nicotine nasal spray is an effective smoking cessation treatment that patients should be encouraged to use. (Strength of 

Evidence = A)

The nicotine nasal spray currently is available exclusively as a prescription 

medication. See Table 3.7 for suggestions regarding the clinical use of the 

nicotine nasal spray. Four studies generated the four study arms that served 

as the basis for estimating the nasal spray effect. As Table 6.26 reveals, the 

nasal spray more than doubles the likelihood of long-term abstinence from 

tobacco as compared to placebo treatment. 

Nicotine Patch

Recommendation: The nicotine patch is an effective smoking cessation treatment that patients should be encouraged to use. (Strength of 

Evidence = A)

Nicotine patches currently are available both as an OTC medication and as 

a prescription medication. Awareness of this prescription option is important for insurance plans that include coverage only for prescription medications. Suggestions for the clinical use of the nicotine patch are provided 

in Table 3.8.
Evidence and Recommendations

113

Twenty-five studies generated the 32 study arms that served as the basis for 

estimating the nicotine patch effect. Of these 32 arms, the peak dose used 

was 14 or 15 mg in 6 study arms and 21–25 mg in 25 arms (one study did 

not report dose). As Table 6.26 shows, the nicotine patch almost doubled 

the likelihood of long-term abstinence compared to placebo treatment. 

These results are consistent with other independent reviews.300

The meta-analysis also addressed the effectiveness of long-term and highdose nicotine patch therapy. As noted in Table 6.25, high-dose therapy 

was coded when the highest dose used exceeded 25 mg. This often was 

achieved by using two patches per day as a dosing regimen. Four studies 

generated four analyzable study arms with peak patch dosages of 30 mg 

(2 arms), 35 mg (1 arm), and 42 mg (1 arm). In some of these high-dose 

arms, patch use was of regular duration (14 weeks or less), although in 

other arms the duration of directed patch use exceeded 14 weeks. 

Table 6.25 shows that long-term patch therapy was coded when the duration of directed patch use exceeded 14 weeks. All of the long-term patch 

studies used regular-dose patch regimens (15–25 mg). Eight studies generated 10 study arms that served as the basis for estimating the effect of 

long-term patch therapy. Table 6.26 shows that both long-term therapy 

and high-dose patch therapy approximately doubled the likelihood that a 

smoker would achieve long-term abstinence relative to placebo treatment. 

Thus, neither high-dose nor long-term patch therapy appeared to produce 

benefit above and beyond that of nicotine patch therapy at the regular duration (6–14 weeks) and dose (14–25 mg). 

A time trend analysis of the nicotine patch studies based on data from the 

current meta-analysis revealed no significant change in the effectiveness of 

the nicotine patch during the approximately 15 years it has been available.

 Varenicline

Recommendation: Varenicline is an effective smoking cessation treatment 

that patients should be encouraged to use. (Strength of Evidence = A)

Varenicline is a non-nicotine medication that was approved by the FDA for 

the treatment of tobacco dependence in 2006. Its mechanism of action is 

presumed to be due to its partial nicotine receptor agonist and antagonist 

effects. It is well tolerated in most patients. However, a recent publication 
Treating Tobacco Use and Dependence: 2008 Update

114

reported two case reports of exacerbations of existing psychiatric illness, 

schizophrenia and bipolar illness, in patients who took varenicline.302,303 In 

contrast, one recent smoking cessation study using varenicline included 

smokers with mental illness (depression, bipolar disorder, and/or psychosis) and reported no evidence that varenicline worsened the patients’ 

mental illness.304 Importantly, the FDA noted that patients with psychiatric 

illness were not included in the studies conducted for the approval of this 

medication.

In February 2008, the FDA added a warning regarding the use of varenicline. Specifically, it noted that depressed mood, agitation, changes in 

behavior, suicidal ideation, and suicide have been reported in patients 

attempting to quit smoking while using varenicline. The FDA recommends (1) that patients tell their health care provider about any history of 

psychiatric illness prior to starting this medication; and (2) that clinicians 

monitor patients for changes in mood and behavior when prescribing this 

medication. In light of these FDA recommendations, clinicians should 

consider eliciting information on their patients’ psychiatric history.

Because varenicline is eliminated almost entirely unchanged in the urine, 

it should be used with caution in patients with severe renal dysfunction 

(creatinine clearance < 30 ml per min). Varenicline is available exclusively 

as a prescription medication and is not recommended for use in combination with NRT because of its nicotine antagonist properties. One recent 

review297 found that varenicline increased odds of quitting over that of 

bupropion SR with a minimal to moderate side effect profile. Suggestions 

regarding the clinical use of varenicline are presented in Table 3.9.

The FDA dosing recommendation for varenicline is a total of 2 mg per day 

(1 mg twice daily). However, there is evidence that a dose of 1 mg per day 

also is effective.305 Therefore, the effectiveness of both doses was addressed 

in the inclusive meta-analysis. Four studies generated five study arms that 

served as the basis for estimating the effect of 2 mg varenicline. Two studies 

generated the three study arms that served as the basis for estimating the 

effect of 1 mg varenicline. As Table 6.26 shows, the 1 mg total daily dose of 

varenicline approximately doubles, and the 2 mg total daily dose of varenicline approximately triples, a smoker’s likelihood of long-term abstinence 

from tobacco as compared to placebo treatment. This suggests that the 1 

mg per day dose is a viable alternative to the 2 mg per day dose, should the 

patient experience dose-related side effects. 
Evidence and Recommendations

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Evidence indicates that varenicline is well-tolerated for periods up to 1 

year306 and that extended treatment may prove useful in reducing the likelihood of relapse.307 More research is needed, however, to evaluate varenicline as a relapse prevention medication, to assess its long-term effects, and 

to evaluate its effectiveness in specific populations.

 Interactions of First-Line Tobacco Use Medications

 With Other Drugs

The goal of treating tobacco use and dependence is abstinence from tobacco products. In achieving this goal, the metabolic effects of tobacco abstinence must be understood with respect to potential changes in homeostasis that occur in response to quitting and, eventually, the elimination of 

nicotine from the body. This is particularly important for smokers who are 

on other medications for chronic disease state management because they 

essentially are in a homeostatic metabolic condition and the titration of 

their chronic disease medications may have been influenced by their smoking status. 

The polycyclic aromatic hydrocarbons in tobacco smoke are metabolic 

inducers of some isoforms of the hepatic cytochrome P450.308 Thus, when 

smokers quit and the P450 system returns to its basal level of functioning, 

the concentration of drugs metabolized by these particular CYP isoforms 

may increase. As a result, smokers who quit can experience side effects 

from supratherapeutic drug levels of caffeine, theophylline, fluvoxamine, 

olanzapine, and clozapine. This can have serious consequences for selective 

drugs such as clozapine, with its associated agranulocytosis.309

Although nicotine is metabolized by CYP2A6, it does not appear to induce, in a clinically significant way, CYP enzymes. Thus, when a smoker 

is switched from cigarettes to a nicotine replacement product, changes in 

drug metabolism are similar to those seen when quitting without NRT.

Nicotine produces sympathetic activation that may reduce the sedative 

effects of benzodiazepines, and the vasoconstrictive effects of nicotine may 

decrease subcutaneous absorption of insulin. Nicotine also may attenuate 

the ability of beta-blockers to lower blood pressure and heart rate and may 

lessen opioid analgesia. When nicotine replacement products are withdrawn, adjustments in these types of medications may be necessary.
Treating Tobacco Use and Dependence: 2008 Update

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The metabolism of bupropion is mediated primarily by CYP2B6. Three categories of drugs could have clinically significant interactions with bupropion: drugs affecting CYP2B6, drugs metabolized by CYP2D6, and general 

enzyme inducers/inhibitors.310 Drugs that affect CYP2B6 metabolism, such 

as cyclophosphamide and orphenadrine, potentially could alter bupropion metabolism. Bupropion and its metabolites inhibit CYP2D6311,312 and 

could affect the impact of agents metabolized by this enzyme (e.g., tricyclic 

antidepressants, antipsychotics, type 1C anitarrhythmics, or certain betablockers). Due to the extensive metabolism of bupropion, enzyme inducers (e.g., carbamazepine, phenobarbital, phenytoin) and inhibitors (e.g., 

valproate, cimetidine) may alter its plasma concentration. Bupropion can 

lower seizure threshold. It should be used with caution with medications 

that can also lower seizure threshold.310,313 Specifically, use of bupropion 

within 14 days of discontinuation of therapy with any MAO inhibitor is 

contraindicated.

Varenicline is eliminated unchanged by kidney excretion and thus is 

believed to pose no metabolic effects. Cimetidine inhibits the renal secretion of varenicline, although the magnitude of the interaction is small. No 

significant drug-drug interactions are known.314

Recommendations Regarding Second-Line 

Medications

Second-line medications are medications for which there is evidence of 

effectiveness for treating tobacco dependence, but they have a more limited role than first-line medications because: (1) the FDA has not approved 

them for a tobacco dependence treatment indication; and (2) there are 

more concerns about potential side effects than exist with first-line medications. Second-line medications should be considered for use on a caseby-case basis after first-line medications (either alone or in combination) 

have been used without success or are contraindicated. The listing of the 

second-line medications is alphabetical by generic name.

 Clonidine

Recommendation: Clonidine is an effective smoking cessation treatment. It may be used under a physician’s supervision as a second-line 

agent to treat tobacco dependence. (Strength of Evidence = A)
Evidence and Recommendations

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Three studies generated three analyzable study arms that served as the basis 

for estimating clonidine’s effects on long-term abstinence. These studies all 

were conducted prior to 1997. Table 6.26 reveals that the use of clonidine 

approximately doubles abstinence rates when compared to a placebo. These 

studies varied the clonidine dose from 0.1 to 0.75 mg per day. The drug 

was delivered either transdermally or orally. It should be noted that abrupt 

discontinuation of clonidine can result in symptoms such as nervousness, 

agitation, headache, and tremor, accompanied or followed by a rapid rise in 

blood pressure and elevated catecholamine levels.

Clonidine is used primarily as an antihypertensive medication and has not 

been approved by the FDA as a medication for treating tobacco use and 

dependence. Therefore, clinicians need to be aware of the specific warnings 

regarding this medication as well as its side-effect profile. Additionally, a 

specific dosing regimen for the use of clonidine in smoking cessation has 

not been established. The Guideline Panel chose to recommend clonidine 

as a second-line as opposed to first-line agent because of the warnings associated with clonidine discontinuation, variability in dosages used to test 

this medication, and lack of FDA approval. As such, clonidine should be 

considered for treating tobacco use under a physician’s monitoring with 

patients unable to use first-line medications because of contraindications 

or with patients who were unable to quit when using first-line medications. 

An independent review298 indicated that clonidine is effective in promoting 

smoking abstinence, but prominent side effects limit its usefulness. Suggestions regarding clinical use of clonidine are provided in Table 3.10.

 Nortriptyline

Recommendation: Nortriptyline is an effective smoking cessation treatment. It may be used under a physician’s supervision as a second-line 

agent to treat tobacco dependence. (Strength of Evidence = A)

Four studies generated the five analyzable study arms that served as the 

basis for estimating the effect of nortriptyline on long-term abstinence. 

Nortriptyline dosages were 75 mg per day (3 arms) and 100 mg per day 

(2 arms), with treatment lasting from 6 to 13 weeks across the five arms. 

As Table 6.26 shows, nortriptyline almost doubles a smoker’s likelihood 

of achieving long-term abstinence from tobacco as compared to placebo 

treatment. A recent independent review158 also indicated that nortriptyline 

is effective in treating tobacco dependence. Suggestions regarding the 
Treating Tobacco Use and Dependence: 2008 Update

118

clinical use of nortriptyline are provided in Table 3.11. Nortriptyline 

is used primarily as an antidepressant and has not been evaluated or 

approved by the FDA as a medication for treating tobacco use and 

dependence. Clinicians need to be aware of the specific warnings regarding 

this medication as well as its side-effect profile. Because of the side-effect 

profile and the lack of FDA approval for tobacco dependence treatment, 

nortriptyline is recommended as a second-line rather than a first-line 

agent. As such, nortriptyline should be considered for treating tobacco 

use under a physician’s direction with patients unable to use first-line 

medications because of contraindications or with patients who were unable 

to quit using first-line medications. 

Combination Medications

Recommendation: Certain combinations of first-line medications have 

been shown to be effective smoking cessation treatments. Therefore, 

clinicians should consider using these combinations of medications 

with their patients who are willing to quit. Effective combination medications are:

•	Long-term ( > 14 weeks) nicotine patch + other NRT (gum and 

spray)

•	The nicotine patch + the nicotine inhaler

•	The nicotine patch + bupropion SR (Strength of Evidence = A)

The number and variety of analyzable articles was sufficient to assess the 

effectiveness of five combinations of medications relative to placebo. Only 

the patch + bupropion combination has been approved by the FDA for 

smoking cessation. 

 Nicotine Patch + Bupropion SR

Three studies yielded three analyzable study arms that served as the basis 

for estimating the effect of the nicotine patch + bupropion SR on long-term 

abstinence. Both the patch and bupropion SR were used at standard durations and doses (see Table 6.25).
Evidence and Recommendations

119

 Nicotine Patch + Nicotine Inhaler

Two studies generated two arms that served as the basis for estimating the 

effect of the nicotine patch + the nicotine inhaler. The 15-mg patch was 

used in both studies at a regular treatment duration. The directed duration 

of use of the inhaler was 12 weeks in one arm and 26 weeks in the other 

arm.

 Long-Term Nicotine Patch Use + Ad Libitum NRT

Three studies yielded three analyzable study arms that served as the basis 

for estimating the effect of long-term nicotine patch use + ad libitum NRT 

use. All arms involved nicotine patch therapy that exceeded 14 weeks, with 

durations that ranged from 18 to 24 weeks. The ad libitum NRT condition 

involved nicotine gum in two arms and the nicotine nasal spray in one 

arm. The two gum arms both used 2-mg gum, with directed use lasting 26 

weeks in one arm and 52 weeks in another arm. The third arm involved 

nicotine nasal spray, with directed use lasting 52 weeks.

 Nicotine Patch + Nortriptyline

Two studies generated three analyzable arms that served as the basis for 

estimating the effects of the nicotine patch + nortriptyline. The 21-mg 

nicotine patch served as the highest patch dose in all study arms, and the 

nortriptyline dose was 75 mg per day in one arm and 100 mg per day in 

the other arm. Both medications were used for standard durations (8–14 

weeks).

 Nicotine Patch + Second Generation Antidepressants

Three studies yielded three analyzable arms that served as the basis for 

estimating the effects of second generation antidepressants + the nicotine 

patch. The antidepressants used included the specific serotonin re-uptake 

inhibitor paroxetine (20 mg per day for 9 weeks for 2 arms), and the atypical antidepressant venlafaxine (22 mg per day for 21 weeks). The 21- or 

22-mg patch served as the highest patch dose, with the duration of patch 

therapy being 6 or 8 weeks.
Treating Tobacco Use and Dependence: 2008 Update

120

 Effectiveness of Medication Combinations

Table 6.26 displays the 2008 meta-analytic results describing the effectiveness data for the five medication combinations. The data reveal that the 

nicotine patch + bupropion SR, the nicotine patch + inhaler, the long-term 

nicotine patch + ad libitum NRT, the nicotine patch + nortriptyline, and 

the nicotine patch + second generation antidepressants all significantly 

increased a smoker’s likelihood of abstinence relative to placebo treatment. 

A meta-analysis using 12-month abstinence rates had similar results. The 

first three medication combinations involve only first-line medications and 

therefore are recommended for use as first-line treatments. 

Decisions about use of a medication combination may be based on considerations other than abstinence. Evidence indicates, for instance, that a 

combination of medication may result in greater suppression of tobacco 

withdrawal symptoms than does the use of a single medication.148,315,316 

Patient preferences also may play a role, because some combinations of 

medications may produce more side effects and cost more than individual 

medications.315,317,318

Relative Effectiveness of Medications

Information on the relative effectiveness of medications may help the 

clinician and patient select an appropriate medication intervention. To 

this end, all medication conditions in Table 6.26 were compared with the 

nicotine patch. The nicotine patch was selected as a comparison condition 

because more study arms were available for this condition than for any 

other, and because this condition was of moderate effectiveness relative 

to other conditions (see Table 6.26; OR = 1.9). Contrasts between all 

treatments were not conducted because of concerns about Type I error 

due to multiple testing. Also, a conservative Hochberg319 adjustment to 

the alpha level was used so that only treatments that were substantially 

different in effectiveness would be found to be significantly different. These 

comparisons of the different medications should be viewed as suggestive 

rather than definitive. For instance, the studies of one type of medication 

may differ from studies evaluating a different medication on numerous 

bases such as year of publication, type of population, and newness of the 

medication. It is possible that such differences could have affected the 

relative size of the odds ratios obtained for the different medications. 

Existing studies that provide head-to-head comparisons of medications 
Evidence and Recommendations

121

(which were included in this meta-analysis) provide an additional source 

of information on this topic.

The a posteriori tests resulted in three treatment conditions being statistically different from the effectiveness of the nicotine patch when it is used at 

regular doses and durations. The 2 mg per day varenicline and the combination of long-term patch use + ad libitum NRT (gum or spray) were both 

found to produce significantly greater likelihood of long-term abstinence 

than the patch by itself (see Table 6.28). Two treatments produced a lower 

likelihood of long-term abstinence: selective serotonin re-uptake inhibitors (SSRIs) and naltrexone. The analyses presented in Table 6.28 represent 

6-month abstinence rates. Similar conclusions were reached in a metaanalysis of 12-month abstinence rates.

Table 6.28. Meta-analysis (2008): Effectiveness of and abstinence rates of medications relative to the nicotine patch (n = 83 studies)a

Medication Number of 

arms

Estimated odds ratio 

(95% C. I.)

Nicotine Patch (reference group) 32 1.0

Monotherapies

Varenicline (2 mg/day) 5 1.6 (1.3–2.0)

Nicotine Nasal Spray 4 1.2 (0.9–1.6)

High-Dose Nicotine Patch ( > 25 mg; standard or long-term) 4 1.2 (0.9–1.6)

Long-Term Nicotine Gum ( > 14 weeks) 6 1.2 (0.8–1.7)

Varenicline (1 mg/day) 3 1.1 (0.8–1.6)

Nicotine Inhaler 6 1.1 (0.8–1.5)

Clonidine 3 1.1 (0.6–2.0)

Bupropion SR 26 1.0 (0.9–1.2)

Long-Term Nicotine Patch ( > 14 weeks) 10 1.0 (0.9–1.2)

Nortriptyline 5 0.9 (0.6–1.4)

Nicotine Gum 15 0.8 (0.6–1.0)

Combination therapies

Patch (long-term; > 14 weeks) + NRT (gum 

or spray) 3 1.9 (1.3–2.7)

Patch + Bupropion SR 3 1.3 (1.0–1.8)
Treating Tobacco Use and Dependence: 2008 Update

122

Medication Number of 

arms

Estimated odds ratio 

(95% C. I.)

Combination therapies

Patch + Nortriptyline 2 0.9 (0.6–1.4)

Patch + Inhaler 2 1.1 (0.7–1.9)

Second-generation antidepressants & 

Patch 3 1.0 (0.6–1.7)

Medications not shown to be effective

Selective Serotonin Re-uptake Inhibitors 

(SSRIs) 3 0.5 (0.4–0.7)

Naltrexone 2 0.3 (0.1-0.6)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

 Precessation NRT Use

Recent studies have investigated the use of NRT prior to a quit attempt. 

Some of these studies involved smokers who are planning to quit, and 

others involved smokers who were not willing to quit but who were willing to reduce their smoking. The use of NRT while smoking contradicts 

NRT package inserts. The existence of multiple studies on this prequit 

medication strategy led the Panel to review this topic as part of this Guideline update. The results of this review (see below) suggest that NRT prior 

to quitting may be effective in increasing abstinence rates, but the Panel 

chose not to recommend this intervention (see below). If this strategy is 

used clinically, patients should be advised to cease NRT use if they develop 

symptoms of nicotine toxicity (e.g., nausea, vomiting, dizziness).

Precessation Use of NRT Among Patients Making a Quit Attempt. Two randomized controlled studies examined the effect of initiating the use of NRT 

prior to a quit attempt among patients making a quit attempt. One study 

examined the use of nicotine patches, either active or placebo, 2 weeks 

prior to quitting, after which all participants received active patches for 12 

weeks following the quit day.320 Results revealed no differences in adverse 

events, and smokers who had received the active patches during the prequit period were more likely to be abstinent at 6 months postquit. In a second study, Rose and colleagues321 found that precessation patch use significantly increased abstinence rates at 4 weeks postquit but not at 6 months. 

Table 6.28. Meta-analysis (2008): Effectiveness of and abstinence rates of medications relative to the nicotine patch (n = 83 studies)a (continued)
Evidence and Recommendations

123

Finally, a small pilot study found that prequit patch use was well tolerated 

by smokers wanting to quit.322 Given the limited data on this strategy, the 

Panel declined to recommend precessation use of NRT among patients 

making a quit attempt. However, this topic warrants further research. 

Use of NRT Among Patients Unwilling to Make a Quit Attempt at This Time.

Research has examined the use of NRT in patients who are not currently 

willing to make a quit attempt but who state that they are willing to reduce 

their smoking. In general, these studies found that NRT used in this way 

increased the likelihood that smokers will make a quit attempt and succeed 

in quitting. Sufficient studies were available to meta-analyze this topic for 

the Guideline update. Five studies generated five arms that met criteria for 

the analysis of the effect of NRT compared to placebo with smokers not 

willing to quit (but who were willing to reduce the number of cigarettes 

smoked and use a nicotine replacement medication). As Table 6.29 shows, 

the use of NRT more than doubled the likelihood that a smoker would be 

abstinent at 12 months, despite the smoker’s unwillingness to make a quit 

attempt at the time of initial assessment. The nicotine replacement products in these studies included nicotine gum (2 or 4 mg for 6–12 months), 

the nicotine inhaler (10 mg for 6–24 months), the nicotine patch (16-hour 

15-mg patch for up to 6 months), or the choice of a combination of these 

medications. 

Because of the selective participant inclusion criteria and other aspects of 

this research, it is unclear that the results described above would be relevant to the broader population of smokers unwilling to quit. For instance, 

most patients in the studies included in the analysis in Table 6.29 were not 

offered a cessation intervention prior to study induction. It is possible that 

some of the participants would have opted for a free cessation treatment 

had it been offered. Also, in some instances, the recruitment material may 

have made it clear that treatment was available only for those uninterested in quitting. It is unclear how this perceived contingency affected the 

sample. Further, it is not clear if the results would be true for only those 

interested in reducing their smoking and not for uninterested patients, in 

general. Additionally, there was concern that if clinicians routinely asked 

about interest in cutting down, this might suggest to tobacco users that 

reduction confers health benefits, is a recommended strategy for persons 

trying to quit, or is a recommended goal of treatment (rather than quitting 

smoking)—and that these perceptions might decrease the proportion of 

smokers willing to make a quit attempt. Because of such concerns, the Panel 
Treating Tobacco Use and Dependence: 2008 Update

124

decided not to recommend medication use as a standard intervention for 

smokers unwilling to quit. A recent Cochrane analysis323 found that NRT 

significantly increased quit rates among smokers not initially motivated to 

quit. The authors concluded, however, that there was insufficient evidence 

to recommend this as a standard treatment approach with this population. 

The Panel believes that this topic warrants further research.

Table 6.29. Meta-analysis (2008): Effectiveness of and abstinence rates for smokers 

not willing to quit (but willing to change their smoking patterns or reduce their 

smoking) after receiving NRT compared to placebo (n = 5 studies)a

Intervention Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

Placebo 5 1.0 3.6

Nicotine replacement (gum, inhaler, 

or patch)

5 2.5 (1.7–3.7) 8.4 (5.9–12.0)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Medications Not Recommended by the 

Guideline Panel

 Antidepressants Other Than Bupropion SR and 

 Nortriptyline

Smoking is significantly more prevalent among individuals with a past 

history of depression, and these individuals have more difficulty quitting 

smoking than do smokers without a past history of depression.324-328 One 

antidepressant, bupropion SR, has been documented as effective for 

treating tobacco use and approved by the FDA for this use (see Bupropion 

SR [sustained release], page 110). Nortriptyline also has been documented 

to be effective (see Nortriptyline, page 117), although the FDA has not 

evaluated this medication for treatment of tobacco dependence. The Panel’s 

review of the extant literature revealed a sufficient body of research to 

evaluate one class of antidepressants that is dissimilar from both bupropion 

SR and nortriptyline: selective serotonin re-uptake inhibitors (SSRIs).
Evidence and Recommendations

125

 Selective Serotonin Re-Uptake Inhibitors (SSRIs)

Two studies yielded three analyzable arms that served as the basis for 

estimating the effects of SSRIs. Sertraline (200 mg per day) served as the 

medication in one arm, and fluoxetine (30 to 60 mg per day) served as the 

medication in the other two arms. The treatment duration was 10 weeks 

in all arms. Results showed that treatment with SSRIs did not significantly 

increase the likelihood of abstinence relative to placebo treatment. These 

results are consistent with other independent reviews299 (see Table 6.26).

 Anxiolytics/Benzodiazepines/Beta-Blockers

A few trials have evaluated anxiolytics and other agents that reduce the 

somatic signs or the symptoms of anxiety. Early individual trials of propranolol, a beta-blocker,329 and diazepam, an anxiolytic,330 did not reveal a 

beneficial effect for these drugs compared with control interventions. Likewise, of the early studies assessing the anxiolytic buspirone that met inclusion criteria, only one revealed evidence of effectiveness relative to placebo.331 Further studies of buspirone have failed to replicate this effect.332-334

These results are consistent with other independent reviews.333 Because of 

a lack of data, no meta-analyses were conducted, and no conclusions were 

drawn regarding the effectiveness of anxiolytics in smoking cessation.

 Opioid Antagonists/Naltrexone

Two studies yielded the analyzable study arms that served as the basis for 

estimating the effects of the opiate antagonist naltrexone. Table 6.26 reveals 

that naltrexone treatment did not increase the likelihood of abstinence 

relative to placebo treatment. These results are consistent with other independent reviews.335 Two studies336,337 also examined whether naltrexone 

added to the effectiveness of the nicotine patch. The studies used different 

naltrexone and patch dosing regimens. The patch use regimen in one study 

did not meet meta-analysis inclusion criteria. Therefore, these patch + 

naltrexone studies could not be submitted to meta-analysis. Neither study 

reported significant benefit from adding naltrexone to the nicotine patch.
Treating Tobacco Use and Dependence: 2008 Update

126

 Silver Acetate

Due to limitations of the literature available regarding silver acetate, this 

agent was not included in the inclusive meta-analysis. Several randomized 

clinical trials338-340 of silver acetate, however, revealed no beneficial effects 

for smoking cessation; a Cochrane review concurs with this finding.341

 Mecamylamine

In the single study that compared mecamylamine alone to placebo, no 

effectiveness was noted.342 Another early study compared a combination of 

mecamylamine plus the nicotine patch to placebo and found a significant 

effect for this combination.343 A more recent study comparing nicotine 

patch alone to nicotine patch plus mecamylamine found no significant 

differences.344 These findings are consistent with other independent reviews.345 Because of these findings, the Panel drew no conclusions regarding mecamylamine as a monotherapy.

 Extended Use of Medications

For some patients, it may be appropriate to continue medication treatment 

for periods longer than is usually recommended. Results of the inclusive 

meta-analysis indicated that long-term patch and gum use are effective. Evidence indicates that the long-term use of gum may be more effective than 

a shorter course of gum therapy (Table 6.26). The Lung Health Study, of 

almost 4,000 smokers with evidence of early COPD, reported that approximately one-third of long-term quitters still were using nicotine gum at 12 

months,346 and some for as long as 5 years, with no serious side effects.347

Other studies also have found that, among patients given free access to 

nicotine gum, 15 to 20 percent of successful abstainers continue to use the 

gum for a year or longer.348 Thus, it may be that certain groups of smokers 

may benefit from long-term medication use. Although weaning should be 

encouraged for all patients using medications, continued use of such medication clearly is preferable to a return to smoking with respect to health 

consequences. This is because, unlike smoking, these medications do not 

(a) contain non-nicotine toxic substances (e.g., “tar,” carbon monoxide, 

formaldehyde, benzene); (b) produce sharp surges in blood nicotine levels; 

and/or (c) produce strong dependence.349,350 Finally, it should be noted that 

the medication treatment that produced the largest effects on abstinence 

rates, of those analyzed, involved long-term nicotine patch therapy + ad 

libitum NRT (Table 6.26).
Evidence and Recommendations

127

 Use of NRT in Cardiovascular Patients

Soon after the nicotine patch was released, the media reported a possible 

link between the use of this medication and cardiovascular risk. This question has been studied systematically since that time. Separate analyses now 

have documented the lack of an association between the nicotine patch 

and acute cardiovascular events,351-356 even in patients who continued to 

smoke while on the nicotine patch,357 although a recent study raised questions regarding NRT use in intensive care units.358 Because of inaccurate 

media coverage in the past, it may be important to inform patients who are 

reluctant to use NRTs that there is no evidence of increased cardiovascular 

risk with these medications. Note that package inserts recommend caution 

in patients with acute cardiovascular diseases (see Tables 3.3–3.11).

 Future Research

The following pharmacotherapeutic topics require additional research:

•	 Relative effectiveness and safety of the seven FDA-approved medications, in general and for specific subpopulations (e.g., women; adolescents; older smokers; smokeless tobacco users; individuals with psychiatric disorders, including substance use disorders; postmyocardial 

infarction patients) and for long-term treatment

•	 Use of combined tobacco dependence medications in general and for

specific subpopulations (e.g., highly dependent smokers)

•	 Effectiveness of long-term medications

•	 Effectiveness of prequit NRT use in increasing abstinence rates

•	 Strategies to address widespread misconceptions about effective smoking cessation medications and common barriers to their appropriate 

use

•	 Effectiveness of MAO inhibitors, especially for those with depression
Treating Tobacco Use and Dependence: 2008 Update

128

Use of Over-the-Counter Medications

Recommendation: Over-the-counter nicotine patch therapy is more 

effective than placebo, and its use should be encouraged. (Strength of 

evidence = B)

No new studies were identified for the 2008 update that examined the 

effectiveness of nicotine patch versus placebo patch in an OTC setting. 

Based on the 2000 Guideline, there were three placebo-controlled 

studies with six arms that met selection criteria for the meta-analysis of 

medication interventions in OTC settings. These three studies specifically 

examined the effect of patch versus placebo. The only additional treatments 

in these studies were a self-help manual, instructions contained in the 

package, or written directions for using the patch. As shown in Table 6.30, 

the use of the nicotine patch in OTC settings nearly doubles abstinence 

rates when compared to a placebo. These results are consistent with a 

more recent (2003) meta-analysis of active versus placebo patch in an 

OTC setting that found an odds ratio of 2.5 (95% C.I. = 1.8–3.6) for active 

nicotine patch.359 A study that did not meet inclusion criteria for metaanalysis reported low abstinence rates when the nicotine patch was used in 

the OTC setting.360 Too few studies were done in the OTC setting to permit 

meta-analysis of the OTC effect of any other medication. The “B” strength 

of evidence rating reflects the Panel’s concern about the external validity of 

the studies designed to reflect the OTC context. 

The FDA has approved nicotine gum, the nicotine lozenge, and the nicotine patch for OTC use. The patches and gum are identical to those previously available only via prescription. Although the OTC status of these 

medications has increased their availability and use,361 this does not reduce 

the clinician’s responsibility to intervene with smokers or insurers/managed care organizations/payers to cover the costs of such treatment. Moreover, OTC availability may enhance the capacity of a broad array of clinicians to intervene comprehensively when treating tobacco dependence.

All clinicians have specific responsibilities regarding these products, such 

as encouraging their use when appropriate, identifying patients with specific contraindications, providing counseling and followup, encouraging total 

abstinence during a quit attempt, offering instruction on appropriate use, 

addressing common patient misconceptions, and providing prescriptions 
Evidence and Recommendations

129

when needed for select populations to ensure reimbursement (e.g., Medicaid patients). Additionally, patients should be urged to read the package insert and consult with their pharmacist. Finally, the clinician should advise 

patients regarding the selection and use of medications, whether purchased 

OTC or by prescription. Debate has arisen in the field regarding the effectiveness of OTC NRT use. For instance, a population-based study found 

no long-term effects of OTC nicotine patch use.34 However, cross-sectional 

surveys have methodolgical constraints (e.g., patients may self-select certain treatments based on dependence or perceived difficulty of quitting).362

Table 6.30. Meta-analysis (2000): Effectiveness of and estimated abstinence rates 

for OTC nicotine patch therapy (n = 3 studies)a

OTC therapy Number of 

arms Odds Ratio (95% C.I.) Estimated abstinence rate (95% C.I.)

Placebo 3 1.0 6.7

OTC nicotine 

patch therapy 3 1.8 (1.2–2.8) 11.8 (7.5–16.0)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

 Future Research

Important topics for future research are:

•	 Effectiveness of nicotine patch, gum, and lozenge when access is OTC

•	 Extent to which individuals use medications appropriately when access

is OTC

•	 Extent to which the effectiveness of OTC medication is enhanced by

other treatments (e.g., pharmacist counseling, telephone counseling, 

computer self-help resources, clinician interventions)

•	 Extent to which OTC status increases or reduces the use of medications by poor or minority populations 

•	 Strategies for improving the accessibility and appropriate use of OTC

medications
Treating Tobacco Use and Dependence: 2008 Update

130

C. Systems Evidence

Clinician Training and Reminder Systems

Recommendation: All clinicians and clinicians-in-training should be 

trained in effective strategies to assist tobacco users willing to make a 

quit attempt and to motivate those unwilling to quit. Training appears 

to be more effective when coupled with systems changes. (Strength of 

Evidence = B)

Meta-analyses were conducted to analyze the effects of clinician training 

and other systems changes. It was necessary to include studies in these 

analyses in which higher level units (clinicians or clinical sites) served as 

units of randomization. This strategy was adopted because relatively few 

studies in this area of research randomized individual patients to treatment 

or intervention conditions. Studies randomized at higher level units were 

considered for the analyses only if the study’s analytic plan accounted for 

the dependency of data nested under such units or if the outcome, such as 

providing advice to quit, was analyzed at the same level as the randomization (e.g., clinician or clinic level). In fact, however, the few studies that 

analyzed data at the level of the clinician or clinic shared no common outcomes and could not be used in the meta-analysis. 

Table 6.31 depicts meta-analytic results for studies that examined the 

effects of training on abstinence outcomes. Only two studies, somewhat 

heterogenous, were available for this analysis. Thus, although the metaanalysis showed a significant effect of training, the Panel elected to assign 

this recommendation a “B” strength of evidence.

Table 6.31. Meta-analysis (2008): Effectiveness of and estimated abstinence rates 

for clinician training (n = 2 studies)a

Intervention Number of 

arms

Odds Ratio 

(95% C.I.)

Estimated abstinence rate 

(95% C.I.)

No intervention 2 1.0 6.4

Clinician training 2 2.0 (1.2–3.4) 12.0 (7.6–18.6)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Clinician training and other systems changes are intended to increase rates 

of tobacco use assessment and intervention. Therefore, additional metaanalyses were conducted to ascertain the effects of systems changes on 
Evidence and Recommendations

131

outcomes such as clinician assessment of smoking status (“Ask”), provision 

of treatment (“Assist”), and arranging for treatment followup (“Arrange”). 

Thus, these meta-analyses focused on systems change impact on specific 

clinician behaviors. In the analyzed studies, clinician behavior was assessed 

via patient report or chart review (not via clinician report). Analyses of 

such clinician behaviors are of public health significance because of evidence that the provision of treatment has been shown to lead to higher 

tobacco cessation rates.

As noted in Table 6.32, training clinicians increases the percentage of 

smokers who receive treatment, such as a discussion of benefits/obstacles 

to quitting or strategies to prevent relapse, medication, and provision of 

support. Further, combining clinician training with a charting system, such 

as chart reminder stickers or treatment algorithms attached to the chart, 

increases rates of tobacco use assessment (Table 6.33), setting a quit date 

(Table 6.34), providing materials (Table 6.35), and arranging for followup 

(Table 6.36). Thus, clinician training, especially when coupled with other 

systems changes such as reminder systems, increases the rates at which 

clinicians engage in tobacco interventions that reliably boost tobacco cessation. The Guide to Community Preventive Services92 found insufficient evidence to recommend provider education systems as stand-alone interventions, separate from other system changes, but does recommend provider 

education when part of other system changes such as reminder systems.

Table 6.32. Meta-analysis (2008): Effectiveness of clinician training on rates of 

providing treatment (“Assist”) (n = 2 studies)a

Intervention Number of 

arms

Odds Ratio 

(95% C.I.) Estimated rate (95% C.I.)

No intervention 2 1.0 36.2

Clinician training 2 3.2 (2.0–5.2) 64.7 (53.1–74.8)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Table 6.33. Meta-analysis (2008): Effectiveness of clinician training combined with 

charting on asking about smoking status (“Ask”) (n = 3 studies)a

Intervention Number of 

arms

Odds Ratio (95% 

C.I.) Estimated rate (95% C.I.)

No intervention 3 1.0 58.8

Training and 

charting 3 2.1 (1.9–2.4) 75.2 (72.7–77.6)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.
Treating Tobacco Use and Dependence: 2008 Update

132

Table 6.34. Meta-analysis (2008): Effectiveness of training combined with charting 

on setting a quit date (“Assist”) (n = 2 studies)a

Intervention Number of 

arms

Odds Ratio 

(95% C.I.) Estimated rate (95% C.I.)

No intervention 2 1.0 11.4

Training and 

charting 2 5.5 (4.1–7.4) 41.4 (34.4–48.8)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Table 6.35. Meta-analysis (2008): Effectiveness of training combined with charting 

on providing materials (“Assist”) (n = 2 studies)a

Intervention Number of 

arms

Odds Ratio 

(95% C.I.)

Estimated rate 

(95% C.I.)

No intervention 2 1.0 8.7

Training and 

charting 2 4.2 (3.4–5.3) 28.6 (24.3–33.4)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Table 6.36. Meta-analysis (2008): Effectiveness of training combined with charting 

on arranging for followup (“Arrange”) (n = 2 studies)a

Intervention Number of 

arms

Odds Ratio 

(95% C.I.) Estimated rate (95% C.I.)

No intervention 2 1.0 6.7

Training and 

charting 2 2.7 (1.9–3.9) 16.3 (11.8– 22.1)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

These meta-analyses support the finding that clinician training increases 

the delivery of effective tobacco use treatments. Training elements provided in these interventions included didactic presentation of material, 

group discussions, and role playing. These studies also examined a range of 

clinician training, from formal training during residency to onsite clinician 

training within the community.

Training should be directed at both clinicians-in-training as well as practicing clinicians. Training should be reinforced throughout the clinicians’ 

education and practice.363-368 Such training has been shown to be cost-effective.369 For clinicians-in-training, most clinical disciplines currently neither 
Evidence and Recommendations

133

provide training nor require competency in tobacco use interventions,370

although this is improving slowly.371,372 One survey of U.S. medical schools 

found that most medical schools (69%) did not require clinical training in 

tobacco dependence treatment.373 The National Cancer Institute’s Prevention and Cessation Education in Medical Schools (PACE) reported that, in 

2004, about 36 percent of medical school courses offered about 10 hours of 

tobacco-related teaching over 4 years,374 and PACE has developed competencies for graduating medical students.375

Similarly, the American Dental Education Association has guidelines recommending tobacco use cessation clinical activities (TUCCA) education 

for dental and dental hygiene students and, in 1998, 51 percent of dental 

schools reported clinical training in this area.376 Tobacco-related curricula 

may be taught as part of a preventive medicine or substance abuse course 

or as a class by itself. Similar recommendations would be relevant to virtually all other clinical disciplines. Training in tobacco use interventions 

should not only transmit essential treatment skills (see Chapter 3), but also 

should inculcate the belief that tobacco dependence treatment is a standard 

of good clinical practice.130,208,250

Several factors would promote the training of clinicians in tobacco intervention activities:370

•	 Inclusion of education and training in tobacco dependence treatments

in the required curricula of all clinical disciplines

•	 Evaluation of effective tobacco dependence treatment knowledge and

skills in licensing and certification exams for all clinical disciplines

•	Adoption by medical specialty societies of a uniform standard of competence in tobacco dependence treatment for all members

Finally, clinicians who currently use any tobacco product should participate in treatment programs to stop their own tobacco use permanently. 

Clinicians are important role models for their patients, and those who use 

tobacco probably are less likely to counsel their patients to quit.377 Therefore, it is heartening that many types of clinicians have dramatically 

decreased their own tobacco use during the past 40 years,378 although this 

has not been universal.
Treating Tobacco Use and Dependence: 2008 Update

134

 Future Research

The following topics regarding clinician training require additional 

research:

•	 Effectiveness of training programs for other health disciplines, such as

nursing, psychology, dentistry (including hygienists), social work, and 

pharmacy

•	 Effective elements in successful training programs (e.g., continuing

medical education, interactive components)

•	 Combined effect of multiple systems changes, such as clinician training, reminder systems, clinician feedback, incentive payments, and 

recruitment of opinion leaders 

Cost-Effectiveness of Tobacco Dependence 

Interventions

Recommendation: The tobacco dependence treatments shown to be 

effective in this Guideline (both counseling and medication) are highly 

cost-effective relative to other reimbursed treatments and should be 

provided to all smokers. (Strength of Evidence = A)

Recommendation: Sufficient resources should be allocated for systems 

support to ensure the delivery of efficacious tobacco use treatments. 

(Strength of Evidence = C)

Smoking exacts a substantial financial burden on the United States. A 

recent report of the Centers for Disease Control and Prevention estimated 

that tobacco dependence costs the Nation more than $96 billion per year in 

direct medical expenses and $97 billion in lost productivity.28 Given these 

substantial costs, research has focused on the economic impact and costeffectiveness of tobacco cessation interventions.

Tobacco use treatments, ranging from brief clinician advice to specialistdelivered intensive programs, including medication, have been shown 

not only to be clinically effective, but also to be extremely cost-effective 

relative to other commonly used disease prevention interventions and 
Evidence and Recommendations

135

medical treatments. Cost-effectiveness analyses have shown that tobacco 

dependence treatment compares favorably with routinely reimbursed 

medical interventions such as the treatment of hypertension and hypercholesterolemia, as well as preventive screening interventions such as periodic 

mammography or Papanicolaou smears.222,224,379-382 For example, the cost 

per life-year saved of tobacco dependence treatment has been estimated at 

$3,539,194 which compares favorably to hypertension screening for men ages 

45 to 54 ($5,200) and annual cervical screening for women ages 34 to 39 

($4,100).383 Treating tobacco dependence also is important economically in 

that it can prevent the development of a variety of costly chronic diseases, 

including heart disease, cancer, and pulmonary disease. In fact, tobacco 

dependence treatment has been referred to as the “gold standard” of health 

care cost-effectiveness.225

Cost-effectiveness can be measured in a variety of ways, including cost per 

quality-adjusted-life-year saved (QALY), cost per quit, health care costs 

and utilization pre- and postquit, and return on investment (ROI) for coverage of tobacco dependence treatment.

Cost per Quality-Adjusted-Life-Year Saved and 

Cost per Quit 

Numerous analyses have estimated the cost per QALY saved resulting from 

use of effective tobacco dependence interventions.187,222,380,384-389 In general, 

evidence-based tobacco use interventions compare favorably with other 

prevention and chronic disease interventions such as treatment of hypertension and mammography screening when using this criterion. Specific 

analyses have estimated the costs of tobacco use treatment to range from 

a few hundred to a few thousand dollars per QALY saved.228,385 Separate 

analyses have computed the estimated costs of treatment in terms of the 

cost per quit. Compared to other interventions, the cost of tobacco use 

treatments has been modest, ranging from a few hundred to a few thousand dollars per quit.194,212,384,390-393

Managed Care Organizations (MCOs) often assess the per member per 

month (PMPM) cost of a benefit, and the PMPM cost for tobacco use 

treatment has been assessed in a variety of settings. In general, the PMPM 

cost for tobacco use treatments has been low relative to other covered benefits, ranging from about $0.20 to about $0.80 PMPM.210,228,391,394
Treating Tobacco Use and Dependence: 2008 Update

136

Health Care Costs and Utilization Pre- and 

Postquit 

A substantial body of research has investigated the effect of tobacco use 

treatment on health care costs.395-399 A synthesis of these findings suggests that: (1) among individuals who quit tobacco use, health care costs 

typically increase during the year in which smokers quit then decline 

progressively, falling below those of continuing smokers for 1 to 10 years 

after quitting; (2) in general, smokers’ health care costs begin to rise in the 

time period immediately prior to quit attempts; and (3) higher health care 

utilization predicts smoking cessation among smokers with and without 

chronic diseases. These findings suggest that quitting smoking often occurs in response to serious and expensive health problems. Such research 

also suggests that increases in health care costs, including hospitalizations, 

during the year of quitting may be a cause rather than a consequence of 

successful smoking cessation.

Return on Investment for Coverage of Tobacco 

Dependence Treatment

The ROI tool is used frequently to estimate the amount of time it takes for 

an expenditure to earn back some or all of its initial investment. The economic arguments supporting the decision to provide insurance coverage 

for tobacco use treatments would be enhanced if the costs of such coverage 

are modest compared to economic benefits resulting from successful cessation (reductions in health care expenditures, increased productivity, and/or 

other costs). 

Studies have documented that tobacco dependence treatments provide 

a timely return on investment when considered by the employer. Such 

analyses have concluded that providing coverage for tobacco use treatment 

for employees often produces substantial net financial savings through 

increased health care savings, increased productivity, reduced absenteeism, 

and reduced life insurance payouts.229,400-402

Financial savings are more difficult to attain for a health plan given factors such as member turnover, the difficulty of attributing reduced health 

care expenditures to tobacco dependence, and the absence of economic 

benefits resulting from productivity gains. Although most analyses have 
Evidence and Recommendations

137

not demonstrated cost savings, insurance coverage of evidence-based 

tobacco dependence treatments are highly cost-effective relative to other 

frequently paid-for health care services. One recent effort to simulate the 

financial implications of covering tobacco use treatments by MCOs found 

that at 5 years, coverage of tobacco use treatment cost an MCO a modest 

$0.61 PMPM, with quitters gaining an average of 7.1 years of life and a 

direct coverage cost of about $3,500 for each life-year saved.228 The authors 

concluded that coverage of such cost-effective tobacco use treatment programs by MCOs should be strongly encouraged. Another study examined 

the trend in health care costs for former smokers over 7 years postquitting 

compared to continuing smokers.395 The authors found that, by the seventh year, former smokers’ cumulative costs (including increased cost in 

the year they quit) were lower than those of continuing smokers. A more 

recent analysis concluded that at 10 years, the ROI of providing a comprehensive tobacco use treatment benefit, considering only health care costs, 

ranged from 75 percent to 92 percent, indicating that health care savings 

alone have repaid more than three-fourths of the investment.229 Other analyses have shown that multiple tobacco use treatment components, including 

telephone counseling and various medications,227,403,404 yield a favorable 

ROI. The American Health Insurance Plans (AHIP) has provided a Web 

link for health plans to compute their ROI for the provision of tobacco use 

treatment: www.businesscaseroi.org/roi/default.aspx.

Tobacco cessation treatment is particularly cost-effective in certain 

populations, such as hospitalized patients and pregnant women. For 

hospitalized patients, successful tobacco abstinence not only reduces 

general medical costs in the short term, but also reduces the number 

of future hospitalizations.9,355,405 Tobacco dependence interventions for 

pregnant women are especially cost-effective because they result in fewer 

low birth-weight babies and perinatal deaths; fewer physical, cognitive, and 

behavioral problems during infancy and childhood; and yield important 

health benefits for the mother.406,407 One study found that interventions 

with U.S. pregnant smokers could net savings up to $8 million in direct 

neonatal inpatient costs given the cost of an intervention ($24–$34) 

versus the costs saved ($881) for each woman who quits smoking during 

pregnancy.408 Another study showed that, for each low-income pregnant 

smoker who quit, Medicaid saved $1,274.409 A simulation study found that 

a 1 percent decrease in smoking prevalence among U.S. pregnant women 

would save $21 million (1995 dollars) in direct medical costs in the first 

year.406,410,411
Treating Tobacco Use and Dependence: 2008 Update

138

Tobacco Dependence Treatment as a Part of 

Assessing Health Care Quality

Recommendation: Provision of Guideline-based interventions to treat 

tobacco use and dependence should remain in standard ratings and 

measures of overall health care quality (e.g., NCQA HEDIS). These 

standard measures should also include measures of outcomes (e.g., 

use of cessation treatment, short- and long-term abstinence rates) that 

result from providing tobacco dependence interventions. (Strength of 

Evidence = C)

The provision of tobacco dependence treatment should be increased by: 

(1) attention to health organization “report cards” (e.g., HEDIS, The Joint 

Commission, Physician Consortium for Performance Improvement, 

National Quality Forum, Ambulatory Quality Alliance),89,412-414 which 

support smoker identification and treatment; (2) accreditation criteria 

used by The Joint Commission and other accrediting bodies that include 

the presence of effective tobacco assessment and intervention policies; and 

(3) increasing the use of tobacco-related measures in pay-for-performance 

initiatives.

Future Research

The following topics regarding cost-effectiveness and health systems 

require additional research:

•	 Cost-effectiveness of the various tobacco dependence treatments, both

short- and long-term

•	 Optimal ways to remove systemic barriers that prevent clinicians from

effectively delivering tobacco dependence treatments

•	 Systemic interventions to encourage provider and patient utilization of

effective tobacco dependence treatments

•	 Relative costs and economic impacts of different formats of effective

treatments (e.g., proactive telephone counseling, face-to-face contact, 

medication)
Evidence and Recommendations

139

•	 Impact of using tobacco intervention performance measures on clinician intervention and patient outcomes, including the use of such 

measures in “pay for performance” programs

Providing Treatment for Tobacco Use and 

Dependence as a Covered Benefit

Recommendation: Providing tobacco dependence treatments (both 

medication and counseling) as a paid or covered benefit by health 

insurance plans has been shown to increase the proportion of smokers who use cessation treatment, attempt to quit, and successfully quit. 

Therefore, treatments shown to be effective in the Guideline should be 

included as covered services in public and private health benefit plans. 

(Strength of Evidence = A) 

Multiple studies have assessed the impact of including tobacco dependence 

treatment as a covered health insurance benefit for smokers. Most studies 

have documented that such health insurance coverage increases both treatment utilization rates and the rates of cessation,210,212,391,415 although some 

research is not consistent with these findings.416 A recent Cochrane analysis 

(2005) concluded that health care financing systems that offered full payment for tobacco use treatment increased self-reported prolonged abstinence rates at relatively low costs when compared with a partial benefit or 

no benefit. Moreover, the presence of prepaid or discounted prescription 

drug benefits increases patients’ receipt of medication and smoking abstinence rates.231,348,417 These studies emphasize that removing all cost barriers 

yields the highest rates of treatment utilization. 

Three studies met criteria to be included in a 2008 Guideline update metaanalysis of the effects of providing tobacco use treatments as a covered 

health insurance benefit. Three different outcomes were examined: rates 

of treatment provision, quit attempts, and quit rates. As can be seen in 

Tables 6.37 through 6.39, compared to not having tobacco use treatment as 

a covered benefit, individuals with the benefit were more likely to receive 

treatment, make a quit attempt, and abstain from smoking.
Treating Tobacco Use and Dependence: 2008 Update

140

Table 6.37. Meta-analysis (2008): Estimated rates of intervention for individuals 

who received tobacco use interventions as a covered health insurance benefit 

(n = 3 studies)a

Treatment Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated intervention rate

(95% C.I.)

Individuals with 

no covered health 

insurance benefit

3 1.0 8.9 

Individuals with the 

benefit 3 2.3 (1.8–2.9) 18.2 (14.8–22.3)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Table 6.38. Meta-analysis (2008): Estimated rates of quit attempts for individuals 

who received tobacco use interventions as a covered health insurance benefit 

(n = 3 studies)a

Treatment Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated quit attempt rate

(95% C.I.)

Individuals with no 

covered benefit 3 1.0 30.5

Individuals with the 

benefit 3 1.3 (1.01–1.5) 36.2 (32.3–40.2)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Table 6.39. Meta-analysis (2008): Estimated abstinence rates for individuals who 

received tobacco use interventions as a covered benefit (n = 3 studies)a

Treatment Number of

arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate

(95% C.I.)

Individuals with no 

covered benefit 3 1.0 6.7

Individuals with 

the benefit 3 1.6 (1.2–2.2) 10.5 (8.1–13.5)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

It may be in the best interests of insurance companies, MCOs, purchasers, 

and governmental bodies within a specific geographic area to work collaboratively to ensure that tobacco dependence interventions are a covered 

benefit and that enrollees are aware of these benefits. This would allow the 

financial benefits of the successful use of these services to be realized by all 

of the health plans within a community.
Evidence and Recommendations

141

 Future Research

•	 Impact of promotion or communication of tobacco dependence

treatment benefits on utilization and resulting population health and 

economic effects

•	 Cost-effectiveness of specific elements of tobacco dependence treatment

•	Appropriate level of payment needed to optimize clinician delivery of

tobacco dependence treatment

143

 Chapter 7 Specific Populations and 

Other Topics

Background

Many factors could affect the acceptability, use, and effectiveness of tobacco 

dependence treatments. This raises the question of whether interventions 

should be tailored or modified on the basis of personal characteristics 

or contextual factors such as gender, race/ethnicity, age, comorbidity, 

or hospitalization status. Should pregnant smokers receive tobacco 

dependence medication? Do tobacco dependence interventions interfere 

with nontobacco chemical dependency treatments? These and other 

specific populations and issues are considered in this chapter. The answers 

to these questions are relevant to a range of clinicians who routinely deal 

with specific populations of smokers (e.g., obstetricians, gynecologists, 

pediatricians, psychiatrists, internists, cardiologists, nurses, pharmacists, 

dentists, and dental hygienists).

Recommendation: The interventions found to be effective in this Guideline have been shown to be effective in a variety of populations. In addition, many of the studies supporting these interventions comprised 

diverse samples of tobacco users. Therefore, interventions identified as 

effective in this Guideline are recommended for all individuals who use 

tobacco, except when medication use is contraindicated or with specific 

populations in which medication has not been shown to be effective 

(pregnant women, smokeless tobacco users, light smokers, and adolescents). (Strength of Evidence = B)

Effective Treatments for Specific Populations

The above recommendation applies to the broad population of smokers, 

including HIV-positive smokers; hospitalized smokers; lesbian/gay/bisexual/ 

transgender smokers; those with low socioeconomic status (SES)/limited 

formal education; smokers with medical comorbidities; older smokers; 

smokers with psychiatric disorders, including substance use disorders; 

racial and ethnic minorities; and women smokers. It does not apply to 

adolescents, pregnant smokers, light smokers, and smokeless tobacco users 

(see below). 
Treating Tobacco Use and Dependence: 2008 Update

144

The recommendation that tobacco dependence treatments be used with 

broad populations of tobacco users arises from several considerations. 

One is that many of the randomized trials that generated the treatment 

recommendations comprised diverse samples. A second consideration is 

that the studies that tested interventions in homogeneous, specific populations show that interventions that are effective in one population tend to 

be effective in other populations. Finally, the relative safety of the tobacco 

dependence treatments versus the hazards of continued tobacco use supports some extrapolation from extant data. Table 7.1 reviews the randomized clinical trial (RCT) evidence of effectiveness of various treatments in 

different populations. Unless specifically stated, this table presents evidence 

from individual, screened RCTs rather than from meta-analyses. It is not 

intended to provide a comprehensive review of the relevant literature, but 

rather to provide some key findings from that review. Importantly, adolescents, pregnant smokers, light smokers, and smokeless tobacco users each 

have their own sections of this Guideline update, given that they usually 

are excluded from the RCTs used to evaluate the effectiveness of interventions presented in this Guideline and may have other special issues (e.g., 

safety). 

Table 7.1. Evidence of effectiveness of tobacco dependence interventions in 

specific populations

Population of 

Smokers Review of Evidence

HIV-positive No long-term RCTs have examined the effectiveness of interventions in this population. More research is needed.

• One study with 3-month followup indicated that telephone counseling is promising.418

• Pilot data indicate that effective treatments work with this population.419

Hospitalized 

patients

2007 Cochrane analyses420 revealed that intensive intervention 

(inpatient contact plus followup for at least 1 month) was associated 

with a significantly higher quit rate compared to control conditions (OR = 1.65; 95% CI = 1.44–1.90, 17 trials). Specific additional 

Cochrane findings: 

• Posthospitalization followup appears to be a key component of 

effective interventions.

• No significant effect of medication was seen in this population. 

However, the effect sizes were comparable to those obtained in 

other clinical trials, suggesting that nicotine replacement therapy 

(NRT) and bupropion SR may be effective in this population.
Specific Populations and Other Topics

145

Population of 

Smokers Review of Evidence

Hospitalized 

patients

(continued)

• Intervention is effective regardless of the patient’s reason for 

admission. There was no strong evidence that clinical diagnosis of 

the medically comorbid condition affected the likelihood of quitting.

Interventions that have been shown to be effective in individual 

studies are: counseling and medication57,355,421-423 and other psychosocial interventions, including self-help via brochure or audio/

videotape; chart prompt reminding physician to advise smoking 

cessation; hospital counseling; and postdischarge counseling telephone calls.424,425 Some data suggest NRT might not be appropriate 

in intensive care patients.358

Lesbian, gay, 

bisexual, 

transgender

No long-term RCTs have examined the effectiveness of interventions specifically in this population. 

Low SES/

limited formal 

educationa

• Meta-analysis (2008): 5 studies met selection criteria and contributed to a 2008 Guideline meta-analysis comparing counseling vs. usual care or no counseling among individuals with low 

SES/limited formal education. Meta-analytic results showed that 

counseling is effective in treating smokers with low SES/limited 

formal education (OR = 1.42; 95% C.I. = 1.04–1.92) (Abstinence 

rate without counseling = 13.2%; with counseling, abstinence rate 

= 17.7% [95% C.I. = 13.7%–22.6%])

• Interventions included in the meta-analysis were motivational 

messages with and without telephone counseling for low-income 

mothers and low-income African Americans,172,426 proactive telephone counseling in addition to nicotine patches,427,428 tailored 

bedside counseling and followup for hospitalized African-American patients.429

Medical comorbidities 

 

Tobacco use treatments have been shown to be effective among 

smokers with a variety of comorbid medical conditions. The comorbid conditions and effective interventions include:

• Cardiovascular disease: psychosocial interventions;430-439 exercise;440,441 bupropion SR,439,442 but one study did not find significant 

long-term effects;443 nicotine patch, gum, or inhaler.439

• Lung/COPD patients: intensive cessation counseling,444 intensive 

behavioral (relapse prevention) program combined with nicotine 

replacement therapy,445 bupropion SR,446,447 nortriptyline,447 nicotine patch or inhaler.448

• Cancer: counseling and medication,251,449,450 motivational counseling.451

Table 7.1. Evidence of effectiveness of tobacco dependence interventions in 

specific populations (continued)
Treating Tobacco Use and Dependence: 2008 Update

146

Population of 

Smokers Review of Evidence

Older smokers • Research has demonstrated the effectiveness of the “4 A’s” (ask, 

advise, assist, and arrange followup) in patients ages 50 and older.452-454 Counseling interventions,455-457 physician advice,118,456 buddy support programs,458 age-tailored self-help materials,456,459-461

telephone counseling,460,461 and the nicotine patch454,462,463 all have 

been shown to be effective in treating tobacco use in adults 50 

and older. 

Psychiatric disorders, including substance 

use disordersa

• Meta-analysis (2008): Four studies met selection criteria and were 

relevant to a 2008 Guideline meta-analysis comparing antidepressants (bupropion SR and nortriptyline) vs. placebo for individuals 

with a past history of depression. Meta-analytic results showed 

that antidepressants, specifically bupropion SR and nortriptyline,

are effective in increasing long-term cessation rates in smokers 

with a past history of depression (OR = 3.42; 95% C.I. = 1.70–6.84;

abstinence rates = 29.9%, 95% C.I. = 17.5%–46.1%). Note that these 

studies typically included intensive psychosocial interventions for 

all participants.

• Although psychiatric disorders may place smokers at increased risk 

for relapse, such smokers can be helped by tobacco dependence 

treatments.464-468

• Some data suggest that bupropion SR and NRT may be effective 

for treating smoking in individuals with schizophrenia and may 

improve negative symptoms of schizophrenia and depressive 

symptoms.467,469-472 Data suggest that individuals on atypical antipsychotics may be more responsive to bupropion SR for treatment 

of tobacco dependence than those taking standard antipsychotics.472

• Current evidence is insufficient to determine whether smokers 

with psychiatric disorders benefit more from tobacco use treatments tailored to psychiatric disorder/symptoms than from standard treatments.266,473

• Evidence indicates that tobacco use interventions, both counseling 

and medication, are effective in treating smokers who are receiving 

treatment for chemical dependency.464,474-476

• There is little evidence that tobacco dependence interventions 

interfere with recovery from nontobacco chemical dependencies among patients who are in treatment for such dependencies.475,477-482 One study suggests that delivery of smoking cessation 

interventions concurrent with alcohol dependence interventions 

may compromise alcohol abstinence outcomes, although there 

was no difference in smoking abstinence rates.483

Table 7.1. Evidence of effectiveness of tobacco dependence interventions in 

specific populations (continued)
Specific Populations and Other Topics

147

Population of 

Smokers Review of Evidence

Psychiatric disorders, including substance 

use disordersa

(continued) 

• The use of varenicline has been associated with depressed mood, 

agitation, suicidal ideation, and suicide. The FDA recommends that

patients tell their health care provider about any history of psychiatric illness prior to starting varenicline and that clinicians monitor 

for changes in mood and behavior when prescribing this medication. In light of these FDA recommendations, clinicians should 

consider eliciting information on their patients’ psychiatric history. 

For more information, see the FDA package insert.

Racial/ethnic 

minorities

RCTs have examined the effectiveness of interventions in specific 

racial/ethnic minority populations:

African Americans

• Bupropion SR,484 in-person motivational counseling,176 nicotine 

patch,485 clinician advice,486,487 counseling,488 biomedical feedback,489 tailored self-help manuals and materials, and telephone 

counseling486,490 have been shown to be effective with AfricanAmerican smokers. 

Asian and Pacific Islanders

• No long-term RCTs have examined the effectiveness of interventions specifically in this population. 

Hispanics

• Nicotine patch;491 telephone counseling;492 self-help materials, including a mood management component;493 and tailoring494 have 

been shown to be effective with Hispanic smokers. 

American Indians and Alaska Natives

• Screening for tobacco use, clinician advice, clinic staff reinforcement, and followup materials have been shown to be effective for 

American Indian and Alaska Native populations.495

Women • Evidence shows that both men and women benefit from bupropion SR, NRT, and varenicline;496 evidence is mixed as to whether 

women show as great a benefit from NRT as do men.150,155-157,496-498

• Psychosocial interventions, including proactive phone counseling462 individually tailored followup,499 and advice to quit geared 

toward children’s health500 are effective with women. There is some 

evidence that exercise is effective for women;501 however, these 

findings are not consistent.502

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Table 7.1. Evidence of effectiveness of tobacco dependence interventions in 

specific populations (continued)
Treating Tobacco Use and Dependence: 2008 Update

148

Clinical Issues for Specific Populations

There are population-specific concerns and clinical issues regarding prevalence and treatment of tobacco dependence (see Table 7.2).

Table 7.2. Clinical issues for treating specific populations

Issue Approach

Language • Ensure that interventions are provided in a language the patient 

understands. Most quitlines provide counseling in Spanish, and 

some provide counseling in other languages.503

• All textual materials used (e.g., self-help brochures) should be written at an appropriate reading level. This is particularly important

given epidemiological data showing that tobacco use rates are 

markedly higher among individuals of lower educational attainment.504,505

Culture • Interventions should be culturally appropriate to be relevant and 

acceptable to the patient.506 The extent to which cultural tailoring 

enhances intervention effectiveness requires further research.490

• Clinicians should remain sensitive to individual differences and 

spiritual and health beliefs that may affect treatment acceptance, 

use, and success in all populations (see Chapter 6A, Specialized 

Assessment). 

Medical comorbidity• Examine the possibility of medication interactions (See Chapter 

6B, Interactions of First-Line Tobacco Use Medications With Other 

Drugs).308

• Address how exposure to tobacco can alter the liver’s ability to

metabolize different medications (HIV-positive patients).

HIV-Positive Smokers

HIV-positive individuals are more likely to smoke than the general population.507-510 Currently, HIV-positive individuals are living longer, due to 

treatment advances, making the issue of cigarette smoking in this population a significant clinical concern.511,512 HIV-positive smokers have higher 

mortality rates and report lower quality of life than HIV-positive nonsmokers.513,516 In addition, HIV-positive smokers appear to be at greater risk for 

developing invasive pneumococcal diseases and CNS infections compared 

with non-HIV infected individuals.514,517 Also, compared to nonsmoking 

HIV-positive individuals, smoking among HIV-positive persons is associated with increased risk of several opportunistic infections518-520 and 

spontaneous pneumothorax.521 Data suggest that HIV-positive smokers 

underestimate the effects of smoking on their health, and some state that 
Specific Populations and Other Topics

149

they will not live long enough for the health effects of smoking to matter.507,522 In addition, some HIV-positive smokers report that smoking is an 

effective way to cope with the stress of their illness.522

 Future Research

The following topics regarding HIV-positive smokers require additional 

research:

• Effectiveness of medications and counseling/behavioral interventions, 

including tailored interventions

• Effectiveness of motivational interviewing and educational approaches 

in increasing motivation to quit

• Effectiveness of community and social support networks in bolstering 

quitting motivation and improving treatment outcomes

Hospitalized Smokers

It is vital that hospitalized patients attempt to quit using tobacco because 

tobacco use may interfere with their recovery and overall health. Among 

cardiac patients, second heart attacks are more common in those who continue to smoke.9,523 Lung, head, and neck cancer patients who are successfully treated for their cancer but who continue to smoke are at elevated risk 

for a second cancer.524-531 Additionally, smoking negatively affects COPD as 

well as bone and wound healing.531-538

Hospitalized patients may be particularly motivated to make a quit attempt for two reasons. First, the illness resulting in hospitalization may 

have been caused or exacerbated by tobacco use, highlighting the patient’s 

perceived vulnerability to the health risks of smoking539 and making the 

hospitalization a “teachable moment.” Second, every hospital in the United 

States must now be smoke-free if it is to be accredited by The Joint Commission. As a result, every hospitalized smoker is temporarily housed in a 

smoke-free environment. In addition, more hospitals are adopting policies establishing tobacco-free campuses, thus extending smoke-free space 

from indoor facilities to surrounding outdoor environments.540-542 For these 

reasons, clinicians should use hospitalization as an opportunity to promote smoking cessation.11,543,544 This also is an opportunity for clinicians to 
Treating Tobacco Use and Dependence: 2008 Update

150

prescribe medications to alleviate withdrawal symptoms. If patients have 

positive experiences with the alleviation of their withdrawal symptoms, 

they may be more likely to use intensive treatments in a future quit attempt 

or maintain their hospital-enforced abstinence. Patients in long-term care 

facilities also should receive tobacco dependence interventions identified 

as effective in this Guideline. Suggested interventions for hospitalized patients can be found in Table 7.3.

Table 7.3. Suggested interventions for hospitalized patients

For every hospitalized patient, the following steps should be taken:

• Ask each patient on admission if he or she uses tobacco and document tobacco use 

status.

• For current tobacco users, list tobacco use status on the admission problem list and 

as a discharge diagnosis.

• Use counseling and medications to help all tobacco users maintain abstinence and 

to treat withdrawal symptoms.

• Provide advice and assistance on how to quit during hospitalization and remain 

abstinent after discharge.

• Arrange for followup regarding smoking status. Supportive contact should be provided for at least a month after discharge.

The importance of posthospitalization followup has been demonstrated by 

research.355,545-546 However, there are systems-level issues that may complicate the ability of hospital-based clinicians to follow up with smoking 

patients. The development of fax-to-quit links with quitline services may 

be an effective and efficient way for hospitals to refer patients for smoking 

cessation followup.195,199,547

 Future Research

The following topics regarding hospitalized patients require additional 

research:

•	 Effectiveness of interventions provided by different hospital personnel,

including nurses and respiratory therapists

•	 Effectiveness of counseling and medications with hospitalized patients

•	 Relapse prevention once the patient leaves the hospital, including use 

of fax-to-quit programs
Specific Populations and Other Topics

151

Lesbian/Gay/Bisexual/Transgender (LGBT) 

Smokers

LGBT individuals, both adolescents and adults, are more likely to smoke 

than the general population,548-550 and tobacco marketing is targeted at 

these communities.551-554 LGBT individuals are more likely to have other 

risk factors for smoking, including daily stress related to prejudice and 

stigma.555-558

 Future Research

The following topics regarding LGBT smokers require additional research:

•	Accessibility and acceptability of tobacco dependence interventions

•	 Rates of intervention use and effectiveness of both medications and

counseling treatments, including quitlines

•	 Effectiveness of tailored interventions

Low SES/Limited Formal Education

Individuals with low SES and/or limited formal education, including the 

homeless, bear a disproportionate burden from tobacco.559 Addressing 

this particular disparity is an important part of improving the overall 

health of the American public.560 These patients are more likely to: 

smoke,561,562 have limited access to effective treatment,563,564 be misinformed 

about smoking cessation medications,565 be exposed to more permissive 

environmental and workplace smoking policies,562 and be targeted by 

tobacco companies.566 They are less likely to receive cessation assistance.564

Moreover, smokers with low SES/limited formal education are more likely 

to be uninsured or on Medicaid than are other smokers.567 Only 25 percent 

of smokers on Medicaid reported receiving any practical assistance with 

quitting. However, low SES smokers or those with limited formal education 

express significant interest in quitting404,507,508,568 and appear to benefit from 

treatment.569,570 Due to the prevalence of smoking in this population, it is 

vital that clinicians intervene with such individuals. It is important that 

interventions, particularly written materials, be delivered in a manner that 

is understandable to the patient.
Treating Tobacco Use and Dependence: 2008 Update

152

 Future Research

The following topics regarding low SES/limited formal education smokers 

require additional research:

•	 Effectiveness of and compliance with medications shown to be effective with general populations of smokers

•	 Effectiveness and utilization of novel treatment delivery settings (e.g.,

pharmacy-based, community-based, worksite)

•	 Effectiveness of quitlines, including ability of this population to access

services using this modality

•	 Strategies for addressing misconceptions about effective cessation

treatment that may be more common in these populations

•	 Cost-effectiveness of cessation interventions delivered as part of

chronic disease management programs

Medical Comorbid Conditions, Including Cancer, 

Cardiac Disease, COPD, Diabetes, and Asthma

Smokers with comorbid medical conditions such as cancer, cardiac 

disease, COPD, diabetes, and asthma are important to target for tobacco 

use treatments, given the role that smoking plays in exacerbating these 

conditions.447,538,571-581 Clinicians treating smokers with these conditions 

have an ideal “teachable moment” in that they are treating a disease 

that may have been caused or exacerbated by smoking and that can 

be ameliorated by quitting198,582-588 but not by cutting down. Using 

chronic disease management programs to integrate tobacco dependence 

interventions into treatment may be an effective and efficient way to deliver 

tobacco use interventions to these populations.

 Future Research

The following topics regarding smokers with comorbid medical conditions 

require additional research:

•	 Effectiveness of counseling and cessation medications among individuals with diabetes and asthma
Specific Populations and Other Topics

153

•	 Impact and effectiveness of specialized assessment and tailored interventions in these populations

Older Smokers

It is estimated that more than 18 million Americans age 45 and older 

smoke cigarettes, accounting for 41 percent of all adult smokers in the 

United States;589 4.5 million adults over age 65 smoke cigarettes.590 Even 

smokers over the age of 65 can benefit greatly from abstinence.9,405,523,591

Older smokers who quit can reduce their risk of death from coronary 

heart disease, COPD, and lung cancer and decrease their risk of osteoporosis.544,592,593 Moreover, abstinence can promote more rapid recovery from 

illnesses that are exacerbated by smoking and can improve cerebral circulation.453,594,595 In fact, age does not appear to diminish the desire to quit596 or 

the benefits of quitting smoking,166,597 and treatments shown to be effective 

in this Guideline have been shown to be effective in older smokers (see 

Table 7.1). However, smokers over the age of 65 may be less likely to receive 

smoking cessation medications identified as effective in this Guideline.598

Issues particular to this population (e.g., mobility, medications) make 

the use of proactive telephone counseling appear particularly promising. 

Importantly, Medicare has expanded benefits for tobacco cessation counseling and prescription medications (through Medicare Part D) for tobacco 

dependence treatment.219

 Future Research

The following topics regarding older smokers require additional research:

• Effectiveness of tailored as well as general counseling interventions for 

older smokers in promoting tobacco abstinence

• Effectiveness and side effects of medications

• Effective methods to motivate older smokers to make a quit attempt

Psychiatric Disorders, Including Substance Use 

Disorders

Psychiatric disorders are more common among smokers than in the general population. For instance, as many as 30 to 60 percent of patients seeking 
Treating Tobacco Use and Dependence: 2008 Update

154

tobacco dependence treatment may have a past history of depression,599,600

and 20 percent or more may have a past history of alcohol abuse or dependence.601-603 Smoking occurs at rates well above the population average 

among abusers of alcohol and drugs (i.e., greater than 70 percent),604-607

and one study found that these individuals have increased mortality from 

tobacco-related diseases.608 These individuals may present themselves less 

frequently for tobacco dependence treatment. However, such treatments 

could be conveniently delivered within the context of chemical dependence 

or mental health clinics.609

As noted in the Specialized Assessment section in Chapter 6A, smokers 

currently experiencing a psychiatric disorder are at heightened risk for 

relapse to smoking after a cessation attempt.246,466,610-613

All smokers with psychiatric disorders, including substance use disorders, 

should be offered tobacco dependence treatment, and clinicians must 

overcome their reluctance to treat this population.614 However, the clinician may wish to offer the tobacco dependence treatment when psychiatric 

symptoms are not severe. Although patients in inpatient psychiatric units 

are able to stop smoking with few adverse effects (e.g., little increase in aggression),615-617 stopping smoking or nicotine withdrawal may exacerbate 

a patient’s comorbid condition. For instance, stopping smoking may elicit 

or exacerbate depression among patients with a prior history of affective 

disorder.325,618,619 One study suggests that alcohol treatment should precede 

tobacco dependence treatment to maximize the effect of the alcohol treatment.483 Considerable research, however, also indicates that tobacco dependence treatment does not interfere with patients’ recovery from the abuse 

of other substances.474,475,477,480-482,620 Treating tobacco dependence in individuals with psychiatric disorders is made more complex by the potential 

for multiple psychiatric diagnoses and multiple psychiatric medications. 

Stopping tobacco use may affect the pharmacokinetics of certain psychiatric medications.308,621 Therefore, clinicians should closely monitor the level 

or effects of psychiatric medications in smokers making a quit attempt.75

 Future Research

The following topics regarding psychiatric disorders, including substance 

use disorders, require additional research:
Specific Populations and Other Topics

155

•	 Relative effectiveness and reach of different tobacco dependence medications and counseling strategies in patients with psychiatric comorbidity, including depression

•	 Effectiveness and impact of tobacco dependence treatments within the

context of nontobacco chemical dependency treatments

•	 Importance and effectiveness of specialized assessment and tailored

interventions in these populations

•	 Impact of stopping tobacco use on psychiatric disorders and their

management

Racial and Ethnic Minority Populations

Some racial and ethnic minority populations in the United States—African 

Americans, American Indians and Alaska Natives, Asians and Pacific 

Islanders, Hispanics—experience higher mortality in a number of disease 

categories compared with others. For example, African Americans experience substantial excess mortality from cancer, cardiovascular disease, and 

infant death, all of which are directly affected by tobacco use.622-626 Moreover, they experience greater exposure to tobacco advertising.627-629 American Indian and Alaska Natives have some of the highest documented rates 

of infant mortality caused by SIDS,630,631 which also is affected by tobacco 

use and exposure to secondhand smoke. Therefore, the need to deliver 

effective tobacco dependence interventions to ethnic and racial minority 

smokers is critical. Unfortunately, evidence indicates that large proportions 

of some racial/ethnic groups lack adequate access to primary care providers and are more likely to have low SES.632,633 These populations may be 

less aware of Medicaid or other available benefits564,633-635 and more likely to 

harbor misconceptions about tobacco dependence treatments.636-639 Finally, 

these populations may be less likely to receive advice to stop smoking640,641

or use tobacco dependence treatment635,637,642 than are other individuals. 

This suggests that special efforts and resources should be provided to meet 

the treatment needs of these underserved populations.4,643

The differences between racial and ethnic minorities and whites in smoking prevalence, smoking patterns, pharmacokinetics of nicotine, and 

quitting behavior in the United States are well documented.587,642,644-656 In 

addition, smoking prevalence and patterns vary substantially across and 
Treating Tobacco Use and Dependence: 2008 Update

156

within minority subgroups (e.g., gender, level of acculturation, tribal communities).636,657-663 Racial and ethnic minority groups also differ from whites 

in awareness of the health effects of smoking636,664-667 and awareness of the 

benefits of proven treatments, and some racial and ethnic minority populations report a greater sense of fatalism that may affect disease prevention 

efforts.637,660 On the other hand, both tobacco dependence and desire to 

quit appear to be prevalent across varied racial and ethnic groups.642,667-671

In fact, smokers in several racial and ethnic groups attempt to quit as often 

as or more often than nonminority smokers, but use effective treatments 

less often and have lower success rates.642,672

 Future Research

The following topics regarding racial and ethnic minorities require additional research:

•	 Effectiveness of specific tobacco dependence interventions, including

medications and quitlines, in these populations (e.g., American Indian 

and Alaska Native smokers)

•	 Effectiveness of culturally adapted versus generic interventions for different racial and ethnic minority populations

•	 Identification and development of interventions to address the specific

barriers or impediments to treatment delivery, use, or success (e.g., 

SES, inadequate access to medical care, treatment misconceptions, not 

viewing tobacco use as problematic)

•	 Identification of motivators of cessation that are especially effective

with members of racial and ethnic minority populations (e.g., fear of 

illness requiring long-term care and disability)

Women

Data suggest that women are more likely to seek assistance in their quit 

attempts than are men.673 Research suggests that women benefit from the 

same interventions as do men, although the data are mixed on whether 

they benefit as much as men.156,157 Women may face different stressors and 

barriers to quitting that may be addressed in treatment. These include 

greater likelihood of depression, greater weight control concerns, hormon-
Specific Populations and Other Topics

157

al cycles, greater nonpharmacologic motives for smoking (e.g., for socialization), educational differences, and others.248 This suggests that women 

may benefit from tobacco dependence treatments that address these issues, 

although few studies have examined programs targeted at one gender. 

 Future Research

The following topics regarding gender differences require additional research: 

•	 Gender differences in the effectiveness of tobacco dependence treatments found to be effective in this Guideline, including counseling and 

the effectiveness of varenicline and combination medications

•	 Impact of gender-specific motives that may increase quit attempts and

success (e.g., quitting to improve fertility and reproductive health, 

pregnancy outcomes, physical appearance, and osteoporosis)

Other Specific Populations and Topics 

Children and Adolescents

Recommendation: Clinicians should ask pediatric and adolescent 

patients about tobacco use and provide a strong message regarding the 

importance of totally abstaining from tobacco use. (Strength of 

Evidence = C)

Recommendation: Counseling has been shown to be effective in treatment of adolescent smokers. Therefore, adolescent smokers should be 

provided with counseling interventions to aid them in quitting smoking. (Strength of Evidence = B)

Recommendation: Secondhand smoke is harmful to children. Cessation 

counseling delivered in pediatric settings has been shown to be effective in increasing abstinence among parents who smoke. Therefore, to 

protect children from secondhand smoke, clinicians should ask parents about tobacco use and offer them cessation advice and assistance. 

(Strength of Evidence = B)
Treating Tobacco Use and Dependence: 2008 Update

158

 Background

Tobacco use is a pediatric concern. In the United States, about 4,000 children and adolescents under age 18 smoke their first cigarette each day, and 

an estimated 1,200 children and adolescents become daily cigarette smokers each day.44,674 Among adults who ever smoked daily, 90 percent tried 

their first cigarette before age 21.675 It is estimated that in 2006, 3.3 million 

U.S. adolescents aged 12 to 17 were current (past month) users of tobacco 

products and 2.6 million were current cigarette smokers.43 Although use of 

cigarettes and cigars declined slightly from 2005 among this age group, the 

use of smokeless tobacco increased.43 If current patterns persist, an estimated 6.4 million youth will die prematurely from a smoking-related disease.675 Young people experiment with or begin regular use of tobacco for a 

variety of reasons, including social and parental norms, advertising, movies 

and popular media, peer influence, parental smoking, weight control, and 

curiosity.676-685 Nicotine dependence, however, is established rapidly even 

among adolescents.686-689 Because of the importance of primary prevention, clinicians should ensure that they deliver tobacco prevention and 

cessation messages to pediatric patients and their parents. Because tobacco 

use often begins during preadolescence,690 clinicians should routinely assess and intervene with this population. Intervention research remains a 

priority for this population. Current reviews of smoking prevention and 

cessation interventions for adolescents have, so far, demonstrated limited 

evidence of effectiveness.691,692 A 2007 national survey of youth tobacco cessation programs showed a lack of such programs in communities most in 

need—those in which youth smoking prevalence is increasing.693 Prevention strategies useful in more general settings can be found in the Institute 

of Medicine report Growing Up Tobacco Free694 and in the 2000 Surgeon 

General’s Report Reducing Tobacco Use6 and recently have been addressed 

by several authors.695,696

Young people vastly underestimate the addictive potential of nicotine. 

Adolescent smokers, both occasional and daily smokers, are more likely 

than nonsmokers to think they can quit at any time.697 However, only 

about 4 percent of smokers aged 12 to 19 successfully quit smoking each 

year,698,699 and the rate of failed adolescent quit attempts exceeds that of 

adult smokers.32 Adolescents are very interested in quitting; 82 percent 

of 11- to 19-year-olds who smoke are thinking about quitting,700 and 77 

percent have made a serious quit attempt in the past year.701,702 Adolescent 

quit attempts are rarely planned, and adolescents tend to choose unassisted 
Specific Populations and Other Topics

159

rather than assisted quit methods,32 even though young people who enroll 

in a tobacco cessation program are twice as likely to succeed in their quit 

attempt.703,704

 Tobacco Use Treatments in Children and Adolescents

Counseling. Seven studies met selection criteria and were included in a 

new 2008 analysis comparing counseling to usual care among adolescent 

smokers. Results of this analysis are shown in Table 7.4. As can be seen 

from this analysis, the use of counseling approximately doubles longterm abstinence rates when compared to usual care or no treatment. 

In these studies usual care may have included brief advice, self-help 

pamphlets, reading materials, or a referral. Note that although counseling 

does significantly boost abstinence rates, absolute abstinence rates were 

quite low, attesting to the need for improved counseling interventions for 

adolescents. An inspection of the included studies revealed significant 

heterogeneity among analyzed articles. Thus, the Panel decided to make a 

“B” level recommendation rather than “A” level recommendation. A recent 

Cochrane meta-analysis produced mixed findings for counseling as a 

tobacco use treatment for youth.705

Table 7.4. Meta-analysis (2008): Effectiveness of and estimated abstinence rates 

for counseling interventions with adolescent smokers (n = 7 studies)a

Adolescent 

smokers

Number of 

arms

Estimated odds ratio 

(95% C.I.)

Estimated abstinence rate 

(95% C.I.)

Usual care 7 1.0 6.7

Counseling 7 1.8 (1.1–3.0) 11.6 (7.5–17.5)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

There were too few studies to perform meta-analyses on specific counseling techniques (e.g., motivational interviewing). The adolescent intervention studies that yielded significant effects used interventions that varied 

in intensity, format, and content. One study used an intervention that had 

one in-person counseling session and one telephone call; the other two 

interventions comprised six and eight sessions of counseling delivered in 

a group format. The counseling content of these interventions involved 

efforts to enhance motivation, establish rapport, set goals, promote problemsolving and skill training, and prevent relapse.482,706,707 One recent 

meta-analysis found significant effects for studies that employed cognitive-
Treating Tobacco Use and Dependence: 2008 Update

160

behavioral strategies (self-monitoring and coping skills), social influence 

strategies (addressing social influences that serve to promote or maintain 

smoking), and motivational strategies (techniques to clarify desire for 

change and reduce ambivalence toward change).704

A series of studies comparing intensive group sessions based on social/

cognitive therapy to a 10- to 20-minute brief intervention produced promising results, at least when measured at the end of treatment, across diverse 

adolescent populations.708-716 Interventions should be developmentally appropriate across the adolescent age span (e.g., appropriate for a 12-year-old 

vs. an 18-year-old). Additionally, counseling and other interventions have 

been recommended for young adults ages 18 to 24 years old.717

Recent studies indicate that adolescent smokers are identified and counseled to quit in about 33 to 55 percent of physician visits120,718,719 and about 

20 percent of dental visits.120 Receipt of assistance in quitting was reported 

by 42 percent of adolescents and followup by only 16 percent of adolescents.719 Yet, in a survey of 5,000 adolescents (all of the 11th graders in 

the Memphis City Schools), more than 79 percent reported they would 

acknowledge their smoking if asked.718 Therefore, clinicians need to assess 

adolescent tobacco use, offer counseling, and follow up with these patients. 

Asking about tobacco use and advising adolescents to quit are the entry 

points for providing effective interventions. Clinicians may use motivational interventions such as those listed in Chapter 3B, which can be adapted 

for use with adolescents.173,706,720,721 It is important for clinicians to intervene 

with adolescents in a manner that respects confidentiality and privacy (e.g., 

interviewing adolescents without parents present). 

Counseling Provided to Parents During the Pediatric Visit. Recent research 

suggests that tobacco use interventions provided to parents in pediatric clinics or during child hospitalizations increase parents’ interest 

in stopping smoking,198,722 parents’ quit attempts198,199 and parents’ quit 

rates,172,723,724 although one study failed to find such an effect.428

Children and adolescents also benefit if parents are given information on 

secondhand smoke exposure. A review of the studies conducted by the expert Panel showed that giving parents information on the harms of secondhand smoke reduces childhood exposure to such smoke and may reduce 

parental smoking rates.198,725
Specific Populations and Other Topics

161

Questions have been raised about whether and how clinicians caring for 

children and adolescents might offer treatment for tobacco dependence 

to their parents who smoke. Would such treatment interfere with the 

doctor-patient relationship that parents might have with their physicians? 

In response to this concern, the American Medical Association adopted a 

policy statement in 2005 supporting the practice of pediatricians addressing parental smoking.726

Tobacco Use Medications. Although nicotine replacement has been shown 

to be safe in adolescents,there is little evidence that these medications and 

bupropion SR are effective in promoting long-term smoking abstinence 

among adolescent smokers.727-731 As a result, they are not recommended as 

a component of pediatric tobacco use interventions. One small pilot study 

(N = 22) found some positive initial effects for bupropion SR.730 However, 

other studies have found no difference between placebo and patch at 10 or 

12 weeks postquit727 or between placebo versus gum or patch at 6 months 

postquit.729,732 The majority of these studies also included an intensive 

counseling component (6 or more sessions).

 Future Research

The following topics regarding adolescents and children require additional 

research:

•	 Effectiveness of using the 5 A’s in pediatric clinics to treat both adolescents and parents

•	 Safety and effectiveness of medications in adolescents, including bupropion SR, NRT, varenicline, and a nicotine vaccine

•	 Effectiveness of counseling interventions designed specifically to motivate youth to stop using tobacco

•	 Effectiveness of child-focused versus family-focused or peer-focused

interventions as well as interventions accessed via the Internet, quitlines, and school-based programs

•	 Strategies for increasing the efficacy, appeal, and reach of counseling

treatments for adolescent smokers
Treating Tobacco Use and Dependence: 2008 Update

162

Light Smokers

Recommendation: Light smokers should be identified, strongly urged 

to quit, and provided counseling cessation interventions. (Strength of 

Evidence = B)

The field of tobacco dependence research has not achieved consensus regarding the definition of a light smoker. For the purposes of this Guideline, 

the Panel considered a light smoker to be anyone who smokes fewer than 

10 cigarettes per day, given that these individuals frequently are excluded 

from the RCTs that are the basis of some of the treatment recommendations. This definition includes individuals who may not smoke daily. Light 

smoking does not refer to smoking low-tar/low-nicotine cigarettes. Despite lower consumption levels, light smokers are at risk for developing 

smoking-related diseases.733,734 A large, longitudinal study in Norway (N = 

42,722) found an increase in risk of death from ischemic heart disease and 

other tobacco-related causes for both men and women who smoked one to 

four cigarettes per day.735 Similar results were found in a Finnish cohort, in 

which men who reported being “occasional smokers” demonstrated increased cardiovascular morbidity and mortality.736

Light smoking is becoming more common, perhaps due to smoking 

restrictions and increases in the price of cigarettes.734,737 A recent National 

Health Interview Survey (NHIS) survey found that among adult smokers in the United States, approximately 25.4 percent report smoking 10 or 

fewer cigarettes per day, and 11.6 percent smoke 5 or fewer cigarettes per 

day.738 Many light smokers want to quit but have difficulty doing so.734 This 

is consistent with evidence that many light smokers are dependent, even 

though they smoke relatively few cigarettes.739 Light smokers also are less 

likely to receive treatment than are heavier smokers.734,740

Light smokers should be provided counseling treatments identified as effective in this Guideline. One study found that health education was more 

effective than motivational interviewing for African-American light smokers ( ≤ 10 cigarettes per day).176

Tobacco Use Medications. Two studies examined the effectiveness of medications with light smokers. One study found that use of the nicotine lozenge significantly increased 12-month abstinence rates among light smok-
Specific Populations and Other Topics

163

ers ( ≤ 15 cigarettes per day) compared to placebo.741 Another study found 

no difference in effectiveness of 2-mg gum versus placebo.176

 Future Research

The following topic regarding light smokers requires additional research:

•	 Effectiveness of specific counseling and medication interventions with

lighter smokers

Noncigarette Tobacco Users

Recommendation: Smokeless tobacco users should be identified, 

strongly urged to quit, and provided counseling cessation interventions. 

(Strength of Evidence = A)

Recommendation: Clinicians delivering dental health services should 

provide brief counseling interventions to all smokeless tobacco users. 

(Strength of Evidence = A)

Recommendation: Users of cigars, pipes, and other noncigarette forms 

of smoking tobacco should be identified, strongly urged to quit, and 

offered the same counseling interventions recommended for cigarette 

smokers. (Strength of Evidence = C)

Like cigarette smoking, the use of smokeless tobacco, such as chewing 

tobacco, snuff, or moist snuff, produces addiction to nicotine and has serious health consequences.742-744 Smokeless tobacco use was reported among 

4 percent of adult men, but less than 1 percent of women in 2005.591,745

Health risks from these products include abrasion of teeth, gingival recession, periodontal bone loss, leukoplakia, and oral and pancreatic cancer.745,746 Thus, the use of smokeless tobacco is not a safe alternative to 

smoking,747 nor is there evidence to suggest that it is effective in helping 

smokers quit.

Evidence shows that counseling treatments are effective in treating smokeless tobacco users.748-750 Therefore, clinicians should offer quitting advice 

and assistance to their patients who use tobacco, regardless of the formulation of the tobacco product. Some information may be particularly relevant 
Treating Tobacco Use and Dependence: 2008 Update

164

in the treatment of smokeless tobacco use. For instance, a large majority 

of moist snuff users have identifiable oral lesions, and emphasizing this information during an oral exam may be useful in motivating a quit attempt. 

A close review of the literature showed that dental health clinicians (e.g., 

dental hygienists) delivering brief advice to quit using smokeless tobacco, 

in the context of oral hygiene feedback, can increase abstinence rates.250,751

Cigar smokers are at increased risk for coronary heart disease; COPD; 

periodontitis; and oral, esophageal, laryngeal, lung, and other cancers; 

with evidence of dose-response effects.752-756 The prevalence of cigar smoking was 5 percent for men and less than 1 percent for women.590 Although 

cigarette sales have declined over the last decade, cigar sales have increased 

in the United States, increasing 15.3 percent in 2005,757 and sales of “little 

cigars” were at an all-time high in 2006.758 Cigar smokers are known to discount the health effects of cigar smoking, believing it to be less detrimental 

than cigarettes.752,759

Clinicians should be aware of and address the use of other noncigarette 

tobacco products, including pipes, water pipes (also known as hookahs and 

narghile), cigarillos, loose tobacco, bidis, and betel quid. The use of cigars, 

pipes, and bidis is associated with cancers of the lung, stomach, oral cavity, 

larynx, and esophagus.760 Further, the evidence is mixed as to whether or 

not individuals who use noncigarette tobacco products, either alone or in 

addition to cigarettes, find it more or less difficult, in comparison to cigarette smokers, to become abstinent from tobacco.761,762

Tobacco Use Medications. Current evidence is insufficient to suggest that 

the use of tobacco cessation medications increases long-term abstinence 

among users of smokeless tobacco. Studies conducted to date with various medications have not shown that they increase abstinence rates in this 

population.750,751,763,764

 Future Research

The following topics regarding noncigarette tobacco products require additional research:

•	 Effectiveness of advice and counseling treatments in promoting abstinence among users of noncigarette tobacco products, especially among 

users of pipes, cigars, and hookahs
Specific Populations and Other Topics

165

•	 Effectiveness of medications to promote abstinence among users of

noncigarette tobacco products, including users of smokeless tobacco, 

pipes, cigars, and hookahs

•	 Effectiveness of combined medications and counseling and behavioral

therapies with users of noncigarette tobacco products

•	 Effectiveness of medication and counseling interventions with individuals who both smoke cigarettes and use noncigarette tobacco products 

(“dual users”)

Pregnant Smokers

Recommendation: Because of the serious risks of smoking to the pregnant smoker and the fetus, whenever possible pregnant smokers should 

be offered person-to-person psychosocial interventions that exceed 

minimal advice to quit. (Strength of Evidence = A)

Recommendation: Although abstinence early in pregnancy will produce the greatest benefits to the fetus and expectant mother, quitting at 

any point in pregnancy can yield benefits. Therefore, clinicians should 

offer effective tobacco dependence interventions to pregnant smokers 

at the first prenatal visit as well as throughout the course of pregnancy. 

(Strength of Evidence = B)

Psychosocial Interventions. The selection criteria for the pregnancy metaanalysis were adjusted to be appropriate for this unique population. Abstinence data were included only if they were biochemically confirmed, 

due to reports of deception regarding smoking status among pregnant 

women.765-769 Two different followup time periods were analyzed: prebirth 

abstinence (> 24 weeks gestation) and greater than 5 months postpartum abstinence. For the meta-analysis, either minimal interventions (< 3 minutes) 

or interventions labeled as “usual care” constituted the reference condition. 

Eight studies met the criteria and were included in the analysis comparing 

person-to-person psychosocial smoking cessation interventions with usual 

care in pregnant women. A “usual care” intervention with pregnant smokers typically consists of a recommendation to stop smoking, often supplemented by provision of self-help material or referral to a stop-smoking 

program or brief counseling. Person-to-person psychosocial interventions 

typically involved these treatment components as well as more intensive 
Treating Tobacco Use and Dependence: 2008 Update

166

counseling than minimal advice. One study included 12 telephone counseling sessions after an initial in-person counseling session, and the remainder of the studies had at least two in-person counseling sessions. One study 

used a group intervention, and all of the other studies provided individual 

counseling. Six of the studies provided counseling only during pregnancy, 

one provided counseling in the hospital, and one provided counseling 

postdelivery. As Table 7.5 shows, psychosocial interventions are significantly more effective than usual care in getting pregnant women to quit 

while they are pregnant. These findings are consistent with other independent reviews.770 A meta-analysis also was conducted to examine the effects 

of psychosocial interventions on postpartum abstinence. The odds ratio for 

psychosocial intervention was consistent with a positive effect of counseling on postpartum abstinence; however, the results were not statistically 

significant (OR = 1.6, 95 percent C.I. = 0.7–3.5). Studies using telephone 

counseling as the only format that compared biochemically verified outcomes to a minimal intervention suggest a possible differential effect on 

light versus heavy smokers and underscore the need for further research 

about this format.771,772

Table 7.5. Meta-analysis (2008): Effectiveness of and estimated preparturition 

abstinence rates for psychosocial interventions with pregnant smokers 

(n = 8 studies)a

Pregnant 

smokers

Number of 

arms

Estimated odds ratio 

(95% C.I.)

Estimated abstinence rate 

(95% C.I.)

Usual care 8 1.0 7.6

Psychosocial 

intervention 

(abstinence 

preparturition)

9 1.8 (1.4–2.3) 13.3 (9.0–19.4)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Components of some person-to-person psychosocial interventions are 

listed in Table 7.6. These interventions were selected from articles included 

in the Table 7.5 meta-analysis and should guide clinicians when treating 

pregnant smokers. 
Specific Populations and Other Topics

167

Table 7.6. Examples of effective psychosocial interventions with pregnant patients

Physician advice regarding smoking-related risks (2–3 minutes); videotape with information on risks, barriers, and tips for quitting; midwife counseling in one 10-minute 

session; self-help manual; and followup letters.773

Pregnancy-specific self-help materials (Pregnant Woman’s Self-Help Guide To Quit 

Smoking) and one 10-minute counseling session with a health educator.774

Counselor provided one 90-minute counseling session plus bimonthly telephone followup calls during pregnancy and monthly telephone calls after delivery.775

Smoking in pregnancy imparts risks to both the woman and the fetus. 

Cigarette smoking by pregnant women has been shown to cause adverse 

fetal outcomes, including stillbirths, spontaneous abortions, decreased 

fetal growth, premature births, low birth-weight, placental abruption, and 

sudden infant death syndrome (SIDS); and has been linked to cognitive, 

emotional, and behavioral problems in children.776,777 Many women are 

motivated to quit during pregnancy, and health care professionals can take 

advantage of this motivation by reinforcing the knowledge that cessation 

will reduce health risks to the fetus and that there are postpartum benefits 

for both the mother and child.778-780

The first step in intervention is assessment of tobacco use status. This is 

especially important in a population in which a stronger stigma against 

smoking increases the potential for deception.781,782 Research has shown 

that the use of multiple choice questions (see Table 7.7), as opposed to a 

simple yes/no question, can increase disclosure among pregnant women by 

as much as 40 percent.783,784

Table 7.7. Clinical practice suggestions for assisting a pregnant patient in stopping 

smoking

Clinical practice Rationale

Assess pregnant woman’s 

tobacco use status using a 

multiple-choice question to 

improve disclosure.

Many pregnant women deny smoking, and the 

multiple-choice question format improves disclosure. 

For example:

Which of the following statements best describes your 

cigarette smoking?

• I smoke regularly now; about the same as before finding out I was pregnant.

• I smoke regularly now, but I’ve cut down since I found 

out I was pregnant.

• I smoke every once in a while.
Treating Tobacco Use and Dependence: 2008 Update

168

Clinical practice Rationale

Assess pregnant woman’s 

tobacco use status using a 

multiple-choice question to 

improve disclosure.

• I have quit smoking since finding out I was pregnant.

• I wasn’t smoking around the time I found out I was 

pregnant, and I don’t currently smoke cigarettes.

Congratulate those smokers 

who have quit on their own.

To encourage continued abstinence.

Motivate quit attempts by 

providing educational messages about the impact of 

smoking on both maternal 

and fetal health.

These are associated with higher quit rates.

Give clear, strong advice to 

quit as soon as possible.

Quitting early in pregnancy provides the greatest benefit to the fetus.

Use problemsolving 

counseling methods and 

provide social support and 

pregnancy-specific self-help 

materials.

Reinforces pregnancy-specific benefits and increases 

cessation rates.

Arrange for followup assessments throughout 

pregnancy, including further 

encouragement of cessation.

The woman and her fetus will benefit even when quitting occurs late in pregnancy.

In the early postpartum 

period, assess for relapse 

and be prepared to continue 

or reapply tobacco cessation 

interventions, recognizing 

that patients may minimize 

or deny smoking.

Postpartum relapse rates are high, even if a woman 

maintains abstinence throughout pregnancy. 

Quitting smoking prior to conception or early in the pregnancy is most 

beneficial, but health benefits result from abstinence at any time.742,785-787

It is estimated that 20 percent or more of low birth-weight births could 

be prevented by eliminating smoking during pregnancy.592,788 Therefore, 

a pregnant smoker should receive encouragement and assistance in quitting throughout her pregnancy. Women attending preconception or other 

medical visits also should be offered tobacco use interventions, as smoking may decrease fertility789,790 and some adverse effects occur early in the 

pregnancy.788 In addition, treating tobacco dependence prior to conception 

Table 7.7. Clinical practice suggestions for assisting a pregnant patient in stopping 

smoking (continued)
Specific Populations and Other Topics

169

offers more options to the clinician, including medication options, as fetal 

health concerns are not present. 

Even women who have maintained total abstinence from tobacco for 6 

or more months during pregnancy have a high rate of relapse in the postpartum period.787,791,792 Postpartum relapse may be decreased by continued emphasis on the relationship between maternal smoking and poor 

health outcomes in infants and children (e.g., SIDS, respiratory infections, 

asthma, and middle ear disease).793-798 One pilot study found that a relapse 

prevention intervention was effective;799 however, two reviews of relapse 

prevention trials (both pre- and postdelivery) found no significant reduction in relapse.185,770 There is a great need for research on the prevention 

of postpartum relapse. Table 7.7 outlines clinical factors to address when 

counseling pregnant women about smoking. 

Meta-analytic results support the effectiveness of self-help materials compared to either basic information sheets or no intervention in assisting 

women to quit during pregnancy (see Table 7.8). Pamphlets and quitting 

guides were used as the self-help intervention in both studies analyzed. 

Other studies document favorable outcomes when self-help materials, with 

or without brief discussion/counseling, are added to standard advice to 

quit smoking.774,800

Table 7.8. Meta-analysis (2008): Effectiveness of and estimated preparturition 

abstinence rates for self-help interventions with pregnant smokers (n = 2 studies)a

Pregnant smokers Number 

of arms

Estimated odds 

ratio (95% C.I.)

Estimated abstinence rate 

(95% C.I.)

Usual care 2 1.0 8.6

Self-help materials 

(preparturition)

2 1.9 (1.2–2.9) 15.0 (10.1–21.6)

a

 Go to www.surgeongeneral.gov/tobacco/gdlnrefs.htm for the articles used in this meta-analysis.

Tobacco use medication and pregnant smokers—Effectiveness. The data on 

the effectiveness of nicotine replacement therapy with pregnant smokers 

include three randomized, controlled nicotine patch studies. One study 

randomly assigned 250 pregnant women who still were smoking after the 

first trimester to either a 15-mg, 16-hour active patch for 8 weeks and a 

10-mg, 16-hour patch for 3 additional weeks or to a placebo. No significant 
Treating Tobacco Use and Dependence: 2008 Update

170

differences were seen in smoking abstinence rates, number of cigarettes 

smoked, birthweight, or number of preterm deliveries.801 A similar study 

of the nicotine patch with 30 pregnant women who still were smoking 

15 or more cigarettes a day after the first trimester found moderate but 

nonsignificant differences in abstinence rates (23% in the active patch and 

counseling condition vs. 0% in the placebo patch and counseling condition).802 A recent study803 randomized 181 pregnant women to cognitive 

behavioral therapy (CBT) and NRT or CBT alone. Women in the CBT plus 

NRT group were significantly more likely to be abstinent at 7 weeks postrandomization (29% vs. 10%) and at 38 weeks gestation (22% vs. 7%). This 

study was stopped prior to completion (see safety section below). Based on 

these data, the Panel did not make a recommendation regarding medication use during pregnancy. 

Tobacco use medication and pregnant smokers—Safety. Cigarette smoking during pregnancy is the greatest modifiable risk factor for pregnancyrelated morbidity and mortality in the United States.804 Adverse effects of 

smoking during and after pregnancy include increased risks of spontaneous abortion,805 premature labor and delivery,806 placental abruption,807 fetal 

growth retardation,808-810 SIDS,811,812 and many health risks for the woman 

and her child.794,813

Cigarette smoke contains thousands of chemicals, many of which may 

contribute to reproductive toxicity. Of particular concern are carbon monoxide, nicotine, and oxidizing chemicals.814 High levels of carbon monoxide exert neuroteratogenic effects.815,816 Oxidizing chemicals are likely to 

contribute to an increased risk of thrombotic complications and, by reducing nitric oxide availability, contribute to placental vasoconstriction and 

premature labor.817,818

Nicotine may contribute to adverse effects of cigarette smoking during 

pregnancy and result in injury to the fetus.819-821 Nicotine has been postulated to cause uteroplacental insufficiency via vasoconstriction, to produce 

fetal neurotoxicity resulting in delayed or impaired brain development, to 

inhibit the maturation of pulmonary cells and to increase the risk of SIDS. 

These concerns are based primarily on animal studies. Relatively little human research with pure nicotine has been done in pregnant smokers.

Several studies of brief exposure to nicotine patches or nicotine gum have 

demonstrated small hemodynamic effects in the mother and fetus, gener-
Specific Populations and Other Topics

171

ally less than those seen with cigarette smoking.822 The three clinical trials 

of NRT in pregnant women have yielded information relative to safety. 

The Wisborg trial of 250 women randomized to nicotine patch (15 mg) or 

placebo for 11 weeks found no evidence of serious adverse effects of nicotine.801 To the contrary, birth weight was significantly higher in the NRT 

group, possibly due to reduced cigarette smoking in the NRT group. The 

Kapur study included 30 women randomized to nicotine patches (15 mg) 

or placebo, and reported no serious adverse effects of NRT.802 One placebotreated woman experienced extreme nicotine withdrawal, associated with 

increased fetal movements, prompting discontinuation of the trial. The 

Pollack study included 181 women, 122 randomized to CBT plus NRT, and 

59 to CBT alone.803 The NRT group could select nicotine patches, gum, or 

lozenge, or no NRT. More than half the women selected nicotine patches, 

the dose of which was adjusted according to the number of cigarettes 

smoked per day on study entry. As described in the “effectiveness” section 

above, women treated with NRT had significantly higher quit rates during 

pregnancy than did women receiving CBT alone. However, the study was 

terminated early by the Data Safety Monitoring Board (DSMB) due to a 

higher incidence of adverse events. Serious adverse events occurred in 30 

percent of the NRT group compared to 17 percent of the CBT-alone group. 

The most frequent cause of serious adverse events was preterm labor. There 

was evidence that this difference in preterm labor was due to a difference 

between groups in history of preterm labor that predated study entry. The 

DSMB indicated that the study had to be terminated due to a priori stopping rules; however, they did not believe that the serious adverse events 

were related to NRT use. The authors concluded that this study cannot 

support or negate published literature about the harm of NRT during pregnancy. 

Morales-Suarez-Varela et al. reported data from a retrospective cohort 

study suggesting that the use of NRT in women who quit smoking but 

who used nicotine substitutes during the first 12 weeks of pregnancy was 

associated with a small but significant increase in congenital malformations compared to mothers who smoked during the first trimester.823 This 

study suffers from multiple, substantial methodological problems, however, 

making its findings difficult to interpret. Also, the number of malformation 

cases in the NRT group was quite small, and the relative prevalence rate 

ratios for malformations in cases compared to controls were of borderline 

significance. Further, concerns exist about possible undetected spontaneous abortion among continuing smokers. In addition, most women who 
Treating Tobacco Use and Dependence: 2008 Update

172

use NRT do so in the second or third trimester, and no adverse event data 

were reported in these women. 

Safety is not categorical. A designation of “safe” reflects a conclusion that 

a drug’s benefits outweigh its risks. Nicotine most likely does have adverse 

effects on the fetus during pregnancy. Although the use of NRT exposes 

pregnant women to nicotine, smoking exposes them to nicotine plus numerous other chemicals that are injurious to the woman and fetus. These 

concerns must be considered in the context of inconclusive evidence that 

cessation medications boost abstinence rates in pregnant smokers.

 Future Research

The following topics regarding smoking and pregnancy require additional 

research:

•	 Relapse prevention with pregnant women and women who have recently given birth

•	 Effectiveness of psychosocial treatment provided via nonface-to-face

modalities, such as quitlines or Web-based programs

•	The safety and effectiveness of tobacco dependence medications (bupropion SR, NRTs, and varenicline) during pregnancy for the woman 

and the fetus, including: the relative risks and benefits of medication 

use as a function of dependence, and the appropriate formulation and 

timing of medication use

•	 Safety and effectiveness of tobacco dependence medications, especially

varenicline and bupropion SR as well as various forms of NRT, to the 

woman and child during nursing

•	 Effectiveness of economic incentives to promote quitting and sustained

abstinence

•	 Effects of smoking during fertility treatment and the effects and effectiveness of cessation interventions on the infertile population, both 

men and women
Specific Populations and Other Topics

173

•	 Effects of reporting smoking status and the provision of cessation

interventions as part of the national database for assisted reproductive 

technology treatments (the Center for Disease Control and Prevention’s Assisted Reproductive Technology [ART] database, www.cdc.

gov/art) 

•	 Effectiveness of relapse prevention programs for spontaneous “selfquitters amongst pregnant women”

•	 Effectiveness of different types of counseling, behavioral therapies,

and motivational interventions (e.g., physiological feedback of adverse impacts, quitting benefits) for pregnant women in general and in 

high-prevalence populations (e.g., American Indian and Alaska Native 

women, especially)

•	 Strategies for linking preconception, pregnancy, and postpartum (including pediatric) interventions

Weight Gain After Stopping Smoking 

Recommendation: For smokers who are greatly concerned about weight 

gain, it may be most appropriate to prescribe or recommend bupropion 

SR or NRT (in particular, nicotine gum and nicotine lozenge), which 

have been shown to delay weight gain after quitting. (Strength of Evidence = B)

The majority of smokers who quit smoking gain weight. Most will gain 

fewer than 10 pounds, but there is a broad range of weight gain, with as 

many as 10 percent of quitters gaining as much as 30 pounds.824-827 However, weight gain that follows stopping smoking is a modest health threat 

compared with the risks of continued smoking.824

Women tend to gain slightly more weight than men do.828 For both sexes, 

African Americans, people under age 55, and heavy smokers (those smoking more than 25 cigarettes per day) are at elevated risk for major weight 

gain.826,829-831

For some smokers, especially women, concerns about weight or fears about 

weight gain are motivators to start smoking or continue smoking.832-836
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174

Adolescents, even as young as middle-school age, who are concerned about 

their weight initiate smoking more often than do other adolescents.683,837-838

Concern about weight varies substantially by ethnicity. For example, adolescent African-American females are much less likely to report that they 

smoke to control weight than are white European Americans.683,839 This is 

an important area for further study, as little tobacco research focuses on 

women in racial/ethnic minority groups.683

There is no convincing evidence that counseling interventions specifically 

designed to mitigate weight gain during attempts to stop smoking result in 

reduced weight gain.165,499,840 It also is unclear that such interventions affect 

cessation success; specifically, these interventions do not appear to adversely affect cessation.499,840-842

Nicotine replacement—in particular, 4-mg nicotine gum and 4-mg nicotine lozenge—appears to be effective in delaying postcessation weight gain. 

Moreover, there appears to be a dose-response relation between gum use 

and weight suppression (i.e., the greater the gum use, the less weight gain 

occurs). Bupropion SR also appears to be effective in delaying postcessation weight gain.484,843-845 Once either nicotine gum or bupropion SR therapy is stopped, however, the quitting smoker, on average, gains an amount 

of weight that is about the same as if she or he had not used these medications.843,846-848

Postcessation weight gain appears to be caused both by increased intake 

(e.g., eating, including high-caloric foods, and alcohol consumption) and 

by decreased metabolism. The involvement of metabolic mechanisms 

suggests that even if smokers do not increase their caloric intake upon 

quitting, they will, on average, gain some weight.849-852 Once an individual 

relapses and begins smoking at precessation levels, he or she usually will 

lose some or all of the weight gained during the quit attempt.

The research evidence reviewed above shows why concerns about weight 

gain can be barriers to smoking abstinence. Many smokers (especially 

women) are concerned about their weight and fear that quitting will produce weight gain. Many also believe that they can do little to prevent postcessation weight gain except return to smoking. These beliefs are difficult 

to address clinically because smoking does appear to affect weight.
Specific Populations and Other Topics

175

 Recommendations to Clinicians When Addressing

 Weight Gain

How should the clinician deal with concerns about weight gain? First, 

the clinician should neither deny the likelihood of weight gain nor minimize its significance to the patient. Rather, the clinician should inform 

the patient about the likelihood of weight gain and prepare the patient for 

its occurrence. The clinician also should counter exaggerated fears about 

weight gain given the relatively moderate weight gain that typically occurs. 

Certain types of information may help prepare the patient for postcessation 

weight gain (see Table 7.9). Clinicians also should inform the patient that 

smoking presents a much greater health risk than the negligible health risk 

involved in the modest weight gain associated with smoking abstinence. 

Second, during the quit attempt, the clinician should offer to help the 

patient address weight gain (either personally or via referral) once the 

patient has successfully quit smoking. The patient should be encouraged 

to maintain or adopt a healthy lifestyle, including engaging in moderate 

exercise, eating plenty of fruits and vegetables, and limiting alcohol consumption.502,853

 Exercise

Available research does not show that interventions to increase exercise 

reliably boost smoking abstinence rates.842,854 One recent study, however, 

showed that an exercise program occurring in three 45-minute sessions per 

week increases long-term smoking abstinence in women and delays weight 

gain when it is combined with a cognitive-behavioral smoking cessation 

program.853 As was the case for weight loss interventions, there is no evidence that exercise interventions undermine success in stopping smoking. 

Some evidence suggests that weight gain is reduced if smoking abstinence 

is accompanied by a moderate increase in physical activity.855 Vigorous 

exercise programs should not be implemented without consulting a physician. Although it may be difficult to get smokers to adhere to a vigorous 

exercise program, smokers should be encouraged to engage in moderate 

exercise and physical activity as part of a healthy lifestyle.856
Treating Tobacco Use and Dependence: 2008 Update

176

Table 7.9. Clinician statements to help a patient prepare for and cope with postcessation weight gain

Clinician statements

The great majority of smokers gain weight once they quit smoking. However, even 

without special attempts at dieting or exercise, weight gain is usually 10 lbs. or less.

Some medications, including bupropion SR and nicotine replacement medicines, may 

delay weight gain.

There is evidence that smokers often gain weight once they quit smoking, even if they 

do not eat more. However, there are medications that will help you quit smoking and 

limit or delay weight gain. I can recommend one for you.

The amount of weight you will likely gain from quitting will be a minor health risk compared with the risks of continued smoking.

I know that you don’t want to gain a lot of weight. However, let’s focus on strategies to 

get you healthy rather than on weight. Think about eating plenty of fruits and vegetables, getting regular exercise, getting enough sleep, and avoiding high-calorie foods 

and beverages. Right now, this is probably the best thing you can do for both your 

weight and your health.

Although you may gain some weight after quitting smoking, compare the importance 

of this with the added years of healthy living you will gain, your better appearance (less 

wrinkled skin, whiter teeth, fresher breath), and good feelings about quitting. 

 Future Research

The following topics regarding weight gain during tobacco dependence 

treatment require additional research:

•	 Effectiveness of weight control measures during quit attempts and their

effect on tobacco abstinence and weight, including issues of timing of 

weight control interventions

•	 Effectiveness of medications to control weight gain during quit attempts

•	 Effectiveness of the use of exercise to control weight gain during a quit

attempt, including the optimal “dose” of exercise to minimize weight 

gain and not jeopardize cessation outcome

•	 Impact of weight gain concerns on specific populations, including adolescents who smoke and ethnic/minority women 

•	 Strategies to increase adherence to exercise protocols as part of cessation interventions that include efforts to decrease weight gain
177

Glossary

Abstinence percentage. The percentage of smokers who achieve long-term 

abstinence from smoking. The most frequently used abstinence measure 

for this Guideline was the percentage of smokers in a group or treatment 

condition who were abstinent at a followup point that occurred at least 5 

months after treatment.

Acupuncture. A treatment involving the placement of needles in specific 

areas of the body with the intent to promote abstinence from tobacco use. 

Acupuncture also can be accomplished using electrostimulation or laser.

Addiction. Compulsive drug use, with loss of control, the development of 

dependence, continued use despite negative consequences, and specific 

withdrawal symptoms when the drug is removed.

All-comers. Individuals included in a tobacco treatment study regardless 

of whether they sought to participate. For example, if treatment was delivered to all smokers visiting a primary care clinic, the treatment population would be coded as “all-comers.” Presumably, individuals who seek to 

participate in tobacco treatment studies (“want-to-quit” smokers) likely are 

more motivated to quit, and studies limited to these individuals may produce higher quit rates. All-comers can be contrasted with “want-to-quit” or 

self-selected populations.

Agonist. A drug action that generally mimics or enhances the effect of another drug at a neural receptor site. Nicotine is a cholinergic agonist.

Antagonist. A drug action that generally blocks or neutralizes the effect of 

another drug at a neural receptor site. Naltrexone and mecamylamine are 

examples of antagonists.

Anxiolytic. A medication used to reduce anxiety symptoms.

Assessment. All tobacco cessation interventions begin with identifying 

tobacco users and performing an assessment. The assessment is used to 

identify the most beneficial intervention for each smoker. Assessments may 

be specialized and may be ongoing throughout a smoking cessation program or occur at followups.
Treating Tobacco Use and Dependence: 2008 Update

178

Aversive smoking. Several types of therapeutic techniques that involve 

smoking in an unpleasant or concentrated manner. These techniques pair 

smoking with negative associations or responses. Notable examples include 

rapid smoking, rapid puffing, focused smoking, and satiation smoking.

Behavioral therapy. A psychotherapeutic approach aimed at identifying 

and modifying the behaviors associated with human problems.

Benzodiazepine. Medication used as an anxiolytic. Benzodiazepines do not 

have an FDA indication for treating tobacco use and dependence.

Bidis. Small, thin, hand-rolled cigarettes, often consisting of flavored tobacco wrapped in tendu or temburni leaves. Bidis have a higher concentration 

of nicotine, tar, and carbon monoxide than conventional cigarettes sold in 

the United States. They are imported to the United States from India and 

other Southeast Asian countries. 

Biochemical confirmation. The use of biological samples (expired air, blood, 

saliva, or urine) to measure tobacco-related compounds such as thiocyanate, cotinine, nicotine, and carboxyhemoglobin to verify users’ reports of 

abstinence. 

Bupropion SR (bupropion sustained-release). A non-nicotine aid for smoking cessation, originally developed and marketed as an antidepressant. It is 

chemically unrelated to tricyclics, tetracyclics, selective serotonin re-uptake 

inhibitors, or other known antidepressant medications. Its mechanism of 

action is presumed to be mediated through its capacity to block the reuptake of dopamine and norepinephrine centrally.

Buspirone. A nonbenzodiazepine drug with anxiolytic properties. Buspirone does not have an FDA indication for treating tobacco use and 

dependence.

Coordinated intervention. Tobacco dependence treatment strategy that 

involves the clinician, health care administrator, insurer, and purchaser 

to ensure the provision of tobacco dependence treatment as an integral 

element of health care delivery.
Glossary

179

Chronic disease model. Recognizes the long-term nature of tobacco dependence, with an expectation that patients may have periods of relapse 

and remission. The chronic disease model emphasizes the importance of 

continued patient education, counseling, and advice over time.

Cigarette fading/smoking reduction prequit. An intervention strategy designed to reduce the number of cigarettes smoked or nicotine intake prior 

to a patient’s quit date. This may be accomplished through advice to cut 

down or to systematically restrict access to cigarettes. These interventions 

use computers and/or strategies to accomplish prequitting reductions in 

cigarette consumption or nicotine intake. 

Clinician. A professional directly providing health care services.

Clinic screening system. The strategies used in clinics and medical practices 

for the delivery of clinical services. Clinic screening system interventions 

involve changes in protocols designed to enhance the identification of and 

intervention with patients who smoke. Examples include affixing tobacco 

use status stickers to patients’ charts, expanding the capture of vital signs 

to include tobacco use, incorporating tobacco use status items into patient 

questionnaires, and including prompts for tobacco use monitoring in electronic medical records.

Clonidine. An alpha-2-adrenergic agonist typically used as an antihypertensive medication, but also documented in this Guideline as an effective 

medication for smoking cessation. 

Cochrane Review. A service of the Cochrane Collaboration, an international nonprofit and independent organization (www.cochrane.org/index.htm) 

that regularly publishes evidence-based reviews about health care interventions.

Cognitive behavioral therapy (CBT). A psychotherapeutic approach aimed at 

identifying and modifying faulty or distorted negative thinking styles and 

the maladaptive behaviors associated with those thinking styles.

Combination medications. Treatment that combines two or more nicotinecontaining medications or a nicotine-containing medication with another 

tobacco treatment medication such as bupropion SR.
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Community-level interventions. Interventions for the primary prevention 

or treatment of tobacco use that usually are not implemented in primary 

care practice settings. These interventions most often are implemented 

through mass media campaigns.

Comorbidity. Coexistence of tobacco use with other medical diseases/

illnesses, including mental illnesses.

Confidence intervals. Estimated range of values, which is likely to include 

an unknown population parameter. The estimated range is calculated from 

a given set of sample data.

Contingency contracting/instrumental contingencies. Interventions that incorporate the use of tangible rewards for cigarette abstinence and/or costs 

for smoking. For the purposes of analysis, simple agreements about a quit 

date, or other agreements between treatment providers and patients without specifiable consequences, as well as deposits refunded based on study 

attendance and/or other incentives that were not contingent on smoking 

abstinence or relapse were not considered examples of contingency contracting.

Continuous abstinence. A measure of tobacco abstinence based on whether 

subjects are continuously abstinent from smoking/tobacco use from their 

quit day to a designated outcome point (e.g., end of treatment, 6 months 

after the quit day).

Cost effectiveness. Quantified analysis of tobacco dependence program 

costs relative to tobacco use related costs. 

Diazepam. A benzodiazepine medication intended to reduce anxiety.

Discrepancy. A strategy used in motivational interviewing to highlight how 

a patient’s expressed priorities, values, and goals may conflict with the use 

of tobacco.

Efficacy and effectiveness. Efficacy is the outcome achieved from a treatment provided under near-ideal circumstances of control (typically, in a 

research study). Efficacy studies involve recruitment of motivated participants, random assignment, intensive assessment, and methods designed to 

keep participants in treatment. Effectiveness is the outcome achieved from 

a treatment provided in a “real-world setting” (in a clinic or community 
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181

setting). Such studies typically involve participants who do not seek out the 

study or treatment, and the treatment is delivered in a manner consistent 

with its likely use in real-world settings. This 2008 clinical update uses the 

term “effectiveness” exclusively, recognizing that the majority of the studies 

summarized here reflect efficacy research that requires random assignment 

and a high degree of experimental control. This was done for purposes of 

clarity for its intended clinical audience. 

Environmental tobacco smoke (ETS). Also known as “secondhand smoke” 

(SHS). The smoke inhaled by an individual not actively engaged in smoking, but who is exposed to smoke from the lit end of a cigarette and the 

smoke exhaled by the smoker.

Exercise/fitness component. Refers to an intervention that contains a 

component related to exercise/fitness. The intensity of interventions falling 

within this category varies from the mere provision of information/advice 

about exercise/fitness to exercise classes.

Extratreatment social support component. Interventions or elements of 

an intervention in which patients are provided with tools or assistance in 

obtaining social support outside the treatment environment. This category 

is distinct from intratreatment social support, in which social support is 

delivered directly by treatment staff.

Fax-to-quit. Patient referral in which the patient and health care provider 

fill out a form with pertinent patient information, which is faxed to a quitline for followup.

Food and Drug Administration (FDA). Federal regulatory agency that has 

control over the safety and release of drugs marketed in the United States.

First-line medications. First-line medications have been found to be safe 

and effective for tobacco dependence treatment and have been approved by 

the FDA for this use. First-line medications have an established empirical 

record of efficacy and should be considered first as part of tobacco dependence treatment, except in cases of contraindications.

Fluoxetine. A selective serotonin re-uptake inhibitor used as a treatment 

for depression. Fluoxetine does not have an FDA indication for treating

tobacco use and dependence.
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Formats. Refers to tobacco dependence intervention delivery strategies that 

include self-help, proactive telephone counseling, computerized or e-health 

services, individual counseling, and group counseling.

Healthcare Effectiveness Data and Information Set (HEDIS). Serves as a “report card” for providing information on quality, utilization, enrollee access 

and satisfaction, and finances for managed care organizations and other 

health care delivery entities.

Higher intensity counseling. Refers to interventions that involve extended 

contact between clinicians and patients. It is coded based on the length of 

contact between clinicians and patients (greater than 10 minutes). If that 

information is unavailable, it is coded based on the content of the contact 

between clinicians and patients.

Hookah. A smoking pipe designed with a long tube passing through an urn 

of water that cools the smoke as it is drawn through. Also called “waterpipe,” “hubble-bubble,” “narghile,” “shisha.”

Hotline/helpline. A reactive telephone line dedicated to over-the-phone 

smoking intervention. Hotline/helpline treatment occurs when a hotline/

helpline number is provided to a patient, or a referral to a hotline/helpline is made. The key distinction between a hotline/helpline and proactive 

telephone counseling is that, in the former, the patient must initiate each 

clinical contact.

Hypnosis. A treatment by which a clinician induces an altered attention 

state and heightened suggestibility in a tobacco user for the purpose of promoting abstinence from tobacco use. Also referred to as hypnotherapy.

Individualized interventions. Refers to tailoring an intervention to fit the 

needs of a particular smoker. For example, relapse prevention can be individualized based on information obtained about problems the patient has 

encountered in maintaining abstinence. See also Tailored Interventions.

Intent-to-treat. Treatment outcome analyses that determine abstinence

percentages based on all subjects randomized to treatment conditions, 

rather than on just those subjects who completed the intervention or those 

who could be contacted at followup.
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Intensive interventions. Comprehensive treatments that may occur over 

multiple visits for long periods of time and may be provided by more than 

one clinician.

Internet (Web-based) interventions. Interventions delivered through the 

use of a computer. The smoker may navigate within a specific Web site to 

access general treatment and treatment information, or the smoker may 

interact with a program that delivers a tailored intervention.

Intervention. An action or program that aims to bring about identifiable 

outcomes. In tobacco dependence treatment, the intervention generally 

is clinical in nature and may consist of counseling and the use of medications. Also referred to as “treatment.”

Intratreatment social support. Refers to an intervention component that 

is intended to provide encouragement, a sense of concern, and empathic 

listening as part of the treatment.

Light smoker. The field of tobacco dependence research has not achieved 

consensus regarding the definition of a light smoker. For this publication, it 

refers to anyone who smokes between 1 and 10 cigarettes per day.

Literature review. A critical analysis of the research conducted on a particular topic or question in the field of science.

Logistic regression. Statistical technique to determine the statistical association or relation between/among two or more variables, in which the 

dependent variable is dichotomous (has only two levels of magnitude, e.g., 

abstinent vs. smoking).

Low-intensity counseling. Low-intensity counseling refers to interventions 

that involve contact between clinicians and patients that last between 3 

and 10 minutes. If the information on length of contact is unavailable, it is 

coded based on the description of content of the clinical intervention.

Managed care organizations (MCOs). Any group implementing health care 

using managed care concepts, such as preauthorization of treatment, utilization review, system-wide quality improvement strategies, and a network 

of providers.
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Mecamylamine. A nicotine antagonist used as an antihypertensive agent. 

Mecamylamine does not have an FDA indication for treating tobacco use 

and dependence.

Meta-analysis. A statistical technique that estimates the impact of a treatment or variable across a set of related studies, publications, or investigations. 

Minimal counseling. Minimal counseling refers to interventions that involve very brief contact between clinicians and patients. It is coded based 

on the length of contact between clinicians and patients (3 minutes or less). 

If that information is unavailable, it is coded based on the content of the 

clinical intervention.

Motivation. Refers to a patient’s intent or resolve to quit. Motivation can 

be bolstered through actions, such as setting a quit date, using a contract 

with a specified quit date, reinforcing correspondence (letters mailed from 

clinical/study staff congratulating the patient on his or her decision to quit 

or on early success), and providing information about the health risks of 

smoking.

Motivational intervention. An intervention designed to increase the smoker’s motivation to quit.

Motivational interviewing (MI). A directive and patient-centered counseling

method used to increase motivation and facilitate change.

Naltrexone. An opioid receptor antagonist used in substance abuse treatment. Naltrexone does not have an FDA indication for treating tobacco use 

and dependence.

National Committee for Quality Assurance (NCQA). Reviews and accredits 

managed care organizations, develops processes for measuring health plan 

performance, and disseminates information about quality so consumers 

can make informed choices (e.g., through “report cards,” such as HEDIS).

Negative affect/depression intervention. A type of intervention designed 

to train patients to cope with negative affect after smoking cessation. The 

intensity of the interventions in this category may vary from prolonged 

counseling to the provision of information about coping with negative 
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185

moods. To receive this code, interventions target depressed mood, not simply stress. Interventions aimed at teaching subjects to cope with stressors 

are coded as problemsolving. When it is unclear whether an intervention 

is directed at negative affect/depression or at psychosocial stress, problemsolving is used as the default code.

Neuroteratogenic. The capability of some substances to cause abnormal 

development of the nervous system in the fetus.

Neurotoxicity. The capablility of some substances to cause damage to the 

nervous system.

Nicotine gum. Nicotine-containing gum, a smoking cessation aid, that delivers nicotine through the oral mucosa. It is available without a prescription.

Nicotine inhaler. Nicotine-containing inhaler, a smoking cessation aid, that 

delivers nicotine in a vapor that is absorbed through the oral mucosa. It is 

available by prescription only.

Nicotine lozenge. Nicotine-containing hard lozenge, a smoking cessation 

aid, that delivers nicotine through the oral mucosa. It is available without a 

prescription. 

Nicotine nasal spray. Nicotine-containing spray, a smoking cessation aid, 

that delivers nicotine in a mist that is absorbed in the nasal passages. It is 

available by prescription only.

Nicotine patch. A nicotine-containing patch, a smoking cessation aid, that 

delivers nicotine through the skin; available with or without a prescription. 

Nicotine replacement therapy (NRT). Refers to medications containing nicotine that are intended to promote smoking cessation. There are five NRT 

delivery systems currently approved for use in the United States. These include nicotine gum, nicotine inhaler, nicotine lozenge, nicotine nasal spray, 

and nicotine patch.

Nortriptyline. A tricyclic antidepressant identified by the Guideline Panel 

as a second-line medication for smoking cessation. Nortriptyline does not 

have an FDA indication for treating tobacco use and dependence.
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Odds ratio. The odds of an outcome on one variable, given the certain 

status of another variable(s). This ratio expresses the increase in risk of a 

given outcome if a specific variable is present.

Opioid antagonists. A class of medications that block action at opiate receptor sites. Naltrexone is one type of opioid antagonist. No opioid antagonist 

has an FDA indication for treating tobacco use and dependence.

Oral mucosa. The mucous membranes that line the mouth.

Over-the-counter (OTC). Drug or medication for which a prescription is not 

needed.

Pay for performance. An incentive program in which a health care purchaser provides additional payments or other rewards usually to a clinic or 

provider if a specified goal is met.

Person-to-person intervention. In-person or face-to-face contact between 

a clinician and a patient for the purpose of tobacco use intervention or assessment.

Physiological monitoring/biological marker feedback. A treatment by 

which a clinician provides to a tobacco user biological information, such as 

spirometry readings, carbon monoxide readings, or genetic susceptibility 

information, for the purpose of increasing abstinence from tobacco use.

Placebo. An inactive, harmless substance with no known direct beneficial 

effects. Usually used in clinical studies as a comparison to the effectiveness 

of an experimental drug or regimen.

Point prevalence. A measure of tobacco abstinence based on smoking/

tobacco use occurrence within a set period (usually 7 days), prior to a followup assessment.

Potential reduced exposure products (PREP). Products designed to reduce 

levels of tobacco intoxicants including: (1) modified tobacco products, 

(2) tobacco products that are heated rather than burned, (3) oral, lownitrosamine tobacco products, and (4) medicinal nicotine products (e.g., 

NRTs). With the exception of NRTs, little research has been conducted to 

evaluate PREPs. 
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187

Practical counseling (problemsolving/skills training). Refers to a tobacco 

use treatment in which tobacco users are trained to identify and cope with 

events or problems that increase the likelihood of their tobacco use. For 

example, quitters might be trained to anticipate stressful events and to use 

coping skills, such as distraction or deep breathing, to cope with an urge to 

smoke. Related interventions are coping skill training, relapse prevention, 

and stress management.

Primary care clinician. A clinician (e.g., in medicine; nursing; psychology; 

pharmacology; dentistry/oral health; physical, occupational, and respiratory therapy) who provides basic health care services for problems other 

than tobacco use per se. Primary care providers are encouraged to identify 

tobacco users and to intervene, regardless of whether tobacco use is the 

patient’s presenting problem.

Proactive telephone counseling. A quitline that responds to incoming calls 

and makes outbound followup calls. Following an initial request by the 

smoker or via a fax-to-quit program, the clinician initiates telephone contact to counsel the patient (see Hotline/Helpline).

Propranolol. A beta-adrenergic blocker often used as an antihypertensive 

medication. Propranolol does not have an FDA indication for treating 

tobacco use and dependence.

Psychosocial interventions. Refers to intervention strategies that are designed to increase tobacco abstinence rates due to psychological or social 

support mechanisms. These interventions comprise counseling, self-help, 

and behavioral treatment, such as rapid smoking and contingency contracting.

Purchaser. A corporation, company, Government agency, or other consortium that purchases health care benefits for a group of individuals.

Quality-adjusted life years (QALY). Measure of both the quality and the 

quantity of life lived. Used as a means of quantifying the benefits of a medical intervention.

Quit day. The day of a given cessation attempt during which a patient tries 

to abstain totally from tobacco use. Also refers to a motivational intervention, whereby a patient commits to quit tobacco use on a specified day.
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Quitline. A telephone counseling service that can provide both proactive 

telephone counseling and reactive telephone counseling (see Proactive 

Telephone Counseling and Reactive Telephone Counseling).

Randomized controlled trial. A study in which subjects are assigned to conditions on the basis of chance, and where at least one of the conditions is a 

control or comparison condition. 

Random effects modeling. A model in which both study sampling errors 

(variance) and between-study variation are included in the assessment of 

the uncertainty (confidence interval) of the results of a meta-analysis. If 

there is significant heterogeneity among the results of included studies, 

random effects models will give wider confidence intervals than fixed effect 

models.

Rapid puffing/smoking. A smoking cessation technique that involves the 

pairing of concentrated smoking with negative associations or responses 

(e.g., nausea). 

Reactive telephone counseling. Telephone counseling that provides an 

immediate response to a patient-initiated call for assistance. It is a quitline 

intended to respond only to incoming calls (see Hotline/Helpline). 

Reference group. In meta-analyses, refers to the group against which other 

groups are compared (i.e., a comparison or control group).

Relapse. Return to regular smoking by someone who has quit. A distinction is sometimes made between “relapse” and a “lapse” (or a “slip”), which 

is a return to reduced smoking or brief smoking after quitting that falls 

short of a return to regular smoking (see also Slip).

Relapse prevention. Various intervention strategies intended to prevent a 

recent quitter from returning to regular smoking.

Relaxation/breathing. An intervention strategy in which patients are 

trained in relaxation techniques, such as meditation and breathing exercises. This intervention should be distinguished from “problemsolving,” 

which includes a much wider range of stress-reduction/management strategies.
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189

Restricted environmental stimulation therapy (REST). A treatment involving 

the use of sensory deprivation to promote abstinence from tobacco use.

Return on investment (ROI). Amount of money gained or lost, including money that would have been spent for health care, in relation to the 

amount of money needed to provide the treatment.

Screening. See Clinic Screening System.

Secondhand smoke. Also known as environmental tobacco smoke (ETS). 

The smoke inhaled by an individual not actively engaged in smoking, but 

who is exposed to smoke from the lit end of a cigarette and the smoke 

exhaled by the smoker.

Second-line medications. Second-line medications are medications for 

which there is evidence of efficacy for treating tobacco dependence. They 

have a more limited role than first-line medications because: (1) the FDA 

has not approved them for a tobacco dependence treatment indication, 

and (2) there are more concerns about potential side effects than exist with 

first-line medications. Second-line treatments should be considered for use 

on a case-by-case basis after first-line treatments have been used or considered.

Selective Serotonin Re-uptake Inhibitors (SSRIs). A class of antidepressant 

used in the treatment of clinical depression that has been studied for use in 

tobacco dependence treatment. No SSRI has an FDA indication for treating 

tobacco use and dependence.

Self-efficacy. One’s beliefs about his/her capability to successfully act to 

achieve specific goals or influence events that affect one’s life.

Self-help. An intervention strategy in which the patient uses a nonpharmacologic physical aid to achieve abstinence from tobacco. Self-help strategies 

typically involve little contact with a clinician, although some strategies 

(e.g., reactive hotline/helpline) involve patient-initiated contact. Types of 

self-help materials include: pamphlets/booklets/mailings/manuals; 

videos; audios; referrals to 12-step programs; mass media, communitylevel interventions; lists of community programs; reactive telephone 

hotlines/helplines; and computer programs/Internet.
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Self-reported abstinence. Abstinence based on the patient’s claim, which 

may or may not be verified clinically by biochemical confirmation.

Sertraline. A selective serotonin re-uptake inhibitor. Sertraline does not 

have an FDA indication for treating tobacco use and dependence.

Serum nicotine. Level of nicotine in the blood. This often is used to assess 

a patient’s tobacco/nicotine self-administration prior to quitting, and to 

confirm abstinence self-reports during followup. Nicotine commonly is 

measured in urine and saliva.

Serum nicotine/cotinine levels. Level of nicotine/cotinine in the blood. Cotinine is nicotine’s major metabolite, which has a significantly longer halflife than nicotine. This often is used to estimate a patient’s tobacco/nicotine 

self-administration prior to quitting, and to confirm abstinence self-reports 

during followup. Cotinine commonly is measured in urine and saliva.

Side effects. Undesired actions or effects of a drug used in tobacco use 

treatment, such as insomnia or dry mouth.

Silver acetate. Silver acetate reacts with cigarette smoke to produce an 

unpleasant taste and has been investigated as a smoking deterrent. It is not 

approved by the FDA for this use. 

Skills training. Refers to a tobacco use treatment in which tobacco users 

are trained to identify and cope with events or problems that may increase 

the risk of tobacco use. For example, quitters might be trained to anticipate 

stressful events and to use coping skills, such as distraction or deep breathing, to cope with an urge to smoke. Related interventions are practical 

counseling, relapse prevention, and stress management.

Slip. A brief or reduced return to smoking after quitting. Also referred to as 

a “lapse” (see Relapse).

Smokeless tobacco. Any form of unburned tobacco, including chewing 

tobacco, snus, and snuff. Use of smokeless tobacco is as addictive as smoking and can cause cancer of the gum, cheek, lip, mouth, tongue, throat, and 

pancreas.
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191

Social support. Nonmedicinal support for the smoking cessation patient 

that provides personal encouragement and empathetic listening. Tobacco 

dependence treatments include two types of social supports: intratreatment 

social support and extratreatment social support.

Socioeconomic status (SES). Position of an individual or group in a population or society, usually based on income, education, or occupational 

categories. 

Specialized assessments. Refers to assessment of patient characteristics, 

such as nicotine dependence and motivation for quitting, that may allow 

clinicians to tailor interventions to the needs of the individual patient.

Stepped-care. The practice of initiating treatment with a low-intensity 

intervention and then exposing treatment failures to successively more 

intense interventions.

Sudden Infant Death Syndrome (SIDS). Unexpected and sudden death of an 

apparently healthy infant during sleep with no autopsic evidence of disease. 

It is the leading cause of death in infants between 2 weeks and 1 year of age. 

The cause is unknown, but certain risk factors have been identified, such as 

prematurity; low birth-weight; birth in winter months; and mothers who 

are very young, smoke, are addicted to a drug, or have had a recent upper 

respiratory infection. Also called “cot death” and “crib death.” 

Tailored interventions. Tailored interventions are based on a dimension or 

a subset of dimensions of the individual (i.e., weight concerns, dependency, 

etc.). See also Individualized Interventions.

The Joint Commission (TJC) (formerly Joint Commission on Accreditation 

of Healthcare Organizations, JCAHO). An independent, not-for-profit 

organization that evaluates and accredits more than 19,500 health care 

organizations in the United States, including hospitals, health care 

networks, managed care organizations, and health care organizations that 

provide home care, long-term care, behavioral health care, and laboratory 

and ambulatory care services.

Tobacco dependence. Dependence on any form of tobacco, including, but 

not exclusive to, cigarettes, pipes, cigars, and chewing tobacco.
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Tobacco treatment specialists. These specialists typically provide intensive 

tobacco interventions. Specialists are not defined by their professional affiliation or by the field in which they trained. Rather, specialists view tobacco dependence treatment as a primary professional role. Specialists possess 

the skills, knowledge, and training to provide effective interventions across 

a range of intensities, and often are affiliated with programs offering intensive treatment interventions or services.

Tobacco user. A person addicted to one or more forms of tobacco products. 

Transdermal. Refers to delivery of a substance by absorption through the 

skin. Transdermal nicotine often is used as a synonym for “nicotine patch.”

Treatment matching. Differential assignment of a patient to treatment 

based on the patient’s pretreatment characteristics. Treatment matching is 

based on the notion that particular types of tobacco users are most likely to 

benefit from particular types of treatments.

Treatment. An action or program that aims to bring about identifiable 

outcomes. For tobacco dependence, the treatment generally is clinical in 

nature and may consist of counseling and the use of medications. Also may 

be referred to as “intervention.”

Unaided quit attempts. Quit attempts made by patients, without the assistance of any clinical intervention or medications. Also known as “quitting 

cold turkey.”

Varenicline. FDA-approved, non-nicotine recommended smoking cessation medication. Its mechanism of action is thought to be a function of its 

ability to serve both as a partial nicotine receptor agonist and a nicotine 

receptor antagonist. Available by prescription only.

Vital signs. Standard patient measurements to assess the critical body functions, including blood pressure, pulse, weight, temperature, and respiratory 

rate. The first step (i.e., the first “A”) to providing smoking cessation interventions is identifying smokers. Vital signs should be expanded to include 

tobacco use status (current, former, never) or an alternative universal 

identification system in patient records.
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193

Web-based interventions. See Internet Interventions.

Weight/diet/nutrition. An intervention strategy designed to address weight 

gain or concerns about weight gain. Interventions that teach weight/diet/

nutrition management strategies, incorporate daily/weekly weight monitoring (for reasons other than routine data collection), require or suggest 

energy intake maintenance/reduction, and/or convey nutritional information/tips/counseling receive this code.

Withdrawal symptoms. A variety of unpleasant symptoms (e.g., difficulty 

concentrating, irritability, anxiety, anger, depressed mood, sleep disturbance, and craving) that occur after use of an addictive drug is reduced or 

stopped. Withdrawal symptoms are thought to increase the risk for relapse.

195

Contributors

Guideline Panel

Michael C. Fiore, MD, MPH

Panel Chair

Professor, Department of Medicine

Director, Center for Tobacco Research and Intervention

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin

Dr. Fiore completed medical school at Northwestern University and his internal medicine training at Boston City Hospital. His postgraduate education included a master’s degree in public health in epidemiology from Harvard University. Dr. Fiore received additional training in epidemiology as 

an Epidemic Intelligence Service Officer for the Centers for Disease Control and Prevention, where he completed a preventive medicine residency 

program. Dr. Fiore worked as a medical epidemiologist at the U.S. Office 

on Smoking and Health, where he contributed to a wide range of national 

research, educational, and policy projects to control the epidemic of tobacco-related diseases. He is Director of the Center for Tobacco Research and 

Intervention and a Professor of Medicine at the University of Wisconsin 

School of Medicine and Public Health. He served as Chair of the Agency 

for Healthcare Policy and Research Panel that produced the Smoking Cessation Clinical Practice Guideline No. 18 (1996) and Chair of the Public 

Health Service Panel that produced Treating Tobacco Use and Dependence: 

A Clinical Practice Guideline (2000). Dr. Fiore serves as Director (with Dr. 

Susan Curry) of a Robert Wood Johnson Foundation National Program, 

Addressing Tobacco in Health Care.

Carlos Roberto Jaén, MD, PhD, FAAFP

Panel Vice Chair

Professor and Chair, Department of Family and Community Medicine

Co-Director, Center for Research in Family Medicine and Primary Care

University of Texas Health Science Center at San Antonio

San Antonio, Texas

Dr. Jaén completed medical school at the State University of New York at 

Buffalo, and his family medicine residency and primary care research fellowship at Case Western Reserve University in Cleveland, Ohio. His graduate education included a PhD in epidemiology, with a concentration in 
Treating Tobacco Use and Dependence: 2008 Update

196

tobacco control at Roswell Park Cancer Institute. He is Professor and 

Chair of the Department of Family and Communty Medicine at the University of Texas Health Science Center at San Antonio. He also is Co-Director of the American Academy of Family Physicians-funded Center for 

Research in Family Medicine and Primary Care. Dr. Jaén, active in primary 

care and public health research since 1985, has authored more than 70 

publications on smoking cessation and related subjects, clinical preventive 

service delivery in primary care offices, and access to care by the urban 

poor and Hispanic populations. In 2005, he was appointed to the National 

Advisory Council to the Agency for Healthcare Research and Quality of 

the U.S. Public Health Service. He is a practicing family physician in the 

University of Texas Health Science Center at San Antonio and has been 

selected to the Best Doctors in America since 2002.

Timothy B. Baker, PhD

Senior Scientist

Professor, Department of Medicine

Associate Director, Center for Tobacco Research and Intervention

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin

Dr. Baker is a Professor of Medicine at the University of Wisconsin School 

of Medicine and Public Health. His principal research goals are to increase understanding of the motivational bases of addictive disorders and 

to develop and evaluate treatments for such disorders. He also is highly 

interested in developing and using technological advances to deliver effective treatments to ameliorate health problems such as addictive disorders and cancer. Dr. Baker is a long-serving member of the NIDA-E study 

section, has served as the Editor of the Journal of Abnormal Psychology, is 

the principal investigator of the University of Wisconsin Transdisciplinary 

Tobacco Use Research Center award (NIDA), and has contributed chapters 

to multiple Reports of the Surgeon General. 

William C. Bailey, MD, FACP, FCCP

Director, Lung Health Center

University of Alabama at Birmingham

Birmingham, Alabama

Dr. Bailey graduated from Tulane University Medical School in 1965. He is 

a Diplomate of the American Board of Internal Medicine in both Internal 

Medicine and Pulmonary Disease, having received certified specialty 
Contributors

197

training in these disciplines at Tulane University Medical Center and Charity Hospital of Louisiana. He has been on the faculty of the University of 

Alabama at Birmingham (UAB) since 1973. He has practiced medicine, 

taught, performed research, and been involved in administrative endeavors 

for his entire career. He has served on the Board of Directors of the American Thoracic Society and also has served on the Council of the National 

Heart, Lung, and Blood Institute. He has been a member of many editorial review boards of peer-reviewed journals and has served as a frequent 

scientific reviewer of both scientific articles and peer-reviewed research. 

He currently holds the Eminent Scholar Chair in Pulmonary Diseases and 

also is the Director of the UAB Lung Health Center, which is devoted to 

research in the prevention of lung disease.

Neal L. Benowitz, MD

Chief, Division of Clinical Pharmacology and Experimental Therapeutics

University of California‐San Francisco

San Francisco, California

Dr. Benowitz is Professor of Medicine, Psychiatry, and Biopharmaceutical 

Sciences and Chief, Division of Clinical Pharmacology and Experimental 

Therapeutics, University of California, San Francisco (UCSF). He received 

his MD from the University of Rochester School of Medicine in 1969, 

and he served as a resident in internal medicine at the Bronx Municipal 

Hospital Center from 1969 to 1971. He then completed a postdoctoral 

fellowship in clinical pharmacology at UCSF and joined the faculty at 

UCSF in 1974. His research interests have focused primarily on the human 

pharmacology and toxicology of nicotine, caffeine, and other stimulant 

drugs. He has published more than 300 research papers. Dr. Benowitz 

was a scientific editor of the 1988 United States Surgeon General’s Report 

on Smoking and Health: Nicotine Addiction, and served as a member of 

the NIH Pharmacology Study Section. Dr. Benowitz is a member of a 

number of medical societies, including the American Society for Clinical 

Investigation and the Association of American Physicians. He has served 

as President of the American Society for Clinical Pharmacology and 

Therapeutics and the Society for Research on Nicotine and Tobacco. He 

has received the Ove Ferno, Alton Ochsner, and Rawls Palmer Progress in 

Medicine awards and the Oscar B. Hunter Award in Therapeutics for his 

research on nicotine, tobacco, and health, and was the 2002 UCSF Annual 

Distinguished Clinical Research Lecturer. Dr. Benowitz is currently Director 

of the Flight Attendants Medical Research Institute Center of Excellence 
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198

at UCSF, principal investigator of the Pharmacogenetics of Nicotine Addiction Research Consortium, and Program Leader of the Tobacco Control 

Program of the UCSF Comprehensive Cancer Center.

Susan J. Curry, PhD

Director, Institute for Health Research and Policy

University of Illinois-Chicago

Chicago, Illinois

Dr. Curry is the Director of the Institute for Health Research and Policy 

and Professor of Health Policy and Administration at the University of Illinois at Chicago (UIC). Prior to joining UIC in 2001, she was Professor of 

Health Services in the School of Public Health and Community Medicine 

at the University of Washington, and Director and Senior Investigator at the 

Center for Health Studies, Group Health Cooperative. Dr. Curry’s research 

in tobacco includes studies of motivation to quit smoking; randomized 

trials of promising smoking cessation and prevention interventions; and 

evaluations of the use and cost-effectiveness of tobacco cessation treatments under different health insurance plans, and health care costs and 

utilization associated with tobacco cessation. Dr. Curry serves as Director 

(with Dr. Michael Fiore) of a Robert Wood Johnson Foundation National 

Program, Addressing Tobacco in Health Care, and heads the Helping Young 

Smokers Quit national initiative funded by the Robert Wood Johnson 

Foundation, Centers for Disease Control and Prevention, and the National 

Cancer Institute (NCI). She currently serves on the Board of Directors for 

the American Legacy Foundation and is a member of the Board of Scientific 

Advisors for NCI. 

Sally Faith Dorfman, MD, MSHSA

Associate Director, Medical Affairs, Infertility

Ferring Pharmaceuticals, Inc.

Parsippany, New Jersey

Dr. Dorfman holds a degree in economics from Harvard College, a master’s 

degree in health services administration, and an MD from Stanford University. She trained in reproductive health epidemiology as an Epidemic 

Intelligence Service Officer at the Centers for Disease Control and Prevention. She is board certified both in obstetrics and gynecology and in public 

health/general preventive medicine, and is an alumna of the Public Health 

Leadership Institute. Dr. Dorfman has consulted for state, regional, national, and international organizations, and was Commissioner of Health 
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199

for Orange County, New York, from 1988 to 1994, effectively implementing New York State’s then new Clean Indoor Air Act. She has published 

and presented extensively for professional and lay audiences, co-chaired 

the American Medical Women’s Association (AMWA) Anti-Smoking 

Task Force, chaired the AMWA Reproductive Health Initiative, and is the 

recipient of numerous honors and awards. In addition to administrative, 

research, and editorial responsibilities, Dr. Dorfman remains clinically 

active as a gynecologist.

Erika S. Froehlicher, PhD, RN, MA, MPH

Professor, Department of Physiological Nursing

Department of Epidemiology & Biostatistics

Schools of Nursing and Medicine

University of California San-Francisco

San Francisco, California

Dr. Froehlicher holds degrees in nursing with a minor in business administration from the University of Washington, Seattle, and an MPH and a PhD 

from the University of California, Los Angeles. Her areas of research and 

teaching are in the primary, secondary, and tertiary prevention (rehabilitation) of cardiovascular disease. She served as Co-Chair for the Cardiac 

Rehabilitation Guideline 1995, and as a reviewer for the Unstable Angina 

and Congestive Heart Failure Federal Guideline. Her specific research 

focus is on behavioral interventions to promote physical activity and 

exercise, women’s health issues, and international health. Her focus with 

respect to smoking is on randomized clinical trials to study the efficacy of 

nurse-managed smoking cessation in women with cardiovascular disease, 

the older American smoker, and the African-American population; as well 

as international initiatives in Korea, Jordan, and Japan.

Michael G. Goldstein, MD

Associate Director, Clinical Education and Research

Institute for Healthcare Communication

New Haven, Connecticut

Dr. Goldstein is board certified in internal medicine and psychiatry and 

currently serves as an Associate Director for Clinical Education and Research at the Institute for Healthcare Communication (IHC) in New Haven, Connecticut. The IHC is a nonprofit foundation dedicated to improving health care through enhanced clinician-patient communication. Also, 

he is an investigator at the Centers for Behavioral and Preventive Medicine 
Treating Tobacco Use and Dependence: 2008 Update

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at the Miriam Hospital in Providence, Rhode Island, and an Adjunct Professor of Psychiatry and Human Behavior at the Warren Alpert Medical 

School of Brown University. Dr. Goldstein’s primary research interests have 

included developing and testing interventions to enhance the delivery of 

smoking cessation and other preventive care interventions in primary care 

settings. Dr. Goldstein has served as a member of the Task Force on Nicotine Dependence of the American Psychiatric Association (APA) and also 

served on the APA Nicotine Dependence Practice Guideline Panel. He has 

published extensively in the areas of behavioral medicine, smoking cessation, and health care communication.

Cheryl Healton, DrPH

President and Chief Executive Officer

American Legacy Foundation

Washington, DC

Following the creation of the American Legacy Foundation in 1999, 

Dr. Healton joined the staff as the first President and Chief Executive Officer 

of this groundbreaking public health nonprofit, created by the historic 

Master Settlement Agreement between 46 state attorneys general, five U.S. 

territories, and the tobacco industry. Dr. Healton was selected for this post 

following a nationwide search, and she has worked tirelessly to further the 

foundation’s ambitious mission: “To build a world where young people 

reject tobacco and anyone can quit.” During her tenure with the Foundation, 

she has guided the highly acclaimed, national youth tobacco prevention 

counter‐marketing campaign, truth,® which has been credited in part with 

reducing youth smoking prevalence to its current 28‐year low.

Although her current focus is aimed at reducing the deadly toll of tobacco 

on Americans, Dr. Healton’s long and dynamic career in the field of public 

health has earned her national recognition and praise. She holds a doctorate from Columbia University’s School of Public Health and a master’s 

degree in public administration at New York University for health policy 

and planning. She joined the American Legacy Foundation from Columbia 

University’s Joseph L. Mailman School of Public Health in New York, 

where she served as Head of the Division of Socio‐Medical Sciences and 

Associate Dean for Program Development.
Contributors

201

Patricia Nez Henderson, MD, MPH

Vice President

Black Hills Center for American Indian Health

Rapid City, South Dakota

Dr. Nez Henderson received her bachelor of science degree in biochemistry from the University of Arizona and earned her doctor of medicine 

and master of public health degrees from Yale University. Upon graduating 

from medical school, Dr. Nez Henderson joined the Black Hills Center for 

American Indian Health, an American Indian nonprofit health organization located in Rapid City, South Dakota, where she currently serves as 

Vice President. In addition, Dr. Nez Henderson is a faculty member at 

the University of Colorado at Denver Health Sciences Center within the 

American Indian and Alaska Native Programs. For the past 7 years, her 

research interest has focused on tobacco-related issues in American Indian 

communities. Her research findings have been published in peer-reviewed 

medical journals. Through culturally appropriate and relevant research, she 

plans to provide Native communities with information that can be used for 

health planning and policy decisionmaking.

Richard B. Heyman, MD

Former Chair, Committee on Substance Abuse

American Academy of Pediatrics

Cincinnati, Ohio

A graduate of the Columbia University College of Physicians and Surgeons, Dr. Heyman practices pediatric and adolescent medicine in Cincinnati, Ohio, and serves as an Adjunct Professor of Clinical Pediatrics at the 

University of Cincinnati College of Medicine. He is a consultant to several 

adolescent chemical dependency programs and lectures widely in the area 

of substance abuse. As former Chairman of the Committee on Substance 

Abuse of the American Academy of Pediatrics, he has played a major role 

in the creation of the Academy’s educational programs and materials, as 

well as the development of policy in the area of alcohol, tobacco, and other 

drug abuse.
Treating Tobacco Use and Dependence: 2008 Update

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Howard K. Koh, MD, MPH, FACP

Harvey V. Fineberg Professor of the Practice of Public Health

Associate Dean for Public Health Practice

Director of the Division of Public Health Practice 

Harvard School of Public Health

Boston, Massachusetts

Dr. Koh graduated from Yale College and Yale University School of Medicine. He completed his postgraduate training at Boston City Hospital 

and Massachusetts General Hospital, serving as Chief Resident in both 

institutions. Dr. Koh has earned board certification in four medical fields 

(internal medicine, hematology, medical oncology, and dermatology) as 

well as a master of public health degree from Boston University School of 

Public Health. While serving as Commissioner of Public Health for the 

Commonwealth of Massachusetts (1997–2003), he oversaw the nationally 

recognized Massachusetts Tobacco Control Program. During this time, 

Massachusetts ranked as one of the healthiest states in the country. Dr. Koh 

is principal investigator of the National Cancer Institute-funded initiative 

MassCONECT (Massachusetts Community Networks to Eliminate Cancer Disparities through Education, Research, and Training), a project to 

eliminate cancer disparities in underserved communities. He has published 

more than 200 scientific articles in the medical and public health literature. 

President Bill Clinton appointed Dr. Koh to the National Cancer Advisory Board (2000–2002). Dr. Koh also has been elected to the Institute of 

Medicine (IOM) of the National Academies and is a member of the IOM 

Roundtable on Racial and Ethnic Health Disparities.

Thomas E. Kottke, MD, MSPH

Senior Clinical Investigator

HealthPartners Research Foundation

Minneapolis, Minnesota

Professor of Medicine

University of Minnesota

Consulting Cardiologist 

Regions Hospital

St. Paul, Minnesota

Dr. Kottke is a clinical cardiologist, epidemiologist, and health services 

researcher whose primary interest is describing, defining, and overcoming 

the barriers to the delivery of clinical services for the primordial, primary, 

and secondary prevention of chronic diseases. He has published widely on 
Contributors

203

the evidence that clinical support systems are necessary for physicians and 

other health care professionals to provide these services to the patients they 

serve. Dr. Kottke was a member of the first U.S. Preventive Services Task 

Force.

Harry A. Lando, PhD

Professor, Division of Epidemiology and Community Health

University of Minnesota

Minneapolis, Minesota

Dr. Lando is internationally recognized for his work in smoking cessation. 

He has been active in this field since 1969 and has published extensively 

in this area, with a total of more than 170 scientific publications. He was 

a scientific editor of the 1988 Report of the Surgeon General, The Health 

Consequences of Smoking: Nicotine Addiction and a member of the Center 

for Child Health Research Tobacco Consortium of the American Academy 

of Pediatrics. He is Deputy Regional Editor for Addiction. He has consulted 

actively with such government and voluntary agencies as the National 

Heart, Lung, and Blood Institute; the National Cancer Institute; the Centers 

for Disease Control and Prevention; the National Institute on Drug Abuse; 

the Agency for Healthcare Research and Quality; the American Cancer Society; the American Lung Association; and the World Health Organization. 

Dr. Lando is a past president of the Society for Research on Nicotine and 

Tobacco and currently chairs the SRNT Global Network Committee. He is 

a 2006 recipient of the University of Minnesota Award for Global Engagement; this award carries with it the title of “Distinguished International 

Professor.” He is serving as Vice President of the 14th World Conference on 

Tobacco OR Health, to be held in 2009 in Mumbai, India.

Robert E. Mecklenburg, DDS, MPH

Consultant, Tobacco and Public Health

Potomac, Maryland

Dr. Mecklenburg is a Diplomate of the American Board of Dental Public 

Health and an Assistant Surgeon General (ret. O-8). He organized and 

managed dental affairs for the National Cancer Institute’s (NCI) Tobacco 

Control Research Branch and was the Tobacco-Related Research and 

Development Advisor for the National Institute of Dental and Craniofacial 

Research’s Office of Science Policy and Analysis. He chaired the National 

Dental Tobacco-Free Steering Committee and was Vice-Chairman of the 

Dentistry Against Tobacco Section/Tobacco and Oral Health Committee of 
Treating Tobacco Use and Dependence: 2008 Update

204

the FDI World Dental Federation. He chaired the committee on noncancer 

oral effects of tobacco for the first Surgeon General’s report on smokeless 

tobacco. He was the principal author of the NCI publications, Tobacco 

Effects in the Mouth and How to Help Your Patients Stop Using Tobacco: 

A Manual for the Oral Health Team. Dr. Mecklenburg has published and 

lectured widely in the United States and abroad about dental professionals’ 

involvement in the creation of a tobacco-free society.

Robin Mermelstein, PhD

Deputy Director, Institute for Health Research and Policy

Director, Center for Health Behavior Research

Professor, Department of Psychology 

University of Illinois-Chicago

Chicago, Illinois

Dr. Mermelstein is Professor of Psychology, Director of the Center for 

Health Behavior Research, and Deputy Director of the Institute for Health 

Research and Policy at the University of Illinois at Chicago. She holds a 

PhD in clinical and community psychology from the University of Oregon. Her research interests fall broadly in the area of tobacco use, with 

studies ranging from longitudinal examinations of the etiology of youth 

smoking and interventions for adolescents to stop smoking to cessation 

interventions for adult smokers. Dr. Mermelstein has been the principal 

investigator on several grants from the National Cancer Institute (NCI) 

investigating trajectories of adolescent smoking, with a focus on social and 

emotional contextual factors. In addition, she has been funded by the Centers for Disease Control and Prevention to examine factors related to youth 

smoking, and by the National Heart, Lung, and Blood Institute and NCI 

for studies of adult smoking cessation. Dr. Mermelstein was the Director of 

the Robert Wood Johnson Foundation’s (RWJF) Program Office, A Partners with Tobacco Use Research Centers: A Transdisciplinary Approach to 

Advancing Science and Policy Studies. As part of this program, the RWJF 

collaborated with both NCI and the National Institute on Drug Abuse in 

funding the Transdisciplinary Tobacco Use Research Centers.
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205

Patricia Dolan Mullen, DrPH

Professor of Health Promotion and Behavioral Sciences

University of Texas School of Public Health

Houston, Texas

Dr. Mullen received her graduate training at the University of California, 

Berkeley, School of Public Health and has extensive experience in managed 

care. Her tobacco cessation research has focused on pregnant and postpartum women (non-Hispanic white, African American, and Hispanic) from 

urban and rural environments, who were both privately insured and covered by Medicaid. She also has collaborated on smoking cessation research 

with international populations. Dr. Mullen served on the U.S. Expert 

Panel for the Content of Prenatal Care and on research advisory panels on 

prenatal smoking cessation for the National Institutes of Health, Centers 

for Disease Control and Prevention, the American Cancer Society, and the 

Robert Wood Johnson Foundation Smoke-Free Families Program. She has 

conducted systematic reviews and meta-analyses of smoking cessation programs for pregnant women and other topics and served as a member and 

Vice-Chair of the U.S. Community Preventive Services Task Force. 

C. Tracy Orleans, PhD

Senior Scientist and Distinguished Fellow

Robert Wood Johnson Foundation

Princeton, New Jersey

Dr. Orleans has led or co-led the Robert Wood Johnson Foundation 

(RWJF) public policy- and health care system-based grant making in the 

areas of tobacco control, physical activity promotion, childhood obesity 

prevention, and chronic disease management. She led the Foundation’s 

Health & Behavior Team and has developed and/or managed numerous 

RWJF national initiatives, including Addressing Tobacco in Healthcare, 

Smoke-Free Families, Helping Young Smokers Quit, Bridging the Gap/

Impact Teen, Substance Abuse Policy Research, Improving Chronic Illness 

Care, Active Living Research, and Healthy Eating Research. An internationally known clinical health psychologist, Dr. Orleans has authored or 

co-authored more than 200 publications; contributed to several Surgeon 

General’s reports; served on numerous journal editorial boards, national 

scientific panels, and advisory groups (e.g., U.S. Preventive Services Task 

Force, Institute of Medicine, National Commission on Prevention Priorities); 

and as President of the Society of Behavioral Medicine. 
Treating Tobacco Use and Dependence: 2008 Update

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Lawrence Robinson, MD, MPH

Deputy Health Commissioner

Philadelphia Department of Public Health

Health Promotion/Disease Prevention

Philadelphia, Pennsylvania

A graduate of Harvard College, Dr. Robinson received his MD from the 

University of Pennsylvania School of Medicine. He received his MPH and 

completed a residency in preventive medicine at Johns Hopkins University. 

He was a resident and faculty member at Rush and Columbia University 

while performing his internal medicine training. As Deputy Commissioner 

for Health Promotion/Disease Prevention for the Philadelphia Department of Public Health, Dr. Robinson is responsible for the development, 

planning, implementation, and evaluation of various programs delivering 

medical, chronic disease prevention, and health education services. Local antitobacco projects include banning vending machines, assisting the 

county jail move to a smoke-free environment, Nicotrol Patch replacement, 

and the American Cancer Society Fresh Start Program. This train-thetrainer program was provided to the mentally ill and other targeted populations. Dr. Robinson also is a board member of the Pennsylvania American Cancer Society and Chairman of the State Tobacco Core Team. He is a 

member of various groups, organizations, and agencies in the community 

working on issues such as the State Tobacco Settlement (No Butts/Do the 

Right Thing) and smoking prevention for youth and specific populations, 

such as pregnant women.

Maxine L. Stitzer, PhD

Professor, Department of Psychiatry and Behavioral Sciences

Behavioral Biology Research Center

Johns Hopkins/Bayview Medical Center

Baltimore, Maryland

Dr. Stitzer received her PhD in psychology and training in psychopharmacology from the University of Michigan. At Johns Hopkins University, she 

has developed a varied and extensive grant-supported research program 

focusing on both pharmacological and behavioral approaches to the treatment of substance abuse. Her many publications reflect active research 

interests in both illicit drug abuse and tobacco dependence. She has served 

as President of the Division on Psychopharmacology and Substance Abuse 

of the American Psychological Association, President of the Society for Research on Nicotine and Tobacco, and as a member of the Board of Directors of the College on Problems of Drug Dependence.
Contributors

207

Anthony C. Tommasello, PhD, MS 

Director, Office of Substance Abuse Studies

University of Maryland School of Pharmacy

Baltimore, Maryland

Dr. Tommasello, a pharmacist, is an Associate Professor in the Department of Pharmaceutical Health Services Research at the University of 

Maryland School of Pharmacy and Director, Office of Substance Abuse 

Studies, which he founded. He received his PhD in policy sciences from 

the University of Maryland, Baltimore County, and has worked in the 

addiction field since 1973. He is active in clinical and policy research and 

in addictions treatment and has created educational programs that have 

served as national models for pharmacists and other health and human 

service workers. Dr. Tommasello is President of the Maryland Pharmacists’ 

Education and Advocacy Council, which provides advocacy and treatment 

referrals for impaired pharmacists. He has published in the areas of general 

principles of assessment and treatment, methadone maintenance care, and 

adolescent drug abuse and addiction and the pharmacist’s role in substance 

abuse and addiction management. 

Louise Villejo, MPH, CHES

Director, Patient Education Office

Office of Public Affairs

University of Texas M.D. Anderson Cancer Center

Houston, Texas

As Director of the Patient Education Office at the M.D. Anderson Cancer 

Center, Ms. Villejo is responsible for the design, implementation, evaluation, and management of institution-wide patient and family education 

programs. She has designed and implemented Patient/Family Learning 

Centers as well as award-winning, disease-specific patient education programs, and produced more than 100 patient education print materials and 

videotapes. For the past 10 years, she has served on the National Cancer 

Institute’s Advisory Boards and Patient Education Network’s Steering Committee, and on numerous other Federal and private advisory and planning 

boards and committees. Ms. Villejo’s publications include articles on cancer 

patient education and cultural diversity in health care.
Treating Tobacco Use and Dependence: 2008 Update

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Mary Ellen Wewers, PhD, MPH, RN

Professor, College of Public Health

The Ohio State University

Columbus, Ohio

Dr. Wewers, an Adult Nurse Practitioner, received her PhD in nursing 

from the University of Maryland and an MPH from Harvard University. 

She has been funded by the National Institutes of Health (NIH) to investigate reinforcement for nicotine in both human and animal models of 

dependence. Her current NIH-funded research examines nurse-managed 

tobacco cessation interventions in underserved groups. Dr. Wewers is past 

Chair of the Nursing Assembly of the American Thoracic Society and a 

past member of the Society’s Board of Directors. She serves as Co-Program 

Leader for Cancer Control at The Ohio State University Comprehensive 

Cancer Center.
Contributors

209

Statistical Consultant

Victor Hasselblad, PhD

Statistical Methodologist

Duke Clinical Research Institute

Duke University

Durham, North Carolina

Project Staff

Bruce Christiansen, PhD

Project Director

Center for Tobacco Research and 

Intervention

University of Wisconsin School of 

Medicine and Public Health

Madison, Wisconsin

Megan Piper, PhD

Project Scientist

Center for Tobacco Research and 

Intervention

University of Wisconsin School of 

Medicine and Public Health

Madison, Wisconsin

Doug Jorenby, PhD

Project Scientist

Center for Tobacco Research and 

Intervention

University of Wisconsin School of 

Medicine and Public Health

Madison, Wisconsin

Wendy Theobald, PhD

Senior Research Associate

Center for Tobacco Research and 

Intervention

University of Wisconsin School of 

Medicine and Public Health

Madison, Wisconsin

Cathlyn Leitzke, MSN, RN-C

Senior Research Associate

Center for Tobacco Research and 

Intervention

University of Wisconsin School of 

Medicine and Public Health

Madison, Wisconsin

Michael Connell

Project Database Administrator

Center for Tobacco Research and 

Intervention

University of Wisconsin School of 

Medicine and Public Health

Madison, Wisconsin

Project Administrative Staff

David Fraser, Assistant Project 

 Director

Barb Bienborn

Carlos Edge 

Linda Kurowski

Marie Larson

Margaret Sheldon

Center for Tobacco Research and 

Intervention

University of Wisconsin School of 

Medicine and Public Health

Madison, Wisconsin
Treating Tobacco Use and Dependence: 2008 Update

210

Guideline Liaisons

Ernestine W. Murray, RN, BSN, MAS, 

Project Officer

Agency for Healthcare Research and 

Quality

Rockville, Maryland

Glen Bennett, MPH, CHES

National Heart, Lung, and Blood 

Institute

Bethesda, Maryland

Stephen Heishman, PhD

National Institute on Drug Abuse

Rockville, Maryland

Corinne Husten, MD, MPH*

Now at: Partnership for Prevention

Washington, DC

Formerly at: Centers for Disease

 Control and Prevention

Atlanta, Georgia

Glen Morgan, PhD

National Cancer Institute

Bethesda, Maryland

Christine Williams, MEd

Agency for Healthcare Research and 

Quality

Rockville, Maryland 

Guideline Consortium 

Sponsors

Agency for Healthcare Research and 

Quality

Rockville, Maryland

American Legacy Foundation

Washington, DC

Centers for Disease Control and

Prevention

Atlanta, Georgia

National Cancer Institute

Bethesda, Maryland

National Heart, Lung, and Blood

 Institute

Bethesda, Maryland

National Institute on Drug Abuse

Rockville, Maryland

The Robert Wood Johnson 

Foundation

Princeton, New Jersey

Center for Tobacco Research and

Intervention

University of Wisconsin School of

Medicine and Public Health

Madison, Wisconsin
Contributors

211

Contract Support

The Scientific Consulting Group, Inc.

Gaithersburg, Maryland

Marcia Feinleib

Project Director

Joanne Brodsky

Managing Editor

Eric Doty

Art Production Manager

Article Reviewers

Adrian Coon

Scott Hagemann

Christine Harbin

Scott Johnson

Erin Josen

Andrew Kilgust

Shriya Kothur

Sean Ryan

Maurice Shaw

Center for Tobacco Research and

Intervention

University of Wisconsin School of

Medicine and Public Health

Madison, Wisconsin

Peer Reviewers

Karen Ahijevych, PhD, RN 

Professor and Associate Dean for 

Academic Affairs 

The Ohio State University 

Columbus, Ohio

Jasjit Ahluwalia, MD, MPH, MS

Executive Director, Office of 

Clinical Research

University of Minnesota Academic

Health Center

Minneapolis, Minnesota

Debra Annand, BSPH

Project Director

American Lung Association of DC

Representing: DC Tobacco-Free 

Families Campaign 

Washington, DC

Linda Bailey, JD, MHS

President and Chief Executive 

Officer

Representing: North American 

Quitline Consortium

Phoenix, Arizona

Dianne Barker, MHS 

President and Chief Executive 

Officer 

Barker Bi-Coastal Health 

Consultants

Los Angeles, California
Treating Tobacco Use and Dependence: 2008 Update

212

Bruce Bender, PhD

Professor, National Jewish Medical

 and Research Center

Representing: American Thoracic

 Society

New York, New York

Georges G. Benjamin, MD, FACP, 

FACEP(E) 

Executive Director

Representing: American Public 

Health Association 

Washington, DC

Stella Bialous, DrPH, RN, MScN

President, Tobacco Policy 

 International

Representing: Tobacco Free Nurses

San Francisco, California

Alan Blum, MD, FAAFP 

Director

University of Alabama Center for

 the Study of Tobacco and Society

Tuscaloosa, Alabama

Thomas Brandon, PhD

Professor and Director, Tobacco

 Research

Moffitt Cancer Center & Research 

Institute

University of South Florida

Tampa, Florida

David M. Burns, MD 

Professor 

University of California-San Diego

San Diego, California

Michael Caldwell, MD, MPH

Commissioner of Health

Dutchess County Department of

 Health, New York

Representing: National Associa-

 tion of County and City Health

 Officials

Washington, DC

Doug Campos-Outcalt, MD, MPA

President, Arizona Academy of

 Family Physicians

University of Arizona 

Representing: American Academy

 of Family Physicians 

Leawood, Kansas

Matthew Carpenter, PhD

Assistant Professor

Medical University of 

 South Carolina

Representing: American College of

 Chest Physicians

Northbrook, Illinois

Sally Carter, MSW, LSW 

Director of Planning and 

 Cessation Services 

Oklahoma State Department 

 of Health

Oklahoma City, Oklahoma

Moon Chen, Jr., PhD, MPH

Associate Director for Cancer 

 Prevention and Control 

UC-Davis Cancer Center

Representing: Asian American 

 Network for Cancer Awareness,

 Research, and Treatment

Sacramento, California
Contributors

213

Paul Cinciripini, PhD 

Professor 

University of Texas M.D. Anderson

 Cancer Center 

Houston, Texas

Nathaniel Cobb, MD

Chief, Chronic Disease Branch,

 Indian Health Service (IHS) 

Representing: Indian Health 

 Service

Albuquerque, New Mexico

K. Michael Cummings, MD, PhD

Chairman, Department of 

 Health Behavior 

Roswell Park Cancer Institute 

Buffalo, New York 

Ronald Davis, MD

President, American Medical 

 Association

Director, Center for Health 

 Promotion & Disease Prevention

Henry Ford Health System

Detroit, Michigan

Harriet De Wit, PhD 

Professor

University of Chicago

Chicago, Illinois

Jacob Delarosa, MD

Chief, Cardiothoracic Surgery

Idaho State University

Pocatello, Idaho

Carlo C. DiClemente, PhD 

Lipitz Professor 

University of Maryland Baltimore

 Campus 

Baltimore, Maryland

Norman Edelman, MD

Chief Medical Officer

Stony Brook University

Representing: American Lung 

 Association

New York, New York

Marilyn W. Edmunds, PhD, NP

President, Nurse Practitioner 

 Alternatives, Inc. 

Representing: American College of 

Nurse Practitioners

Arlington, Virginia 

Michael Eriksen, ScD

Professor and Director, Institute of 

Public Health

Georgia State University

Atlanta, Georgia

Linda Hyder Ferry, MD, MPH

Associate Professor

Loma Linda University School of

 Public Health

Representing: American College of

 Preventive Medicine

Washington, DC

Jacquelyn Fried, RDH, MS 

Associate Professor and Director

University of Maryland 

 Dental School

Baltimore, Maryland
Treating Tobacco Use and Dependence: 2008 Update

214

Thomas Frieden, MD, MPH

Commissioner, Department of

 Health and Mental Hygiene

New York, New York

Joseph Giaimo, DO, FCCP, FACOI

Representing: American Osteo-

 pathic Association

Chicago, Illinois

Sam Giordano, MBA, RRT, FAARC

Executive Director and 

 Chief Executive Officer

Representing: American Associa-

 tion for Respiratory Care

Irving, Texas

Thomas Glynn, PhD 

Director, Cancer Science and

 Trends

Director, International Cancer

 Control

Representing: American Cancer

 Society

Washington, DC

Neil E. Grunberg, PhD

Professor 

Uniformed Services University of

 the Health Sciences

Bethesda, Maryland

Sharon Hall, PhD 

Professor in Residence 

University of California-

 San Francisco 

San Francisco, California

Helen Ann Halpin, ScM, PhD

Professor 

University of California-Berkeley

Berkeley, California

Kim Hamlett-Berry, PhD 

Director, Public Health National

 Prevention Program

Representing: Department of 

 Veterans Affairs 

Washington, DC

Dorothy K. Hatsukami, PhD 

Director, Transdisciplinary Tobacco

 Use Research Center 

University of Minnesota 

 Cancer Center

Minneapolis, Minnesota 

 

Jack Hollis, PhD 

Senior Investigator 

Kaiser Permanente Colorado

Denver, Colorado

Kimberly Horn, EdD, MSW

Robert C. Byrd Associate Professor

 of Community Medicine

Associate Director of Population

 Health 

Mary Babb Randolph Cancer 

 Center

West Virginia University

Morgantown, West Virginia

Thomas Houston, MD 

Director, OhioHealth Nicotine 

 Dependence Program 

Columbus, Ohio
Contributors

215

John Hughes, MD

Professor

University of Vermont

Burlington, Vermont

Richard D. Hurt, MD 

Director, Nicotine Dependence

 Center

Mayo Clinic

Rochester, Minnesota

Paul Jarris, MD, MBA 

Executive Director 

Representing: Association of State

 and Territorial Health Officials

Arlington, Virginia

Martin Jarvis, DSc

Professor Emeritus 

Department of Epidemiology and 

Public Health

University College London

London, England

Peter Kaufmann, PhD

Leader, Behavioral Medicine and

 Prevention Scientific Research

 Group 

National Heart, Lung, and Blood

 Institute

Representing: The Society of 

 Behavioral Medicine

Milwaukee, Wisconsin

Jonathan D. Klein, MD, MPH

Acting Chief, Adolescent Medicine

 Division

Department of Pediatrics

AAP Julius B. Richmond Center of

 Excellence for Children

University of Rochester

Representing: American Academy

 of Pediatrics

Elk Grove Village, Illinois

 

Robert C. Klesges, PhD 

Professor

University of Tennessee Health 

 Science Center

St. Jude Children’s Research 

 Hospital

Memphis, Tennessee

Connie Kohler, DrPH

Associate Professor

University of Alabama-Birmingham

Birmingham, Alabama

B. Waine Kong, PhD, JD 

Chief Executive Officer

Representing: Association of Black 

Cardiologists

Atlanta, Georgia

 

Elizabeth Kraft, MD, MHS

Medical Director, Provider 

 Education and Resource Tobacco

 Program

Representing: Colorado Clinical

 Guidelines Collaborative

Lakewood, Colorado
Treating Tobacco Use and Dependence: 2008 Update

216

Jerry A. Krishnan, MD, PhD 

Associate Professor

University of Chicago Medical 

 Center

Representing: American Heart 

 Association

Dallas, Texas

Scott Leischow, PhD

Professor

University of Arizona

Tucson, Arizona

Caryn Lerman, PhD 

Mary W. Calkins Professor 

University of Pennsylvania School

 of Medicine

Philadelphia, Pennsylvania

Sandra Zelman Lewis, PhD

Assistant Vice President, Health and

 Science Policy/Quality 

American College of Chest 

 Physicians

Northbrook, Illinois

Edward Lichtenstein, PhD

Senior Scientist

Oregon Research Institute

Eugene, Oregon

Henri R. Manasse, Jr., PhD, ScD, RPH

Executive Vice President and Chief

 Executive Officer 

Representing: American Society of 

Health-System Pharmacists

Bethesda, Maryland

Marc Manley, MD, MPH

Vice President and Medical 

 Director

BlueCross BlueShield of Minnesota

St. Paul, Minnesota

James R. Marshall, PhD 

Senior Vice President and Chair,

 Department of Cancer Prevention

 and Population Sciences 

Roswell Park Cancer Institute 

Representing: American Society of

 Preventive Oncology

Madison, Wisconsin

Patrick E. McBride, MD, MPH

Professor 

Co-Director, Preventative 

 Cardiology Program

University of Wisconsin School of 

Medicine and Public Health

Madison, Wisconsin

 

Robert K. McLellan, MD, MPH, 

FACOEM, FAAFP 

Medical Director, DartmouthHitchcock Medical Center 

 Employee Health System 

Representing: American College

 of Occupational and 

 Environmental Medicine

Elk Grove Village, Illinois

Cathy Melvin, PhD, MPH

Faculty Director, Lineberger 

 Comprehensive Cancer Center

University of North Carolina-

 Chapel Hill

Representing: Smokefree Families

 National Partnership

Chapel Hill, North Carolina
Contributors

217

Norman Montalto, DO, FAAFP

Medical Director

Wells Fargo TPA 

West Virginia University

Morgantown, West Virginia

Claudia Morrissey, MD, MPH

President Elect

Representing: American Medical 

Women’s Association

Philadelphia, Pennsylvania

Mildred Morse, JD, CTAS 

President, Morse Enterprises 

National Tobacco Independence

 Campaign 

Washington, DC

Myra Muramoto, MD, MPH

Associate Professor

Family and Community Medicine,

 Public Health

University of Arizona Colleges of

 Medicine & Public Health

Tucson, Arizona

Matthew L. Myers, JD 

President and Chief Executive 

 Officer

Representing: Campaign for 

 Tobacco-Free Kids

Washington, DC 

 

Raymond Niaura, PhD 

Professor

Warren Alpert Medical School of

 Brown University 

Representing: Society for Research

 on Nicotine and Tobacco

Madison, Wisconsin

Lloyd F. Novick, MD, MPH

President

Representing: Association for 

 Prevention Teaching and Research

Washington, DC 

Judy Ockene, PhD, MEd 

Professor 

University of Massachusetts 

 Medical School

Worcester, Massachusetts 

Stephanie O’Malley, PhD

Professor 

Yale University School of Medicine

New Haven, Connecticut

Deborah Ossip-Klein, PhD 

Director, Smoking Research 

 Program

University of Rochester Medical

 Center

Rochester, New York

Kenneth Perkins, PhD

Professor 

University of Pittsburgh

Pittsburgh, Pennsylvania

Allan Prochazka, MD, MSc

Assistant Chief 

Denver VA Medical Center

Representing: Society of General

 Internal Medicine

Washington, DC
Treating Tobacco Use and Dependence: 2008 Update

218

Kathleen Rankin, DDS 

Baylor College of Dentistry 

Texas A&M University Health 

 System Science Center 

Representing: American Dental 

 Association

Chicago, Illinois

Bob Rehm, MBA

Vice President, Public Health and

 Clinical Strategies

Representing: America’s Health

 Insurance Plans

Washington, DC

Stephen Rennard, MD

Larson Professor 

University of Nebraska Medical

 Center

Omaha, Nebraska

Robert Richards, MA, CADCIII, NCACII

NAADAC Northwest Regional 

 Vice President

Representing: The Association for

 Addiction Professionals

Alexandria, Virginia

Nancy Rigotti, MD 

Professor of Medicine, Harvard

 Medical School 

Representing: American College 

 of Physicians

Philadelphia, Pennsylvania

Diane Roberts, DrPH

Associate Professor 

Indiana University East

Richmond, Indiana

Gennette Robinson, RDH, MS

Immediate Past President 

Representing: National Dental 

 Hygienists’ Association

Chicago, Illinois

Patricia A. Rowell, PhD, RN, CNP

Representing: American Nurses

 Association

Silver Spring, Maryland

 

Linda Sarna, DNSc, RN, FAAN

Associate Professor

University of California-

 Los Angeles School of Nursing

Representing: TobaccoFree Nurses

San Francisco, California

 

Steve A. Schroeder, MD

Distinguished Professor of Health

 and Health Care, Department of 

Medicine

Director, Smoking Cessation

University of California-

 San Francisco

San Francisco, California

Herbert Severson, PhD 

Senior Research Scientist 

Oregon Research Institute 

Eugene, Oregon

Gerard A. Silvestri, MD, MS, FCCP

Professor 

Medical University of South 

 Carolina

Representing: American College of

 Chest Physicians 

Northbrook, Illinois
Contributors

219

Carol Southard, RN, MSN

Smoking Cessation Specialist

Northwest Memorial Hospital

Representing: American Dental

 Hygienist Association

Chicago, Illinois

Bonnie Spring, PhD, ABPP

Professor 

Northwestern University

Representing: The Society of 

 Behavioral Medicine

Milwaukee, Wisconsin

Lindsay Stead, MA, MSc 

Review Coordinator 

Cochrane Tobacco Addiction

 Group 

University of Oxford 

Headington, Oxford

Jan Stine, BSEd

Tobacco Program Consultant

Ohio Department of Health

Columbus, Ohio

Steven Sussman, PhD 

Professor 

University of Southern California

Los Angeles, California 

 

Amber Hardy Thornton, MPH, CHES

Executive Vice President for 

 Program Development

American Legacy Foundation

Washington, DC

Olga Tompkins, MPH, RN, COHNS/SM, FAAOHN

Representing: American Associa-

 tion of Occupational Health Nurses

Atlanta, Georgia

 

Richard W. Valachovic, DMD, MPH

Executive Director

Representing: American Dental

 Education Association 

Rudy Valenzuela, FSP, MSN, RN, FNP-C

President and Chief Executive 

 Officer, FSP Health Ministries

Representing: National Associa-

 tion of Hispanic Nurses

Washington, DC

Frank Vitale, MA 

Senior Lecturer, Pharmaceutical

 Sciences 

University of Pittsburgh 

Representing: Pharmacy Partner-

 ship for Tobacco Cessation

Bethesda, Maryland

Kenneth E. Warner, PhD

Director

University of Michigan Tobacco

 Research Network

Ann Arbor, Michigan

Larry N. Williams, DDS, MAGD

Captain, Dental Corps

U.S. Navy

Great Lakes, Illinois
Treating Tobacco Use and Dependence: 2008 Update

220

David Willoughby, MA

Chief Executive Officer

Clearway Minnesota

Minneapolis, Minnesota

Richard Windsor, PhD, MS, MPH

Professor

George Washington University

School of Public Health and 

 Health Services

Washington, DC

Richard A. Yoast, PhD

Director, Reducing Underage

 Drinking Through Coalitions

American Medical Association

Chicago, Illinois

Kathy Zaiken, PharmD

Assistant Professor 

Massachusetts College of Pharmacy

 and Health Sciences 

Representing: American Association of Colleges of Pharmacy

Alexandria, Virginia
Appendixes

223

Appendix A. Financial Disclosure for Panel 

Members, Liaisons, and Peer Reviewers 

Panel Members

The evaluation of conflict for the 2008 Guideline Update comprised a twostage procedure designed to obtain increasingly detailed and informative 

data on potential conflicts over the course of the Guideline development 

process. 

1. In July 2006 and prior to the initial meeting in October 2006, Panel 

members completed a general screen, reporting any potential conflicts over 

the previous 5 years. Where potential conflicts existed, Panel members provided a narrative listing of the relevant organizations and types of conflict. 

Panel members were asked to update this screen as new information or 

potential conflicts became known. 

2. Prior to the second in-person Panel meeting in June 2007, and before 

any decisions regarding Panel recommendations were made, Panel members were required to complete a more exhaustive disclosure process for 

calendar years 2005, 2006, and 2007, based on the United States Department of Health and Human Services, PHS Title 42, Chapter 1, Part 50 

guidelines for the conduct of research (ori.hhs.gov/policies/fedreg42cfr50.

shtml). Moreover, Panel members were asked to update this report as new 

information or potential conflicts became known. In keeping with the 

PHS-based guidelines, a potential conflict was designated as “significant” if 

one or more of three criteria were met:

A. Net reportable compensation in excess of $10,000 in any reporting 

year to the Panel member, spouse, or dependent child for outside activities from any entity whose interests may be affected by the recommendations in the Guideline (excluding public or nonprofit entities).

B. Leadership as an officer, director, or trustee in any reporting year by 

the Panel member, spouse, or dependent child in any entity whose 

interests may be affected by the recommendations in the Guideline 

(excluding public or nonprofit entities).
Treating Tobacco Use and Dependence: 2008 Update

224

C. Ownership interests either in excess of $10,000 or 5 percent of the 

business in any reporting year by the Panel member, spouse, or 

dependent child in any entity whose interests may be affected by the 

recommendations in the Guideline (excluding public or nonprofit 

entities).

Panel members were asked to complete this PHS-based report for 3 calendar years (2005, 2006, 2007), that comprised both the 18-month period 

before the Guideline Panel was constituted, as well as the full period of 

Guideline development. For any significant conflict that was disclosed, 

Panel members provided a detailed description of the relevant organizational tie, including categorizing the amount of compensation or financial 

interests involved. Of the Panel members listed in this document, 21 of 24 

had no significant financial interests as defined by the PHS-based criteria. 

In addition to these mandatory disclosures regarding compensation, leadership, and ownership, members were asked to disclose any other information that might be disclosed in a professional publication. 

Three Panel members whose disclosures exceeded the PHS criteria for 

significant financial interest were recused from Panel deliberations relating 

to their areas of conflict; one additional Panel member voluntarily recused 

himself.

The following is a summary listing for any of the years 2005, 2006, and 

2007 of all significant financial interests as defined above, as well as any additional disclosures Panel members chose to make.

William C. Bailey reported significant financial interests in the form of 

compensation from three different pharmaceutical companies in 2006 and 

two in 2007 for speaking engagements. 

Timothy B. Baker reported no significant financial interests. Under additional disclosures, he reported that he has served as a co-investigator on 

research studies at the University of Wisconsin that were sponsored by four 

pharmaceutical companies. 

Neal L. Benowitz reported significant financial interest in the form of 

compensation from one pharmaceutical company for each of the years 

2005–2007, as well as stock ownership in one pharmaceutical company. 
Appendixes

225

Under additional disclosures, he reported providing expert testimony in 

lawsuits against tobacco companies.

Susan J. Curry reported no significant financial interests and no additional 

disclosures.

Sally Faith Dorfman reported no significant financial interests. Under additional disclosures, she reported her employment by Ferring Pharmaceuticals, Inc., a company whose business does not relate to treating tobacco 

dependence.

Michael C. Fiore reported no significant financial interests. Under additional disclosures, he reported that he served as an investigator on research 

studies at the University of Wisconsin (UW) that were supported wholly or 

in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 

1998, the UW appointed him to a named Chair, which was made possible 

by an unrestricted gift to the UW from GlaxoWellcome.

Erika S. Froehlicher reported no significant financial interests and no additional disclosures.

Michael G. Goldstein reported no significant financial interests. Under additional disclosures, he reported that his employer received support from 

Bayer Pharmaceutical prior to 2005 and that he was employed by Bayer 

Pharmaceutical Corporation prior to January 1, 2005. His organization 

received payments for his professional services from two pharmaceutical 

companies and one commercial Internet smoking cessation site during the 

period 2005–2007.

Cheryl Healton reported no significant financial interests and no additional disclosures.

Patricia Nez Henderson reported no significant financial interests and no 

additional disclosures.

Richard B. Heyman reported no significant financial interests and no additional disclosures.
Treating Tobacco Use and Dependence: 2008 Update

226

Carlos Roberto Jaén reported no significant financial interests and no additional disclosures.

Howard K. Koh reported no significant financial interests and no additional disclosures.

Thomas E. Kottke reported no significant financial interests and no additional disclosures.

Harry A. Lando reported no significant financial interests. Under additional disclosures, he reported serving on an advisory panel for a new tobacco 

use cessation medication and attending 2-day meetings in 2005 and 2006 

as a member of this panel.

Robert E. Mecklenburg reported no significant financial interests. Under 

additional disclosures, he reported assisting Clinical Tools, Inc., through 

a governmental contract to develop a PHS 2000 Guideline-based Internet 

continuing education course. 

Robin Mermelstein reported no significant financial interests and no additional disclosures.

Patricia Dolan Mullen reported no significant financial interests and no 

additional disclosures.

C. Tracy Orleans reported significant financial interests in the form of a 

dependent child who owns pharmaceutical stock, and no additional disclosures. 

Lawrence Robinson reported no significant financial interests and no additional disclosures.

Maxine L. Stitzer reported no significant financial interests. Under additional disclosures, she reported participation on a pharmaceutical scientific 

advisory panel for a new tobacco use cessation medication.

Anthony C. Tommasello reported no significant financial interests and no 

additional disclosures.
Appendixes

227

Louise Villejo reported no significant financial interests and no additional 

disclosures.

Mary Ellen Wewers reported no significant financial interests and no additional disclosures.

Liaisons

Liaisons followed the same process as Panel members in reporting significant financial interests. Their disclosures are summarized below:

Glen Bennett reported no significant financial interests and no additional 

disclosures.

Stephen Heishman reported no significant financial interests and no additional disclosures.

Corinne Husten reported no significant financial interests and no additional disclosures.

Glen Morgan reported no significant financial interests and no additional 

disclosures.

Ernestine W. Murray reported no significant financial interests and no additional disclosures.

Christine Williams reported no significant financial interests and no additional disclosures.

Peer Reviewers

Peer reviewers were required to report significant financial interests at the 

time they submitted their peer reviews. The interests were reviewed prior 

to the adjudication of each reviewer’s comments. Any significant financial 

interests are noted below their listing in the Contributors Section of this 

Guideline.
Treating Tobacco Use and Dependence: 2008 Update

228

Outside Comments

The availability of the draft Guideline report for review was announced 

in the Federal Register on September 28, 2007 (Volume 72, Number 188). 

Individuals who had informed Panel members or staff that they wished the 

opportunity to review the document were provided with an opportunity 

to do so. All those submitting comments were asked to disclose significant 

financial interests at the time their comments were submitted. Prior to each 

set of comments being considered and adjudicated, the disclosure information (or lack of disclosure) was noted and taken into consideration. 
229

Appendix B. Helpful Web Site Addresses

The inclusion of Web sites in this appendix is intended to assist readers in 

finding additional information regarding the treatment of tobacco use and 

dependence and related topics and does not constitute endorsement of the 

contents of any particular site. All Web sites listed are either Governmentsponsored organizations or nonprofit foundations.

Addressing Tobacco in Healthcare (formerly Addressing Tobacco in Managed Care): www.atmc.wisc.edu

Agency for Healthcare Research and Quality: www.ahrq.gov

American Academy of Family Physicians: www.aafp.org

American Cancer Society: www.cancer.org

American College of Chest Physicians: www.chestnet.org

American Legacy Foundation: www.americanlegacy.org

American Lung Association: (maintains profiles of state tobacco control 

activities): www.lungusa.org

American Psychological Association: www.apa.org

Association for the Treatment of Tobacco Use and Dependence: 

www.attud.org

Campaign for Tobacco-Free Kids: www.tobaccofreekids.org

Chest Foundation: www.chestfoundation.org/tobaccoPrevention/index.php

Kaiser Family State Health Facts: www.statehealthfacts.org

Medicare and Medicaid: www.cms.hhs.gov/mcd/viewdecisionmemo. 

asp?id=130 and www.cms.hhs.gov/Smoking Cessation

North American Quitline Consortium (NAQC): www.Naquitline.org

National Cancer Institute: www.nci.nih.gov
Treating Tobacco Use and Dependence: 2008 Update

230

National Guideline Clearinghouse: www.guideline.gov

National Heart, Lung, and Blood Institute: www.nhlbi.nih.gov

National Institute on Drug Abuse: www.nida.nih.gov

Office on Smoking and Health at the Centers for Disease Control and 

Prevention: www.cdc.gov/tobacco

Robert Wood Johnson Foundation: www.rwjf.org

Society for Research on Nicotine and Tobacco: www.srnt.org

TobaccoFree Nurses: www.tobaccofreenurses.org

Tobacco Technical Assistance Consortium: www.ttac.org

University of Wisconsin Center for Tobacco Research and Intervention: 

www.ctri.wisc.edu

World Health Organization: www.who.int

World Health Organization – Tobacco Atlas: www.who.int/tobacco/

statistics/tobacco_atlas/en
231

Appendix C. Coding Information Regarding 

the Diagnosis of and Billing for Tobacco 

Dependence Treatment

Coding for the Treatment of Tobacco Use

Clinicians, clinic administrators, and health care delivery systems require 

appropriate diagnostic and billing codes for the documentation and reimbursement of tobacco dependence treatment. Information on such codes 

may help address a common clinical concern regarding the treatment of 

tobacco-dependent patients: it is difficult to accurately document and 

obtain reimbursement for this treatment. Although examples of such codes 

are provided below, clinicians and billing coders may use other diagnostic and reimbursement codes to document and obtain payment for this 

medical treatment. Additionally, it is incumbent on the clinician to ensure that appropriate billing guidelines are followed and to recognize that 

reimbursement of these codes may vary by payor or benefits package. For 

example, although psychiatric therapeutic codes appropriate for treating 

tobacco dependence exist, some payors or benefits packages have restrictions on mental health benefits. Similarly, reimbursement for preventive 

visits varies greatly among payors and benefits packages.

A systems-based approach will facilitate the understanding and use of 

such codes by clinicians. For example, various clinic or hospital meetings 

(e.g., business sessions, grand rounds, seminars, and coding in-service 

sessions) can explain and highlight the use of tobacco dependence codes 

for diagnosis and reimbursement. Additionally, these diagnostic codes can 

be preprinted on the billing and diagnostic coding sheets as a “check-off ” 

so that clinicians are not required to recall and manually document such 

treatment. Finally, clinicians can be reminded that counseling by itself is a 

reimbursable activity and can be billed-for based on the number of minutes of counseling.

1. Diagnostic Codes (ICD-9-CM)

When clinicians provide treatment to patients dependent on tobacco, the 

following diagnostic codes can be used. They can be found in the ICD-9-

CM (International Classification of Diseases, 9th Revision, Clinical Modification) coding manual under several sections:
Treating Tobacco Use and Dependence: 2008 Update

232

Mental Disorders (290-319) 

305.1 Tobacco Use Disorder (Tobacco Dependence). Cases in which tobacco 

is used to the detriment of a person’s health or social functioning or in 

which there is tobacco dependence. Tobacco dependence is included here 

rather than under drug dependence because tobacco differs from other 

drugs of dependence in its psychotropic effect. This excludes: History of 

tobacco use (V15.82).

V Codes 

V15.82 History of Tobacco Use. This excludes: Tobacco dependence (305.1).

Diseases of Oral Cavity, Salivary Glands, and Jaws 

523.6 Accretions on teeth

Supragingival: Deposits on teeth: tobacco.

Accidental Poisoning by Other Solid and Liquid Substances, Gases, 

and Vapors 

E869.4 Secondhand tobacco smoke.

Complications Mainly Related To Pregnancy 

649.0 Tobacco use disorder complicating pregnancy, childbirth, or the 

puerperium.

2. Billing Codes (Current Procedural Terminology [CPT] Codes)

A number of billing codes may be used for reimbursement of the provision 

of tobacco dependence treatment. The examples provided fall under the 

general categories of preventive medicine services, psychiatric therapeutic 

procedures, and dental codes.

A. Preventive Medicine Services

The following codes are used to report the preventive medicine evaluation 

and management of infants, children, adolescents, and adults.

The “comprehensive” nature of the Preventive Medicine Services codes 

99383–99397 reflects an age- and gender-appropriate history/exam and 

is NOT synonymous with the “comprehensive” examination required in 

Evaluation and Management codes 99201–99350.
Appendixes

233

Codes 99383–99397 include counseling/anticipatory guidance/risk factor 

reduction interventions, which are provided at the time of the initial or 

periodic comprehensive preventive medicine examination. (Refer to codes 

99401–99412 for reporting those counseling/anticipatory guidance/risk 

factor reduction interventions that are provided at an encounter separate 

from the preventive medicine examination.)

A1. Initial or Periodic Comprehensive Preventive Medicine 

Examination

New Patient

99383 Initial comprehensive preventive medicine.

Initial comprehensive preventive medicine evaluation and management of 

an individual, including an age and gender-appropriate history, examination, counseling/anticipatory guidance/risk factor reduction interventions, 

and the ordering of appropriate immunization(s), laboratory/diagnostic 

procedures, new patient; late childhood (age 5 through 11 years).

99384 Adolescent (age 12–17 years).

99385 Adult (age 18–39 years).

99386 Adult (age 40–64 years).

99387 Adult (age 65 years and older).

Established Patient

99393 Periodic comprehensive preventive medicine. 

Reevaluation and management of an individual, including an age- and 

gender-appropriate history, examination, counseling/anticipatory guidance/risk factor reduction interventions, and the ordering of appropriate 

immunization(s), laboratory/diagnostic procedures, established patient; 

late childhood (age 5 through 11 years).

99394 Adolescent (age 12–17 years).
Treating Tobacco Use and Dependence: 2008 Update

234

99395 Adult (age 18–39 years).

99396 Adult (age 40–64 years).

99397 Adult (age 65 years and older).

A2. Counseling and/or Risk Factor Reduction Intervention.

These codes are used to report services provided to individuals at a separate encounter for the purpose of promoting health and preventing illness 

or injury. As such, they are appropriate for the specific treatment of tobacco use and dependence. They are appropriate for initial or followup tobacco dependence treatments (new or established patient). For the specific 

preventive medicine counseling codes, the number of minutes counseled 

determines the level of billing (codes 99400–99404 for 15 to 60 minutes of 

counseling). 

Preventive Medicine, Individual Counseling

99401 Preventive medicine counseling and/or risk factor reduction 

intervention(s) provided to an individual (separate procedure); approximately 15 minutes.

99402 Approximately 30 minutes.

99403 Approximately 45 minutes.

99404 Approximately 60 minutes.

Smoking Cessation Counseling

These codes are for face-to-face counseling by a physician or other qualified health care professional, using “standardized, evidence-based screening instruments and tools with reliable documentation and appropriate 

sensitivity.”

99406 For intermediate visit of between 3 and 10 minutes.

99407 For an intensive visit lasting longer than 30 minutes.
Appendixes

235

Preventive Medicine, Group Counseling

99411 Preventive medicine counseling and/or intervention to treat the risk 

factor of tobacco use provided to an individual (separate procedure); approximately 30 minutes.

99412 Approximately 60 minutes.

B. Psychiatric Therapeutic Procedures/Codes for Billing 

The psychiatric therapeutic procedure billing codes are typically used for 

insight-oriented, behavior modifying, and/or supported psychotherapy. 

This refers to the development of insight of affective understanding, the use 

of behavior modification techniques, the use of supportive interactions, the 

use of cognitive discussion of reality, or any combination of the above to 

provide therapeutic change. All of the counseling interventions for tobacco 

dependence demonstrated to be effective in this Guideline fall under these 

headings.

It should be noted that these billing codes can be modified for those patients receiving only counseling (psychotherapy) and for others that receive 

counseling (psychotherapy), medical evaluation, and management services. 

These evaluation and management services involve a variety of responsibilities unique to the medical management of psychiatric patients, such as 

medical diagnostic evaluation (e.g., evaluation of comorbid medical conditions, drug interactions, and physical examinations); drug management 

when indicated; physician orders; and interpretation of laboratory or other 

medical diagnostic studies and observations. Thus, the use of a psychiatric 

therapeutic billing code with medical evaluation and management services 

would be appropriate for the clinician who provides both of the key tobacco dependence interventions documented as effective in the Guideline: 

counseling and medications. 

In documenting treatment for tobacco dependence using the psychiatric 

therapeutic procedure codes, the appropriate code is chosen on the basis 

of the type of psychotherapy (e.g., insight-oriented, behavior modifying, 

and/or supportive using verbal techniques); the place of service (office vs. 

inpatient); the face-to-face time spent with the patient during the treatment (both for psychotherapy and medication management); and whether 

evaluation and management services are furnished on the same date of 

service as psychotherapy.
Treating Tobacco Use and Dependence: 2008 Update

236

B1. Office or Other Outpatient Facility

Insight-oriented, behavior modifying, and/or supportive psychotherapy.

90804 Individual psychotherapy, insight oriented, behavior modifying and/

or supportive, in an office or outpatient facility, approximately 20 to 30 

minutes face-to-face with the patient.

90805 With medical evaluation and management services.

90806 Individual psychotherapy, insight-oriented, behavior modifying, 

and/or supportive, in an office or outpatient facility, approximately 45 to 50 

minutes face-to-face with the patient.

90807 With medical evaluation and management services.

90808 Individual psychotherapy, insight-oriented, behavior modifying, 

and/or supportive, in an office or outpatient facility, approximately 75 to 80 

minutes face-to-face with the patient.

90809 With medical evaluation and management services.

B2. Inpatient Hospital, Partial Hospital, or Residential Care Facility

Insight-oriented, behavior modifying, and/or supportive psychotherapy.

90816 Individual psychotherapy, insight-oriented, behavior modifying, 

and/or supportive, in an inpatient hospital, partial hospital, or residential 

care setting, approximately 20 to 30 minutes face-to-face with the patient.

90817 With medical evaluation and management services.

90818 Individual psychotherapy, insight-oriented, behavior modifying, 

and/or supportive, in an inpatient hospital, partial hospital or residential 

care setting, approximately 45 to 50 minutes face-to-face with the patient.

90819 With medical evaluation and management services.

90821 Individual psychotherapy, insight-oriented, behavior modifying, 

and/or supportive, in an inpatient hospital, partial hospital or residential 

care setting, approximately 75 to 80 minutes face-to-face with the patient.
Appendixes

237

90822 With medical evaluation and management services.

B3. Other Psychotherapy

90853 Group psychotherapy (other than a multiple-family group).

C. Dental Code –CDT Codes

D1320 Tobacco counseling for the control and prevention of oral disease.

Please Note: The following section is included 

for informational purposes only.

The National Center for Health Statistics (NCHS), the Federal agency 

responsible for use of the International Statistical Classification of Diseases 

and Related Health Problems, 10th revision (ICD-10) in the United States, 

has developed a clinical modification of the classification for morbidity 

purposes. The ICD-10 is used to code and classify mortality data from 

death certificates, having replaced ICD-9 for this purpose as of January 1, 

1999. ICD-10-CM is planned as the replacement for ICD-9-CM, volumes 1 

and 2.

An updated July 2007 release of ICD-10-CM is available for public viewing. However, at the time of this printing, the codes in ICD-10-CM are 

not currently valid for any purpose or use other than mortality coding. Once implemented, this information must be validated as current 

before use.

F17 Nicotine dependence 

Excludes1: history of tobacco dependence (Z87.82) tobacco use NOS 

(Z72.0) Excludes2: tobacco use (smoking) during pregnancy, childbirth, 

and the puerperium (O99.33-) toxic effect of nicotine (T65.2-).

F17.2 Nicotine dependence 

F17.20 Nicotine dependence, unspecified 

F17.200 Nicotine dependence, unspecified, uncomplicated 

F17.201 Nicotine dependence, unspecified, in remission 

F17.203 Nicotine dependence, unspecified, with withdrawal 

nicotine-induced disorders 

F17.209 Nicotine dependence, unspecified, with unspecified 

nicotine-induced disorders 
Treating Tobacco Use and Dependence: 2008 Update

238

F17.21 Nicotine dependence, cigarettes 

F17.210 Nicotine dependence, cigarettes, uncomplicated 

F17.211 Nicotine dependence, cigarettes, in remission 

F17.213 Nicotine dependence, cigarettes, with withdrawal 

F17.218 Nicotine dependence, cigarettes, with other 

nicotine-induced disorders 

F17.219 Nicotine dependence, cigarettes, with unspecified 

nicotine-induced disorders 

F17.22 Nicotine dependence, chewing tobacco 

F17.220 Nicotine dependence, chewing tobacco, uncomplicated 

F17.221 Nicotine dependence, chewing tobacco, in remission

F17.223 Nicotine dependence, chewing tobacco, with withdrawal 

F17.228 Nicotine dependence, chewing tobacco, with other 

nicotine-induced disorders 

F17.229 Nicotine dependence, chewing tobacco, with 

unspecified nicotine-induced disorders 

F17.29 Nicotine dependence, other tobacco product 

F17.290 Nicotine dependence, other tobacco product, 

uncomplicated 

F17.291 Nicotine dependence, other tobacco product, in 

remission 

F17.293 Nicotine dependence, other tobacco product, 

withwithdrawal 

F17.298 Nicotine dependence, other tobacco product, with 

other nicotine-induced disorders 

F17.299 Nicotine dependence, other tobacco product, with 

unspecified nicotine-induced disorders

O99.3 Mental disorders and diseases of the nervous system complicating pregnancy, childbirth, and the puerperium

O99.33 Smoking (tobacco) complicating pregnancy, childbirth, 

and the puerperium 

Use additional code from F17 to identify type of tobacco. 

O99.330 Smoking (tobacco) complicating pregnancy, 

unspecified trimester 

O99.331 Smoking (tobacco) complicating pregnancy, first 

trimester 
Appendixes

239

O99.332 Smoking (tobacco) complicating pregnancy, second 

trimester 

O99.333 Smoking (tobacco) complicating pregnancy, third 

trimester 

O99.334 Smoking (tobacco) complicating childbirth 

O99.335 Smoking (tobacco) complicating the puerperium

T65 Toxic effect of other and unspecified substances

T65.2 Toxic effect of tobacco and nicotine 

Excludes2: nicotine dependence (F17.-).

T65.21 Toxic effect of chewing tobacco 

T65.211 Toxic effect of chewing tobacco, accidental 

(unintentional)

Toxic effect of chewing tobacco NOS 

T65.212 Toxic effect of chewing tobacco, intentional self-harm 

T65.213 Toxic effect of chewing tobacco, assault 

T65.214 Toxic effect of chewing tobacco, undetermined 

T65.22 Toxic effect of tobacco cigarettes 

Toxic effect of tobacco smoke 

Use additional code for exposure to secondhand 

tobacco smoke (Z57.31, Z58.7). 

T65.221 Toxic effect of tobacco cigarettes, accidental 

(unintentional)

Toxic effect of tobacco cigarettes NOS 

T65.222 Toxic effect of tobacco cigarettes, intentional self-harm 

T65.223 Toxic effect of tobacco cigarettes, assault 

T65.224 Toxic effect of tobacco cigarettes, undetermined 

T65.29 Toxic effect of other tobacco and nicotine 

T65.291 Toxic effect of other tobacco and nicotine, accidental 

(unintentional)

Toxic effect of other tobacco and nicotine NOS 

T65.292 Toxic effect of other tobacco and nicotine, intentional 

self-harm 

T65.293 Toxic effect of other tobacco and nicotine, assault 

T65.294 Toxic effect of other tobacco and nicotine, undetermined
Treating Tobacco Use and Dependence: 2008 Update

240

Z71 Persons encountering health services for other counseling and 

medical advice, not elsewhere classified

Z71.6 Tobacco abuse counseling

Use additional code for nicotine dependence (F17.-).

Z72 Problems related to lifestyle

Z72.0 Tobacco use

Tobacco use NOS 

 Excludes1: history of tobacco dependence

(Z87.82), nicotine dependence (F17.2-), tobacco

dependence (F17.2-), tobacco use during 

pregnancy (O99.33-).

Z87 Personal history of other diseases and conditions

Z87.8 Personal history of other specified conditions 

Z87.82 Personal history of nicotine dependence

 Excludes1: current nicotine dependence

(F17.2-).
241

Appendix D. Key Recommendation Changes 

From the 2000 PHS-Sponsored Clinical 

Practice Guideline: Treating Tobacco Use 

and Dependence

Below is a summary of the substantive changes in recommendations from 

the 2000 Guideline to the 2008 Guideline Update. These changes include 

new 2008 update recommendations as well as recommendations that were 

deleted or changed substantially from the 2000 Guideline.

NEW RECOMMENDATIONS IN THE 2008 UPDATE

Most, but not all, of the new recommendations appearing in the 2008 

Treating Tobacco Use and Dependence Update resulted from new metaanalyses of the topics chosen by the Guideline Panel.

1. Formats of Psychosocial Treatments

Recommendation: Tailored materials, both print and Web-based, appear 

to be effective in helping people quit. Therefore, clinicians may choose 

to provide tailored self-help materials to their patients who want to quit. 

(Strength of Evidence = B)

2. Combining Counseling and Medication

Recommendation: The combination of counseling and medication is more 

effective for smoking cessation than either medication or counseling alone. 

Therefore, whenever feasible and appropriate, both counseling and medication should be provided to patients trying to quit smoking. (Strength of 

Evidence = A)

Recommendation: There is a strong relation between the number of sessions of counseling when it is combined with medication, and the likelihood of successful smoking abstinence. Therefore, to the extent possible, 

clinicians should provide multiple counseling sessions, in addition to 

medication, to their patients who are trying to quit smoking. (Strength of 

Evidence = A)
Treating Tobacco Use and Dependence: 2008 Update

242

3. For Smokers Not Willing To Make a Quit Attempt at This Time

Recommendation: Motivational intervention techniques appear to be effective in increasing a patient’s likelihood of making a future quit attempt. 

Therefore, clinicians should use motivational techniques to encourage 

smokers who currently are not willing to quit to consider making a quit 

attempt in the future. (Strength of Evidence = B)

4. Nicotine Lozenge

Recommendation: The nicotine lozenge is an effective smoking cessation 

treatment that patients should be encouraged to use. (Strength of Evidence 

= B)

5. Varenicline

Recommendation: Varenicline is an effective smoking cessation treatment 

that patients should be encouraged to use. (Strength of Evidence = A)

6. Specific Populations

Recommendation: The interventions found to be effective in this Guideline have been shown to be effective in a variety of populations. In addition, many of the studies supporting these interventions comprised diverse 

samples of tobacco users. Therefore, interventions identified as effective in 

this Guideline are recommended for all individuals who use tobacco, except when medically contraindicated or with specific populations in which 

medication has not been shown to be effective (pregnant women, smokeless tobacco users, light smokers, and adolescents). (Strength of Evidence = 

B)

7. Light Smokers

Recommendation: Light smokers should be identified, strongly urged to 

quit, and provided counseling cessation interventions. (Strength of Evidence = B)
Appendixes

243

RECOMMENDATIONS FROM THE 2000 GUIDELINE THAT 

WERE DELETED FROM THE 2008 UPDATE

All “C” level recommendations were reconsidered by the Panel, with the 

goal of limiting those that are based, in part, on Panel opinion. The 2008 

Guideline Update has 8 “C” recommendations; the 2000 Guideline had 

18. There were additional deletions of recommendations from the 2000 

Guideline. Some of these other deletions reflect addressing specific populations differently in the 2008 Guideline update.

1. Advice To Quit Smoking

Recommendation: All clinicians should strongly advise their patients who 

use tobacco to quit. Although studies independently have not addressed 

the impact of advice to quit by all types of nonphysician clinicians, it is reasonable to believe that such advice is effective in increasing their patients’ 

long-term quit rates. (Strength of Evidence = B)

2. Types of Counseling and Behavioral Therapies

Recommendation: Aversive smoking interventions (rapid smoking, rapid 

puffing, other aversive smoking techniques) increase abstinence rates and 

may be used with smokers who desire such treatment or who have been 

unsuccessful using other interventions. (Strength of Evidence = B)

3. Medications

Recommendation: Long-term smoking cessation medications should be 

considered as a strategy to reduce the likelihood of relapse. (Strength of 

Evidence = C)

4. Gender

Recommendation: The same smoking cessation treatments are effective 

for both men and women. Therefore, except in the case of the pregnant 

smoker, the same interventions can be used with both men and women. 

(Strength of Evidence = B)

5. Pregnancy

Recommendation: Medications should be considered when a pregnant 

woman otherwise is unable to quit, and when the likelihood of quitting, 
Treating Tobacco Use and Dependence: 2008 Update

244

with its potential benefits, outweighs the risks of the medications and potential continued smoking. (Strength of Evidence = C)

6. Racial and Ethnic Minority Populations

Recommendation: Smoking cessation treatments have been shown to be 

effective across different racial and ethnic minorities. Therefore, members 

of racial and ethnic minorities should be provided treatments shown to be 

effective in this Guideline. (Strength of Evidence = A)

Recommendation: Whenever possible, tobacco dependence treatments 

should be modified or tailored to be appropriate for the ethnic or racial 

populations with which they are used. (Strength of Evidence = C)

7. Hospitalized Smokers

Recommendation: Smoking cessation treatments have been shown to be 

effective for hospitalized patients. Therefore, hospitalized patients should 

be provided smoking cessation treatments shown to be effective in this 

Guideline. (Strength of Evidence = B)

8. Psychiatric Illness and/or Nontobacco Chemical Dependency

Recommendation: Smokers with comorbid psychiatric conditions should 

be provided smoking cessation treatments identified as effective in this 

Guideline. (Strength of Evidence = C)

Recommendation: Bupropion SR and nortriptyline, efficacious treatments for smoking cessation in the general population, also are effective in 

treating depression. Therefore, bupropion SR and nortriptyline especially 

should be considered for the treatment of tobacco dependence in smokers 

with current or past history of depression. (Strength of Evidence = C)

Recommendation: Evidence indicates that smoking cessation interventions do not interfere with recovery from chemical dependency. Therefore, 

smokers receiving treatment for chemical dependency should be provided 

smoking cessation treatments shown to be effective in this Guideline, including both counseling and medications. (Strength of Evidence = C)
Appendixes

245

9. Children and Adolescents

Recommendation: When treating adolescents, clinicians may consider 

prescriptions for bupropion SR or NRT when there is evidence of nicotine 

dependence and desire to quit tobacco use. (Strength of Evidence = C) 

10. Older Smokers

Recommendation: Smoking cessation treatments have been shown to be 

effective for older adults. Therefore, older smokers should be provided 

smoking cessation treatments shown to be effective in this Guideline. 

(Strength of Evidence = A)

11. Weight Gain After Stopping Smoking

Recommendation: The clinician should acknowledge that quitting smoking is often followed by weight gain. Additionally, the clinician should: 

(1) note that the health risks of weight gain are small when compared to 

the risks of continued smoking; (2) recommend physical activities and a 

healthy diet to control weight; and (3) recommend that patients concentrate primarily on smoking cessation, not weight control, until exsmokers 

are confident that they will not return to smoking. (Strength of Evidence = C)

12. Cost-Effectiveness of Tobacco Interventions

Recommendation: Intensive smoking cessation interventions are especially efficacious and cost-effective, and smokers should have ready access 

to these services as well as to less intensive interventions. (Strength of 

Evidence = B)

Note: The tobacco dependence treatments shown to be effective in this 

Guideline still are recommended as highly cost-effective with Strength of 

Evidence = A. The above recommendation, number 12, was deleted because it refers only to “intensive” smoking cessation interventions.
Treating Tobacco Use and Dependence: 2008 Update

246

RECOMMENDATIONS FROM THE 2000 GUIDELINE THAT 

WERE SUBSTANTIALLY CHANGED IN THE 2008 UPDATE:

The results of meta-analyses or consideration of literature not available for 

the 2000 Guideline led to substantive changes in some of the 2000 Guideline recommendations. Minor changes in wording are not listed here.

1. Screening and Assessment

2000 Guideline. Recommendation #1: All patients should be asked if they 

use tobacco and should have their tobacco-use status documented on a 

regular basis. Evidence has shown that this significantly increases rates of 

clinician intervention. (Strength of Evidence = A)

2000 Guideline. Recommendation #2: Clinic screening systems, such as 

expanding the vital signs to include tobacco use status, or the use of other 

reminder systems, such as chart stickers or computer prompts, are essential for the consistent assessment, documentation, and intervention with 

tobacco use. (Strength of Evidence = B)

2008 Guideline Update. Recommendation: All patients should be asked if 

they use tobacco and should have their tobacco use status documented on 

a regular basis. Evidence has shown that clinic screening systems, such as 

expanding the vital signs to include tobacco use status, or the use of other 

reminder systems, such as chart stickers or computer prompts, significantly 

increase rates of clinician intervention. (Strength of Evidence = A)

2. Types of Counseling and Behavioral Therapies

2000 Guideline. Recommendation: Three types of counseling and behavioral therapies result in higher abstinence rates: (1) providing smokers 

with practical counseling (problemsolving skills/skills training); (2) providing social support as part of treatment; and (3) helping smokers obtain 

social support outside the treatment environment. These types of counseling and behavioral therapies should be included in smoking cessation 

interventions. (Strength of Evidence = B)

2008 Guideline Update. Recommendation: Two types of counseling and 

behavioral therapies result in higher abstinence rates: (1) providing smokers with practical counseling (problemsolving skills/skills training); and 
Appendixes

247

(2) providing support and encouragement as part of treatment. These types 

of counseling elements should be included in smoking cessation interventions. (Strength of Evidence = B)

3. Medications 

2000 Guideline. Recommendation: All patients attempting to quit should 

be encouraged to use effective medications for smoking cessation, except in 

the presence of special circumstances. (Strength of Evidence = A)

2008 Guideline Update. Recommendation: Clinicians should encourage all 

patients attempting to quit to use effective medications for tobacco dependence treatment, except where contraindicated or for specific populations 

for which there is insufficient evidence of effectiveness (i.e., pregnant women, smokeless tobacco users, light smokers, and adolescents). (Strength of 

Evidence = A)

4. Combination Medications

2000 Guideline. Recommendation: Combining the nicotine patch with a 

self-administered form of nicotine replacement therapy (either the nicotine 

gum or nicotine nasal spray) is more efficacious than a single form of nicotine replacement, and patients should be encouraged to use such combined 

treatments if they are unable to quit using a single type of first-line medication. (Strength of Evidence = B)

2008 Guideline Update. Recommendation: Certain combinations of firstline medications have been shown to be effective smoking cessation treatments. Therefore, clinicians should consider using these combinations of 

medications with their patients who are willing to quit. Effective combination medications are long-term (> 14 weeks) nicotine patch + other NRT 

(gum and spray), the nicotine patch + the nicotine inhaler, and the nicotine patch + bupropion SR. (Strength of Evidence = A)

5. Children and Adolescents

2000 Guideline. Recommendation #1: Counseling and behavioral interventions shown to be effective with adults should be considered for use 

with children and adolescents. The content of these interventions should be 

modified to be developmentally appropriate. (Strength of Evidence = C)
Treating Tobacco Use and Dependence: 2008 Update

248

2008 Guideline Update. Recommendation #1: Counseling has been shown 

to be effective in treatment of adolescent smokers. Therefore, adolescent 

smokers should be provided with counseling interventions to aid them in 

quitting smoking. (Strength of Evidence = B)

2000 Guideline. Recommendation #2: Clinicians in a pediatric setting 

should offer smoking cessation advice and interventions to parents to limit 

children’s exposure to secondhand smoke. (Strength of Evidence = B)

2008 Guideline Update. Recommendation #2: Secondhand smoke is 

harmful to children. Cessation counseling delivered in pediatric settings 

has been shown to be effective in increasing cessation among parents who 

smoke. Therefore, to protect children from secondhand smoke, clinicians 

should ask parents about tobacco use and offer them cessation advice and 

assistance. (Strength of Evidence = B)

6. Noncigarette Tobacco Users

2000 Guideline. Recommendation: Smokeless/spit tobacco users should be 

identified, strongly urged to quit, and treated with the same counseling cessation interventions recommended for smokers. (Strength of Evidence = B)

2008 Guideline Update. Recommendation: Smokeless tobacco users should 

be identified, strongly urged to quit, and provided counseling cessation 

interventions. (Strength of Evidence = A)

7. Cost-Effectiveness of Tobacco Dependence Interventions

2000 Guideline. Recommendation: Sufficient resources should be allocated 

for clinician reimbursement and systems support to ensure the delivery of 

efficacious tobacco use treatments. (Strength of Evidence = C)

2008 Guideline Update. Recommendation: Sufficient resources should be 

allocated for systems support to ensure the delivery of effective tobacco use 

treatments. (Strength of Evidence = C)

8. Tobacco Dependence Treatment as a Part of Assessing Health 

Care Quality

2000 Guideline. Recommendation: Provision of Guideline-based interventions to treat tobacco use and addiction should be included in standard 
Appendixes

249

ratings and measures of overall health care quality (e.g., NCQA HEDIS, the 

Foundation for Accountability [FACCT]). (Strength of Evidence = C)

2008 Guideline Update. Recommendation: Provision of Guideline-based 

interventions to treat tobacco use and dependence should remain in standard 

ratings and measures of overall health care quality (e.g., NCQA, HEDIS). 

These standard measures also should include measures of outcomes (e.g., 

use of cessation treatment, short- and long-term abstinence rates) that 

result from providing tobacco dependence interventions. (Strength of 

Evidence = C)

9. Providing Smoking Cessation Treatments as a Covered Benefit

2000 Guideline. Recommendation: Smoking cessation treatments (both 

medication and counseling) should be included as a paid or covered benefit 

by health benefit plans, because doing so improves utilization and overall 

abstinence rates. (Strength of Evidence = B)

2008 Guideline Update. Recommendation: Providing tobacco dependence 

treatments (both medication and counseling) as a paid or covered benefit 

by health insurance plans has been shown to increase the proportion of 

smokers who use cessation treatment, attempt to quit, and successfully 

quit. Therefore, treatments shown to be effective in the Guideline should 

be included as covered services in public and private health benefit plans. 

(Strength of Evidence = A) 

251

A

Abstinence 

continuous, 24

intervention assessment, 94-96

percentages, 27-28

permanent, 15

self-reported, 23

statistics, 21

sustained, 44

telephone counseling, 28

tobacco dependence and, 6 

Abstinence rate

acupuncture, 100

clinical intervention intensity, 83-86

clinical type, 87-88

clinician training, 130

counseling, 96-101

covered health insurance benefit, 140

feedback, 105

medication and counseling, 102, 103

medication effectiveness, 121, 122

medications, 109

nicotine patch, 129

NRT therapy, 124

quit advice, 83

quitline counseling, 92

tobacco user identification, 79

variables, 81

various formats, 90-91

Acupuncture, 99

Acute myocardial infarction, 2

Adolescent smoker, 6, 11, 33, 157-159

assisting, 42

counseling, 3, 35, 159-161

intervention studies, 21

medications, 161

weight gain, 173-174

Advice, 41

Alcohol consumption, 42, 104

All-comers, 21, 26, 29

American Health Insurance Plans, 137

Amphetamines, 13

Antiarrhythmics, type 1C, 116

Antipsychotics, 116

Anxiolytics, 125

Assessment, 41

specialized, 79-81

Assistance, 42-43

Asthma, 152-153

Aversive smoking, 76, 96, 97

B

Behavioral therapies, 96-101

Benzodiazepine, 115, 125

Beta-blockers, 115, 116, 125

Bidis, 164

Biochemical confirmation, 23

Biological marker, 105

Birth weight. See Infant, low birth weight

Bisexual smokers. See Lesbian/gay/bisexual

 transgender smokers

Bupropion SR, 7, 42, 44, 45 

clinical use of, 46-47

coding rules, 108

drug interactions, 116

effectiveness of, 110

intensive interventions, 66

Buspirone, 125

C

Caffeine, 115

Cancer, 11, 152-153

Carbamazepine, 116

Cardiovascular disease, 46, 152-153

bupropion SR, 46

nicotine gum, 48

nicotine inhaler, 49

nicotine lozenge, 50

nicotine nasal spray, 51

nicotine patch, 52

nortriptyline, 56

NRT in, 127

varencicline, 53

Centers for Disease Control and Prevention, 19

Challenges, 42

Child smokers, 6, 33, 157-159, 161

counseling, 3, 159-161

medications, 161

Chronic disease model, 6, 15-16

Chronic obstructive pulmonary disease

 (COPD), 11, 152-153

Cimetidine, 116

Clean indoor air laws, 16

Clinical intervention, 5, 32, 35, 37-40, 83-86 

intensity, 83-86

tobacco user identification, 78

Clinical practice guideline, 16

prescribing, 44-46

Clinician 

training, 130-134

type, 87-88

Index
252

Clonidine, 42, 45 

clinical use of, 55

recommendations, 116-117

Clozapine, 115

Cocaine, 13

Cochrane analysis, 126, 144

Cochrane review, 126

Cognitive behavioral therapy. See Behavioral

 therapy

Combination medication. See Medication: 

combination

Community programs, 19

Comorbidities, smokers with, 6, 33, 148,

 152-153

effective treatments for, 145

Computerized interventions, 93-94

Confidence intervals, 27

Confounders, 25

Congestive heart failure, 2. See also

 Cardiovascular disease

Contact time, 85

Controlled trials, 17, 21, 74, 79

Coordination of care, 16

Cost-effectiveness, of intervention, 134-138

Cost per quality-adjusted-life-year saved, 135

Counseling, 7, 8, 33, 88-101

children, adolescents, 159-161

group. See Group counseling

individual. See Individual counseling

light smokers, 162-163

medication and, 101-103

parents, 160-161

prevalence of, 35-36

quitline, 29

strategies, 3, 6

studies, 17

types of, 96-101

Culture, 148

Cyclophosphamide, 116

D

Data tables, 28-29

Delivery mode, 89-91

Demographics, 1-2

Dependency, nicotine nasal spray, 51

Depression, 45, 114, 127, 146, 154-56

Diabetes, 152-153

Diazepam, 125

Disability, 59

Discrepancy, 57, 58

Disease model, 15

Dose-response relationship, 83-86

Drug interactions, 115-116

Duration, of treatment, 56

E

Education, 69, 71

Effectiveness, 29. See also specific forms

Efficacy, 29

EGRET Logistic Normal Model, 25

Empathy, 57, 58

Environmental tobacco smoke, 11, 157,

 160-161

Ethnic minority smoker. See Minority 

 smokers

Evidence, 32, 73-74, 76-77 

strength of, 77

screening , 77-79

tables preparation, 22

Evidence-based treatment, 9-10

findings, 16

recommendations, 13-14

Exercise, 175

Extratreatment social support, 76, 96, 97

F

Feedback, 69, 71, 105

First-line medication. See Medication: 

 first-line

Fluuoxetine, 115

Followup, 132

arranging, 39 

assessment, 94-96

contact, arranging, 43

duration, 23

Food and Drug Administration (FDA), 2, 9

G

Gay smokers. See Lesbian/gay/bisexual/

 transgender smokers

Gender, 156, 157

Group counseling, 88-92. See also Counseling

 Guide to Community Preventive Services, 19

Guideline 

caveats, 30-31

development, methodology, 16-17, 19, 20

evidence selection, 19, 21

evolution, 3-4

external review of, 31

organization of update, 32-33

style and structure, 4-6

topics included, 17-19

H

Harm reduction, 155, 157, 160, 161

Hazardous activities

clonidine, 55

nortriptyline, 56

Health benefits, 61-62, 123, 137, 168
253

Health care systems

administrators recommendations, 69-70

costs, 136

policies, 9, 69, 72

quality, 138

Health insurance 

coverage, 70, 72, 139-141

recommendations, 69-70

Health threat, 1

Heart disease, 11

HEDIS, 35, 71, 138

Helpline. See Telephone quitline

HIV-positive smokers, 6, 33, 148-149

effective treatments for, 144

risk behaviors of, 104

Hospital policies. See Health care: policies

Hospitalized smokers, 6, 33, 149-150

effective treatments for, 144-145

Hotline. See Telephone quitline

Hypnosis, 100

I

Identifying smokers. See Tobacco user 

 identification

Individual counseling, 88, 92. See also

 Counseling

Infant, low birth weight, 26-27

Institutionalization, 16

Insulin, 115

Insurance coverage. See Health insurance:

 coverage

Intensive intervention, 5, 32, 63-66

components of, 65-66

relevant findings, 65

Intent-to-treat analysis, 23-24

Intervention

community-level, 19

computerized, 93-94 

consistency, 1, 11-12

children, adolescent, young adult, 3

clinical. See Clinical intervention

coordinated, 16

effective, 1, 12, 30-31

intensive. See Intensive intervention

need for, 13

patient recently quit, 61

problems encountered by former 

 smokers, 61-62

psychosocial. See Psychosocial 

 intervention

stepped-care, 92

systems. See Systems intervention

tailored. See Tailored intervention

Involuntary exposure, 11, 157, 160-161

J-K

Joint Commission, 2

Kidney disease, 53

L

Language, 148

Lapses, 62

Lesbian/gay/bisexual/transgender (LGBT)

 smokers, 6, 33, 151

effective treatments for, 145

Light smokers, 33, 162-163

assistance, 42

medications and, 45

Limited educational attainment, 6

Limited formal education smokers, 6, 33,

 151-152

effective treatments for, 145

Literature review, inclusion, 21-22

Local irritation, nicotine inhaler, 49

Logistic regression, 24

Low socio-economic status smokers. See

 socio-economic status, low

M

Managed care plans, 2

MAO inhibitors, 116, 127

Maternal smoking, low birth weight, 26-27

Mecamylamine, 126

Medicaid, 137

Medical comorbidities. See Comorbidities, 

smokers with

Medical expenses, 11

Medicare, 2

Medication, 7-8, 9 

adherence, 46

for children, adolescents, 161

combination, 46, 118

combination effectiveness, 120

counseling and, 101-103

effectiveness, 31, 169-170

evidence, 33, 106-108

extended use of, 126

first-line, 108-109, 115-116. See also

 specific medications

for light smokers, 162-163

long-term use of, 46

for noncigarette tobacco users, 164

not recommended, 124-126

over-the-counter, 128-129

relative effectiveness of, 120-122

safety, 170-173

second-line, 116

use of, 12
254

Meta-analyses, 17, 21

adolescent counseling, 159

clinician training, 130, 131, 132

clinician types, 88

contact time, 85

counseling types, 97

covered health insurance benefit, 140

data tables, 28-29

intent-to-treat data, 23-24

interpretation of results, 26-28

intervention intensity levels, 84

limitations of, 26

medication abstinence rates, 109

medication and counseling, 102, 103

medication effectiveness, 121, 122

nicotine patch, 129

NRT therapy, 124

person-to-person treatment, 86

problemsolving skills, 98-99

psychosocial interventions, 166

quitline counseling, 92

self-help intervention, 169

techniques, 24-26

tobacco user identification, 78, 79

update topics, 74-75, 75-76

various formats, 90-91

Methodology, 5

Minority smokers, 2, 6, 33, 155-156

effective treatments for, 147

Motivation, 5 R’s, 59-60

Motivational interviewing, 57, 58, 100,

 104-106

Motivational treatments, 8

Multiple clinicians, 87

N

Naltrexone, 121, 125

Nasal/airway reactions, nicotine nasal 

 spray, 51

National Committee for Quality Assurance,

 2, 35

Negative affect, 76, 97, 98

Nicotine gum, 7, 42, 44, 45 

clinical use of, 47-48

coding rules for, 108

effectiveness of, 110-111

intensive interventions with, 66

Nicotine inhaler, 7, 42, 44, 45 

clinical use of, 49

coding rules for, 108

effectiveness of, 111

intensive interventions with, 66

Nicotine lozenge, 7, 42, 44, 45

clinical use of, 50

effectiveness of, 111-112

intensive interventions with, 66

Nicotine nasal spray, 7, 42, 44, 45 

clinical use of, 51 

coding rules for, 108

effectiveness of, 112

intensive interventions with, 66

Nicotine patch, 8, 31, 42, 44, 45 

clinical use of, 52-53

coding rules for, 108

effectiveness of, 112-113

intensive interventions with, 66

over-the-counter, 128-129

Nicotine patch/antidepressant 

 combination, 119

Nicotine patch/bupropion SR 

 combination, 118

Nicotine patch/nicotine inhaler 

 combination, 119

Nicotine patch/nicotine replacement therapy

 combination, 119

Nicotine patch/nortriptyline 

 combination, 119

Nicotine replacement therapy, 44, 45

for cardiovascular patients, 127

effectiveness of, 110-113

precessation use of, 122-124

Noncigarette tobacco users, 6, 14, 33, 163-165

assistance, 42

Nonrandomized trials, 30

Nortriptyline, 42, 45 

clinical use of, 56

recommendations, 117-118

O

Odds ratios, 21, 27-28

Olanzapine, 115

Older smokers, 6, 33, 153

effective treatments for, 146

Opiates, 13

Opioid analgesia, 115

Opioid antagonists, 125

Oral mucosa, 48

Orphenadrine, 116

Outcome data, 23-24, 29

Over-the-counter medications, 76, 128

P

Parental counseling. See Counseling: parents

Paroxetine, 119

Person-to-person treatment, 83-86

Phenobarbital, 116

Phenytoin, 116

Physician advice, 82-83
255

Physiological feedback, 105

Placebo, 17, 128-129, 146, 161, 163, 169-171

Pneumonia, 2

Point prevalence, 24, 29

Pregnancy

bupropion SR and, 46

clonidine and, 55

complications in, 11

nicotine gum and, 47

nicotine inhaler and, 49

nicotine lozenge and, 50

nicotine nasal spray and, 51

nicotine patch and, 52

nortriptyline and, 56

varencicline and, 53

Pregnant smokers, 6, 165-173

assisting, 6

clinical practice suggestions for, 167-168

counseling, 35

effective interventions for, 167

medical costs of, 137

medication effectiveness, 169-170

medication safety, 170-173

psychosocial interventions, 165-169

Preventing Tobacco Use Among Young People, 18

Primary care, 38, 85, 106, 155

Problemsolving skills, 98-99

Productivity, 11

Propranolol, 125

Psychiatric disorders, 66, 33, 153-155

effective treatments for, 146-147

Psychiatric reactions, 54

Psychosocial intervention, 165-169

evidence, 33

treatment, 88-101

Purchasers, recommendations, 69-70

Q

Quit advice, 82-83

Quit attempt, 3, 6, 7

assessment, 95

assistance, 39

clinical approaches, 32

as covered health insurance benefit, 140

five A’s model for willing, 40-43

medication evidence, 106-108

motivating to, 32

motivational interviewing, 104-106

permanent abstinence and, 15

precessation use of NRT, 122-123

recent, 38

statistics, 15

strategy for recent quitter, 60-62

unaided, 9-10, 19

unwilling, 8, 38, 57-60

unwilling and precessation NRT, 123-124

willing, 38

willingness assessment, 79-80

Quit date, 132

followup duration, 23

setting, 42

Quit experience, past, 42

Quitline. See Telephone quitline

Quit rates, 8

R

Racial minority smoker. See Minority smoker

Random effects modeling, 24-25

Randomized controlled trials, 17, 19, 21

Rebound hypertension, clonidine, 55

Recommendations, 32

Reducing Tobacco Use, 18

Reference group, 28, 78-79, 83-85, 121

References, 33

Relapse, 10, 15, 24, 32

assessment, 94-96

prevention, 145, 150, 169, 172-173

risk factors, 81

Relevance, 59

Remission, 15

Repetition, 60

Resistance, 57, 58

Resources, 69, 71

Restricted Environmental Stimulation 

Therapy, 100

Return on investment, 136-137

Rewards, 59

Risks, 59

Roadblocks, 60

S

Screening, 36

Secondhand smoke, 157, 160-161

Selective serotonin re-uptake inhibitors 

 (SSRIs), 124, 125

Self-efficacy, 57, 58

Self-help interventions, 89-90

Sertraline, 125

Session length, 84

Session number, 85-86

Side effects

bupropion SR, 47

clonidine, 55

nicotine gum, 48

nicotine lozenge, 50

nicotine patch, 52

nortriptyline, 56

varencicline, 54
256

Silver acetate, 125-126

Skills training, 7, 65-66, 96-99

Skin reactions, nicotine patch, 52

Smokefree policies, 101

Smokeless tobacco. See Noncigarette 

 tobacco use

Smoker identification. See Tobacco user

 identification

Smoking 

cessation, 2. See also Tobacco cessation

perspective, 1-2

Smoking Cessation Clinical Practice Guideline

 (1996), 1, 12-13

Smoking-related disease, 1

Social economic status smokers, low, 6-7, 33,

 151-152

effective treatments for, 145

Social support, 7, 43, 65-66, 76, 96-98, 

 149, 168

Specialized assessment, research, 81-82

Specific populations, 6, 33, 143. See also

 specific types

clinical issues for, 148

effective treatments for, 143-147

Staff performance evaluations, 69, 71

State of Health Care Quality Report, 35

Stepped-care interventions, 92

Strength-of-evidence rating, 29-30

Stroke, 11

Substance use disorders, 6, 33, 104, 153-155

effective treatments for, 146-147

Supplementary materials, 43

Surgeon General reports, 18-19

Systems evidence, 33, 130-134

Systems interventions, 5, 32, 67-72

T

Tailored intervention, 80, 93, 149, 151, 

 153, 155

Telephone quitline, 2, 64, 91-92

counseling, 8, 28, 88-92

Telephone quitline counseling, 8

Theophylline, 115

Tobacco cessation

rates, 6

tobacco user identification, 78-79

Tobacco dependence, 4

brief treatment, 7

as chronic disease, 15-16 

Tobacco dependence treatment/intervention,

 2, 7, 8, 79-80

cost-effectiveness of, 134-138 

coverage, 2

five A’s model, 38, 39

Tobacco research, 8-9

Tobacco screening, 77-79

Tobacco tax increases, 16

Tobacco use 

in adults, 1

algorithm, 36

assessment, 5, 32, 35-36

cost of, 11

decrease in, 10

dependence, treatment model, 34

morbidity, mortality, 11

screening for, 36

status, 7, 11

Tobacco user, 4, 14

number of, 11

special populations, 6

Tobacco user identification, 40, 69, 70, 78-79

specialized assessment, 79-81

Transgender smokers. See Lesbian/gay/

 bisexual/transgender smokers

Treating Tobacco Use and Dependence, 13-14

Treatment. See also Counseling, Intervention 

model, 34

strategies, 17

Tricyclic antidepressants, 116

U-V

Unaided quit attempts, 9-10, 19

Valproate, 116

Varenicline, 8, 42, 44, 45 

clinical use of, 53-54

coding rules for, 108

drug interactions, 116

effectiveness of, 113-115

for intensive interventions, 66

Venlafaxine, 119

Veteran’s Health Administration, 2

Vital signs, 40, 70, 77

W-Y

Weight gain, 6, 33, 46, 62, 173-176

Withdrawal, 60

Women smokers, 6, 33, 156-157

effective treatments for, 147

Young adults/youth

counseling, 3

tobacco users, 11
Guideline Availability

This Guideline is available in several formats suitable for health care practitioners, the scientific community, educators, and consumers. 

The Clinical Practice Guideline presents recommendations for health care 

providers, with brief supporting information, tables and figures, and pertinent references.

The Quick Reference Guide is a distilled version of the clinical practice 

Guideline, with summary points for ready reference on a day-to-day basis.

The Consumer Version is an information booklet for the general public 

to increase consumer knowledge and involvement in health care 

decisionmaking.

The full text of the Guideline, with and without the text references and the 

meta-analyses references (listed by evidence table), is available by visiting 

the Surgeon General’s Web site at: www.ahrq.gov/path/tobacco.htm#Clinic.

Single copies of these Guideline products and further information on the 

availability of other derivative products can be obtained by calling any of 

the following Public Health Service organizations’ toll-free numbers:

Agency for Healthcare Research and Quality (AHRQ)

800-358-9295

Centers for Disease Control and Prevention (CDC)

800-311-3435

National Cancer Institute (NCI)

800-4-CANCER