36

Comparative Effectiveness of Smoking Cessation Treatments 

for Patients With Depression Evidence-based Synthesis Program

APPENDIX A: SEARCH STRATEGY

PubMed: Search on March 10, 2010 (yield = 463 articles)

((“smoking cessation”[MeSH Terms] OR (“smoking”[All Fields] AND “cessation”[All Fields]) 

OR “smoking cessation”[All Fields]) OR (“Smoking/prevention and control”[Mesh:noexp] 

OR “Smoking/therapy”[Mesh:noexp])) AND (“Depression”[Mesh] OR ((“Depressive 

Disorder”[Mesh:noexp] OR “Depressive Disorder, Major”[Mesh]) OR “Dysthymic 

Disorder”[Mesh]))

Embase: Search on March 10, 2010 (yield = 489)

‘depression’/de OR ‘agitated depression’/exp OR ‘atypical depression’/exp OR ‘depressive 

psychosis’/exp OR ‘dysphoria’/exp OR ‘dysthymia’/exp OR ‘endogenous depression’/exp OR 

‘major depression’/exp OR ‘masked depression’/exp OR ‘melancholia’/exp OR ‘mixed anxiety 

and depression’/exp OR ‘mixed depression and dementia’/exp OR ‘mourning syndrome’/exp OR 

‘organic depression’/exp OR ‘reactive depression’/exp OR ‘recurrent brief depression’/exp AND 

(‘smoking cessation’/exp/mj OR ‘smoking cessation program’/exp/mj)

PsycINFO: Search on March 10, 2010 (yield = 219)

(DE “Depression (Emotion)”) or (DE “Major Depression” or DE “Affective Disorders” or 

DE “Anaclitic Depression” or DE “Dysthymic Disorder” or DE “Endogenous Depression” 

or DE “Reactive Depression” or DE “Recurrent Depression” or DE “Treatment Resistant 

Depression”) and ((“Smoking Cessation” or (DE “Drug Rehabilitation”) and (DE “Tobacco 

Smoking”))

Cochrane Library: Search on March 10, 2010 (yield = 169)

Smoking cessation and depression (limit clinical trials)
37

moking Cessation Treatments 

Evidence-based Synthesis Program

EWER COMMENTS AND RESPONSES

Response

cope, and methods for this review clearly described?

Thank you.

ew and very clearly written Thank you.

propriate outcome measures warrants more attention on p 14 or p 17 line 8. 

l 2003 report of recommendations of the abstinence outcome measures work

y for Research on Nicotine and Tobacco (Hughes J. R., Keely J. P., Niaura R. S., 

Richmond R. L., Swan G. E. Measures of abstinence in clinical trials: issues and 

Nicotine Tob Res 2003; 5: 13–25).

We have further clarified outcome measures in the methods section. Operationalization of smoking cessation was informed by those used in Cochrane reviews of smoking cessation which is based on the Russel Standard (West R, Hajek P, Stead L, Stapleton J. Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction

2005;100(3):299-303). 

biological verification of self-report (CO or cotinine) in only a couple of studies 

d as a limitation in this literature. 

All included studies use biological verification of self-report smoking cessation. 

rch strategy is among the many strengths of the review. It may be implicit in 

moking”, but it would be worth indicating on p 13 and/or in Appendix A that 

acco” are subsumed in that category. Tobacco currently only appears under 

“Tobacco” and “nicotine” are not indexed under the MESH term “smoking.” Adding these terms yields an additional 81 articles of which none met our eligibility criteria. 

Thank you.

Thank you.

e opportunity to see this work. The key questions are succinctly and clearly 

quence. Language is clear and concise. Figure 1 page 13 is helpful. In general I 

s been well conducted and well summarized. 

Thank you.

on of bias in our synthesis of the evidence?

Thank you. 

check numbers Numbers are correct.

ould be easier for the reader if you consistently describe the comparisons being 

 it would be a lot easier to grasp this if the subtitle was: “Antidepressant therapy 

 placebo +co-treatment” rather than how it is written. Same issue occurs again 

 switch “antidepressants” and “behavioral”

We agree and have made the changes requested. 

--add in risk estimates Comparisons nonsignificant and risk estimates not reported.

e report appears to be rigorously objective. Thank you.

Acknowledged
38

moking Cessation Treatments 

Evidence-based Synthesis Program

Response

Acknowledged

Limiting the search to English Language only will introduce bias, as will 

o only the peer reviewed literature (publication bias). There may be other 

rogress. 

Non-English language articles are beyond the scope of this review. Inclusion of non–peer reviewed literature is controversial as these reports are often incomplete and can differ from final peer reviewed publication. An advantage of non-peer reviewed literature is a greater ability to detect publication bias. For this review, we thought the potential negatives of included these types of reports outweighed the potential advantages. 

ing to small positive effects of trials it is unclear whether these are statistically 

ant differences? Did they “show” effects? Or simply “suggest” effects? Or just 

be due to chance. Could the wording here be tightened so this is clearer?

We have added greater specificity to the language. 

r why hospital based interventions were excluded? If seeking to include trials 

ent depressive symptoms, then an inpatient setting might capture some of these? 

to the exclusion of relapse prevention trials may have excluded some direct or 

 efficacy of sequential treatment strategies (key question 4)

Stakeholders interested in outpatients and smoking cessation. However, we agree that including studies of relapse prevention could yield some indirect evidence but we thought that this would be too indirect for our purposes in this review. 

s on of interest to the VA that we have overlooked?

Acknowledged 

Acknowledged

y by McClure et al. appears to meet the criteria in Table 1 and is of particular 

en the focus on varenicline. If there is a reason for exclusion it would be 

and there would still appear to be value in addressing the findings as they relate 

s currently no mention of varenicline in the document. 

GE, Jack L, Catz SL, Zbikowski SM, McAfee TA, Deprey M, Richards J, Javitz 

cts and smoking outcomes among persons with and without probable lifetime 

arenicline. J Gen Intern Med. 2009 May;24(5):563-9. Epub 2009 Feb 24.

We identified and excluded McClure study because report did not provide data on rates of smoking cessation for the depressed subgroup by intervention arm. Therefore, we could not include these data in our analysis of the comparative effectiveness of smoking cessation interventions for depressed patients. 

ve reviews also seem worth citing in the background:

G, Montoya ID, George TP. Treatment of tobacco dependence in mental health 

ders. Can J Psychiatry. 2009 Jun;54(6):368-78. Review.

nterventions with comorbid populations. Am J Prev Med. 2007 Dec;33(6 

Thank you for this suggestion. We have added these to the background section.Acknowledged Acknowledged 
39

moking Cessation Treatments 

Evidence-based Synthesis Program

Response

 based on timing of outcome reporting: figure 2 page 20. I have trouble 

ead in the report results with what is detailed about trial flow in figure 2. 

ials were excluded based on their choice of outcomes, or their choice of 

imepoint post intervention. In general terms, excluding evidence on the basis 

ecommended, if the trials otherwise meet inclusion criteria (population, design, 

he 6 articles that reported outcomes of interest, but not at 6 and 12 months, it 

ul data do exist – but not in the published reports. Some description of these 

might be informative, even if they are not subsequently able to contribute to 

alyses, or be used to inform the evidence summary. This is also true for the 14 

report the outcome of interest in their publications but otherwise met inclusion 

ulation, intervention) – perhaps the outcome data you sought does exist, and 

rom investigators. 

As we described, few (n = 3) of the studies enrolled patients with depressive symptoms. Most included studies are secondary analysis, using history of depression. The studies excluded typically report smoking cessation outcomes, but not in the subgroup of interest (those with depression) and many are small without the power to evaluate interaction effects between depression and smoking cessation interventions. Also 6- and 12-month outcomes are clinically relevant. Contacting the authors for additional data is beyond the scope of these reviews. However, we’ve raised the possibility of missing studies with unpublished but relevant outcomes.

dence, and if making suggestions for a future research agenda, then 

e additional trials might be helpful: rather than undertaking new trials, 

 better use of existing data is also important. This can take the form of 

of existing trial data, or attempting individual patient data meta-analysis

The suggestions for patient level meta-analysis or secondary analysis of existing trial data has been incorporated into possibilities for future research.

nal suggestions or comments below. If applicable, please indicate the page and line numbers from the draft report.

out the topic in general and not the report. OK
40

moking Cessation Treatments 

Evidence-based Synthesis Program

Response

alence We added prevalence.

 include chantix? Yes, but no trials using this drug met our eligibility criteria. 

what the antidepressant trials are compared to We have clarified in text.

y: does “control condition” belong in this sentence Yes it does.

 rephrase this “...does treatment effectiveness differ by whether smoking 

n treatments are delivered concurrently or sequentially?”

We have made this change.

dding behavioral mood management counseling to _____what? We have clarified in text.

larify the sequential/concurrent text. perhaps add an example on line 16. “...

mple....”

We have clarified in text.

ht add sentence after “sequentially” that says, “It is plausible but unstudied” if 

We have added this sentence. 

ually pulled? You might rephrase this We have rephrased this sentence. 

k you should try and fit this on one page and definitely should add the setting to 

o define FTND

We have modified table and “FTND” is defined in the footnotes of Table 3. 

note it should be “approach” not “approached”. It would be nice to include a 

n this table as well as many of the others also. 

We have made this change and include summary estimates in the text, when available, for the comparisons of interest, smokers with depression by intervention arm. 

h antidepressant and behavioral to make the comparisons clearer We have changed all the title to make this clearer. 

--add in risk estimates We include risk estimates in the text, when available, for 

the comparisons of interest, smokers with depression by intervention arm.

fy what active control is We have added example of active control. 

rather than “of” We have made this change. 

ates would be helpful We include risk estimates in the text, when available, for the 

comparisons of interest, smokers with depression.

ntion rather than “interventions” We have made this change.

 the full sentence beginning in line 11-12 to the beginning of the paragraph We respectfully disagree. This sentence belongs in the 

paragraph about mood management treatments. 

“can make”???? We have clarified the language. 
41

moking Cessation Treatments 

Evidence-based Synthesis Program

Response

entioned in the document. Perhaps the basis for the McClure et al (2009) trial dent to me for KQs 1-4, but the data on adverse effects seem highly relevant 

nd use of varenicline for patients with MH diagnoses is of high interest within 

ently revised criteria for use that emphasize psychiatric stability. 

We did not exclude trials that used varenicline. No trials using varenicline met our eligibility criteria. Therefore, it is beyond the scope of this report to discuss adverse effects for therapies not included in included trials. We, however, now briefly discuss use of varenicline for veteran with mental health issues in the discussion section.

e more explicit in distinguishing history of depression from current depression 

criteria and from current depression symptoms based on exceeding assessment 

ntified language convention in p 23 line 11-13 does not seem to be applied 

ombines current depressive symptoms with current depression diagnosis. 

e 21 – among 3 studies that recruited participants with current depression, did 

articipants meet diagnostic criteria and others use assessments in the absence of 

atements to clarify history vs. current vs. either are p 25 line 7; p 29 line 23, p 

11, p 31 line 20, p 40 line 14, Table 10 footnote b. Consider adding a footnote to 

 the distinct meanings of current depression. 

The reviewer is correct that we combined current and historypositive studies. As outlined in our research questions, we assessed the comparative effectiveness of smoking cessation strategies of patients with a history of a depressive disorder or current significant depressive symptoms. We, however, planned a priori to conduct subgroup analyses by depression status but were unable to do so due to low number of studies per comparison. We note this as a limitation of our studyWe state the method of depression assessment for the three studies that recruited participants with current depression or elevated depressive symptoms on page 23 lines 9-12. We have clarified footnote b of table 10. 

stion 2, the dimension at issue appears to be recency (i.e., history vs. current) 

s 19-20). Severity per se can vary widely among those classified as currently 

was not reflected in analyses.

For Key Question 2, we were interested in depression status at time entering trial. This could be operationalized as type or symptom severity at study entry. No studies conducted subgroup or interaction effects based on symptom severity at study entry. Therefore, we only reported on two studies that identified results based on depression type. For Key Question 2, we clarify that we were interested in depression status at study entry throughout the revised report. We intended to conduct subgroup analysis by depression status but number of studies was too few. 

al way to report trial outcomes, however to increase clinical relevance of effect 

lpful to report NNT or to advocate that this be included in future reports. For 

sider quantifying effects with NNT where possible (e.g., p 40 line 11). 

According to the Cochrane Handbook, NNT cannot be combined for a summary estimate in meta-analysis. We, therefore use RR for our analyses. We, however, have computed a NNT for our significant summary effect for the addition of mood management treatments.

cussion, most subgroup analyses warrant cautious interpretation. A recent 

e 11 would help to emphasize that point (e.g., Sun X, Briel M, Walter SD, 

group effect believable? Updating criteria to evaluate the credibility of 

BMJ. 2010 Mar 30;340 doi: 10.1136/bmj.c117). It would also be useful to 

nalyses reported in the selected studies as a priori or post hoc (e.g., p 5 line 20).

Thank you for the citation. We have added this to the report. Also studies did not state that subgroup analyses were conducted a priori and, thus, powered to detect interaction effects. We noted this as a limitation.
42

moking Cessation Treatments 

Evidence-based Synthesis Program

Response

excluded patients with current/recent substance use or substance use disorders. 

orbidity of alcohol and other substance use disorders with smoking and 

 limitation to generalizability worth noting.

We have added this as a limitation. 

n the broader literature about the role of combination pharmacotherapy 

NRT; see Shah SD, Wilken LA, Winkler SR, Lin SJ. Review and meta

tion therapy for smoking cessation. J Am Pharm Assoc (2003). 2008 Sep

and this has resulted in guidance through VA Pharmacy Benefits (PBM-MAP 

for Use of Combination Therapy in Tobacco Use Cessation; http://www.pbm.

ww.pbm.va.gov) . This is an important area for future research on those with 

orth identifying in the Discussion and considering for the Executive Summary 

lso be cited on p 10 line 3 in the context of individual forms of NRT. P 39 line 

hat the 4 trials involved single forms of NRT and none involved combinations. P 

ast full sentence are other locations to raise this point.

We agree and stated this in our discussion of future research in and in the executive summary that combination therapies are an important area of future study. We have expanded this section and added VA PBM-specific information per the reviewer’s suggestion. We also have clarified that the NRT trials are single-form NRT trials. 

al relevance. Despite the absence of systematic analyses that address this 

seful to comment on whether/how current depression was addressed (e.g., 

-depressants or psychotherapy) other than in conditions that involved mood 

ropion, etc. , and whether any anti-depressant doses were in the therapeutic 

of depression (e.g., p 40 para 3). It seems important to comment on whether 

addresses effects of smoking cessation in the context of treatment resistant 

ated depression (e.g., p 41 para 2 or p 42 para 2). The guidance on p 44 para 

hat behavioral mood management and NRT are adequate in the context 

ated depression rather than encouraging concurrent patient engagement in 

nt care to address the depression. Note the contrast with the example on p 46 

 full sentence.

All but a few studies included in this report excluded MDD positive patients. Most patients included in this report could only be categorized as symptom positive, with no information on treatment resistance in the original papers. Therefore, we cannot comment on the effects of these smoking cessation strategies on patients with treatment resistant depression. Also we have clarified that we refer to the effects of antidepressants on smoking cessation. We were able to assess that antidepressant doses were in the therapeutic range. We have added this level of detail to the report. 

ifferential effects of mode of therapy could not be answered with available 

e of group vs. individual behavioral interventions has high relevance to 

sibility, it seems worth noting in regard to the heterogeneity of treatment 

e 8). Uncertainty about advantages of individual vs. group modality for mood 

ine 11) also would be useful to clarify.

We have added this clarification. 

ample description for Duffy; p 63 indicated 69% with current depression? Our numbers are correct. In Duffy et al., 69% of the total 

sample had depression but only 35% (n = 64) had comorbid depression and smoking at baseline. 

rt is thorough, well-written and objective. The reader gains a great deal of 

 review of studies. Several specific comments are provided below. With the 

mment about exclusion of studies relating to Figure 2 on page 20, most of these 

vely trivial, but attention to them may slightly strengthen the review.

Thank you.
43

moking Cessation Treatments 

Evidence-based Synthesis Program

Response

, the meaning of the following sentence is a bit opaque. This sentence could 

ed or rewritten: “Yet the extent to which level of depressive symptoms affects 

fforts has not yet been synthesized.”

We agree and have deleted this sentence.

 (going onto page 11), the sentence, “Treating depression first may lead to 

herence and, consequently, better cessation rates” while having face validity, 

on, and that point should be made clear here.

We agree and have clarified that this is plausible but not yet known. 

likewise the sentence, “Smokers with psychiatric comorbidities may benefit 

avioral counseling and 3 pharmacotherapy with longer therapeutic smoking 

s (i.e., exceeding 8 to 12 4 weeks) to reduce likelihood of dropout and 

 while a reasonable supposition actually poses a hypothesis to be examined, but oes not make that point entirely clear.

The original language does not state this as a known. Our language states that these approaches may be beneficial. We then state that this needs to be studied. 

ble 1: The exclusion for relapse prevention as an outcome is not entirely 

mean that studies which randomized participants who had already quit and 

 an outcome were excluded? If so, try to make this point clearer perhaps via an 

We have added a footnote that defines relapse prevention. 

 studies were excluded because the “Main outcome not reported at desired 

 the report gives no justification for the outcome intervals selected (self-reported 

6-12 months or [secondarily] abstinence at 3-4 months.) Considering that only 

mately included in the analysis, there must be more justification for the exclusion 

s simply on the basis of outcome interval when we really do not know the 

testing abstinence that might predict long term quitting.

We have further clarified outcome measures in the methods section. Operationalization of smoking cessation was informed by those used in Cochrane reviews of smoking cessation which is based on the Russel Standard (West R, Hajek P, Stead L, Stapleton J. Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction

2005;100(3):299-303). Also, the six excluded studies reported outcomes at end of treatment. End of treatment is not likely to be a good indicator of long-term smoking cessation. 

ntidepressants” should be singular “antidepressant.” We have made this change. 

6, oral naltrexone should not be called “long acting.” The parent drug has 

of 4 hours, the active metabolite an average half-life of 12 hours. The way 

it could be confused with the long acting injectable naltrexone which has 

asting 28 days.

The original paper refers to the naltrexone used in the study as “long acting.” We have clarified that the trial used the pill form of naltrexone.

ble 6, second and third columns, second row, change “approached” to 

We have made this change. 
44

moking Cessation Treatments 

Evidence-based Synthesis Program

Response

sider rewording the sentence, “Overall, we did not find enough evidence 

ntidepressants to other smoking cessation cotreatments for persons with 

f the studies looked at participants with prior histories of depression. If the 

depression and is trying to quit, most likely we would want her/him on an 

s effects on depression regardless of its lack of effect for smoking cessation. 

ould leave the impression that these patients should not be on antidepressants at 

Our primary outcome of interest was smoking cessation. Therefore, we were interested if adding antidepressants to smoking cessation cotreatments improves smoking cessation outcomes. It is an empirical question if persons with current depression undergoing a quit attempt receive relief from their depression with antidepressants therapy alone versus psychotherapy or combination psychotherapy and pharmacotherapy for depression. We, however, have reworded the sentence so that it is clear we are referring to antidepressant effects on smoking cessation alone. 

rite sentence, “Participants were randomized to 12 weeks of bupropion plus 

ting of 8 weeks of transdermal NRT and 13 sessions of group CBT smoking 

 or cotreatment plus placebo.” One potential suggestion is: “Participants were 

eeks of bupropion vs. placebo. Both groups received a cotreatment consisting of 8 

al NRT and 13 sessions of group CBT smoking cessation counseling.

We have changed the wording per the reviewer’s suggestion. 

tes some confusion by saying “Among participants who were history positive 

ion . . .” Whereas, earlier on line 6, the text indicates that “Evins (2008) 

ers who were history positive for unipolar depressive disorders.” The text in line 

ke all subjects were not history positive, but line 6 indicates that they were. It 

re paragraph beginning on line 6 needs reworking.

We have revised the paragraph in order to better explain that Evins (2008) recruited participants with lifetime histories of unipolar depression but then assessed cessation rates by current versus history-positive groups. 

he differences in n’s between men and women and the overall small sample size 

wing any conclusions from these data. Please either supply the quit rates for men 

 small samples sizes render the study very inconclusive. A general caveat about 

which occurs in other areas of the review appears on page 43, lines 5-11, but it 

 to include such caveats in the specific areas of the report they pertain to. This 

redundancy but may aid clarity.

We agree with the reviewer that the small number of participants limits our ability to draw any conclusion. We state this as a global limitation of many of our findings. The study did not report quit rates for men beyond end of treatment assessments. 

f possible it would be good add a column listing the interventions. The 

ted in other tables, but it is difficult for the reader to flip back and forth. The 

the adverse events is not too apparent if the reader is unsure of the intervention 

he adverse events.

We have added a column describing the interventions. 

he wording here could give the reader the impression that the interventions 

cacious, when, in fact, they have been insufficiently studied. An attempt to make 

al clause in the paragraph does not quite get there. This point should be explicitly 

We have clarified that these are understudied strategies that need further examination. 

sentence, “Smokers with depression are more likely to have increased levels of 

on and postcessation” is poorly phrased. How about, “Smokers with depression 

ave increased levels of negative mood both pre- and post-cessation.”

We have made this word change. 
45

moking Cessation Treatments 

Evidence-based Synthesis Program

Response

move word “elevated.” We removed this word.

e sentence, “Smokers with depression can make and maintain smoking 

 awkward and would benefit from rewording.

We have reworded this sentence. 

 report extremely clear and well-written. I learned a lot from the content, 

dom this important topic has been adequately studied.

Thank you.

– Which category would varenicline fit into? Also, I think it matters whether the 

g studied is bupropion or nortriptylline (both endorsed by the PHS guidelines) 

pressants. On the other hand, none of the antidepressant studies really showed 

s not necessary to separate them out.

We had insufficient number of trials to assess antidepressant effects by specific drug. We state this as a limitation. 

hange the heading for Column 2 in Table 10 to “...%reported in intervention 

e way it reads now, it appears that the control group was much more likely to 

verse effects, particularly in Hall, 1998. It was only after a few minutes that I 

ndicating that the intervention group experienced more. So, I would keep the 

ve the order in the column heading consistent with the order reported in each 

We agree and have made this change. 

e informative to have details of the disaggregated quality criteria scores for the 

rovided, I am not able to judge how trials scoring “fair” differed from those 

s would be best within the main body, but could be included in an appendix. 

s, the transparency of the review is compromised, and the leap to GRADE in 

We followed guidance in the EPC CER methods manual to report summary quality scores.

nformative and unhelpful when there are small numbers of trials. In addition, 

uded any trials not published in peer reviewed journals, making the rationale for 

nable. Thus, appendix D would be better removed.

We agree. The funnel plots were presented in the draft review for completeness but have been removed from the final review

s, displaying the outcome number (eg figure 3, 1.2.1) is confusing to the reader. 

moved from the plots.

This has been corrected.

only 1 stratum of trials, please remove the bottom summary estimate – it merely 

m summary estimate, complicates the plots and potentially confuses readers (eg 

total” – it is same as “subtotal” estimate)

This has been corrected.

helpful to order trials by the weight they contribute to the meta analysis – thus 

see which trial contributes most to the summary estimate of effect, and also 

be responsible for any heterogeneity.

We have made this change.

e and content among tables: table 9 page 34 includes a column marked “rating”, 

anation. Presumably this reflects methodological quality? Similar tables 

wing do not contain this column. 

We have deleted this column. 

 page 57 onwards are enormous and somewhat unwieldy. It is hard to see where 

nother starts. Could these be reorganised so there is clearer delineation among 

rt each new trial at the top of a page, even separate table for each trial?

We have disaggregated the evidence tables. Each table starts on a new page. 
46

moking Cessation Treatments 

Evidence-based Synthesis Program

DENCE TABLES

ess of Smoking Cessation Treatments for Patients With Depression

al., 2001

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

CBT for smoking cessation (ST) vs ST + CBT for 

n (CBT-D)

ndomized to treatment condition according to gender, 

pressive symptoms (BDI = 9), and level of nicotine 

ce

cessation intervention: 

l interventions

 group CBT sessions in 6 wk (2 sessions clustered 

it date) colead by two therapists (clinical psychologist 

ral fellows, interns in clinical psychologist, clinical 

ists) 

onents of smoking cessation therapy included treatment 

self-monitoring, self-management, nicotine fading, 

evention, social support

ne

n intervention: 

l interventions

our group CBT sessions in 6 wk (2 sessions clustered 

it date) colead by two therapists (clinical psych post

ellows, interns in clinical psych, clinical psychologists) 

tor intervention(s)

cessation intervention: 

l interventions

our group smoking cessation only CBT sessions in 6 wk 

s clustered around quit date) colead by two therapists 

sych postdoctoral fellows, interns in clinical psych, 

ychologists) 

Inclusion criteria: - Ages 18 to 70- Smoked for at least 1 yr (10 cigarettes/day)- History of MDDExclusion criteria: - Current depression- Substance use- Current weekly psychotherapy- Use of other tobacco products- Intent to use pharmacological aid for cessation- Psychotropic therapyAge: Mean (SD): 45.1 (9.27)Gender (n [%]): Female 107 (59.8%) Race/ethnicity (n [%]): White 174 (97.2%) Baseline depression assessment: - SCID- BDI (cutoff ≥ 9)- Mean (SD) = 7.8 (6.31)Smoking characteristics: - FTND = 6.8 (1.93)- Saliva cotinine = 383.7 ng/ml (170.59)Comorbid conditions (n [%]):- History of alcohol abuse 78 (43.6%)- History of drug abuse 60 (35.8%)

Follow-up rate:6 mo = 91%12 mo = 92%Important baseline differences: NoneOutcomes of interest 1) Abstinence rate: 

6 mo 12 mo

ST 24.7 24.7CBT 24.4 32.52) Medication adherence rate: NR3) Differential effects by gender: NA4) Differential effects by depression status: NA5) Differential effects by treatment sequencing: NAReport adverse effects? No

General comments: NoneApplicability cautions: None Study-level quality assessment: GoodMeasure of smoking adequate? YesAssessment of adverse effects adequate? No

one

n intervention: None

tact time/proportion of sessions completed:

ttended out of 8 possible:

5.8 of 8 = 72.5% 

ion 5.9 of 8 = 73.7% 

t sequencing: Not done
47

moking Cessation Treatments 

Evidence-based Synthesis Program

ner, 1999

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

mpared the added effectiveness of naltrexone to behav

seling (6 sessions) vs placebo treatment

l counseling + Naltrexone (n = 40) vs behavioral coun

acebo (n = 40)

cessation intervention: 

l interventions

al sessions based on the American Lung Association 

essation program (modified) conducted by trained 

nsisted of fading, target quit date and coping skills for 

nd withdrawal symptoms

eld 3 and 5 days prior to quit date, then weekly x 1 mo

e, 25 mg/day 3 to 5 days prior to quit, increased to 50 

n quit date, then increased to 75 mg/day if tolerated x 1 

n intervention: 

ddition to behavioral intervention

tor intervention(s) 

cessation intervention: 

l interventions

ssions as described above

5, 50, then 75 mg/day x 1 mo

n intervention:

bove

tact time/proportion of sessions completed: 

67.5%) subjects in both arms completed the treatment; 

 sessions attended NR

t sequencing: NA

Inclusion criteria: - Ages 18 to 65- Smoked ≥ 20 cigarettes/day- Smoked before leaving house when awakened- Made at least 1 attempt to quit in the pastExclusion criteria: - Current or history of psychiatric disorder other than MDD; not clearly specified - Current major medical illness - Current MDD, substance abuse or psychotic disorder excludedAge: Mean (SD): NR for whole sample Range 18 to 65Gender (n [%]): N (65) NR for entire sampleFemaleNaltrexone 20.4 of 30 (68%)Placebo 22.8 of 38 (60%)Race/ethnicity (n [%]): NRBaseline depression assessment: - Schedule for Affective Disorders, Lifetime version- History of depressionNaltrexone 12.5 of 30, (42%)Placebo 20 of 38 (53%)Smoking characteristics: Mean (SD):Self-report usage: - Naltrexone 34.3 (11.9) cigarettes/day- Placebo 30.3 (10.1) cigarettes/dayCotinine level:- Naltrexone: 262 (130) ng/ml- Placebo: 271 (110) ng/mlComorbid conditions (n [%]): History of major depression:- Total 37 of 68 (55%)- Naltrexone 12.6 of 30 (42%)- Placebo 20 of 38 (53%)

Follow-up rate: NRImportant baseline differences:Age p < .004Naltrexone 39.7 (8.0) yrPlacebo 33.8 (8.2) yrNaltrexone: 75% (30 of 40) patients started study, 25% dropped out prior to quit datePlacebo: 95% (38 of 40) patients started study, 5% dropped out prior to quit dateOutcomes of interest3 mo NR for entire population6 mo quit rate (n, %,OR, p)Naltrexone 30 (26.7) 1.9 nsPlacebo 36 (15.2)1) Abstinence rate:End of treatment (4 wk)Naltrexone 14 of 30 (46.7%)Placebo 10 of 38 (26.3%)OR 2.5, ns2) Medication adherence rate: NR3) Differential effects by gender:End of treatment (4 wk) ORWomen (44) 3.5Men (22) 1.46 mo quit rate:

Nal Pla OR p

Women 27.8 7.4 4.6 .07

General comments:Differential dropout prior to quit date:-Naltrexone 10 of 40 (25%)- Placebo 2 of 40 (5%)Then differential dropout during study in the opposite direction:- Naltrexone 3 of 30 (10%)- Placebo 11 of 38 (29%); reason given was that the pill was not helpfulApplicability cautions:- Mean age < 40- More than 60% femaleStudy-level quality assessment: FairComments: - Poor description of exclusion criteria- Poor description of depression measure- Unequal dropout rate prior to quit date- No ITT analysis with 25% dropout rate in one arm but only 5% in otherMeasure of smoking adequate? Yes; cotinineAssessment of adverse effects adequate?Original study questionnaire
48

moking Cessation Treatments 

Evidence-based Synthesis Program

ner, 1999

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

4) Differential effects by depression status: 4 wk OR only present or absent givenNegative (32) 0.8Positive (36) 8.46 mo quit rate: Nal Pla ORSmokers 28.6 9.1 4.0 nsWithin depressed (4 wk)Women (26) 4.4Men (10) 2.76 mo quit rate: Nal Pla OR pWomen 22.2 0.0 3.4 .045) Differential effects by treatment sequencing: NAReport adverse effects? Yes -11 naltrexone dropout- Minnesota Withdrawal Symptom Scale, 6 pt scale; side effects on original 3-point scale- List- Panic attack- Malaise- Sleeplessness- Lack of concentration- Nausea and vomiting- Disorientation- Tremors
49

moking Cessation Treatments 

Evidence-based Synthesis Program

et al., 2002

ons Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

uble-blind trial of sertraline titrated to 200 mg daily (n 

lacebo (n = 66) following 1 wk placebo run-in;

 received behavioral intervention

cessation intervention: 

l interventions

5-minute individual behavioral session that included 

moking cessation techniques (orientation to health risk, 

f cessation, coping skills for withdrawal symptoms and 

elapse) 

50 mg daily wk 1

aily wk 2aily wk 3aily wk 4-9

ication taper

n intervention: 

l interventions

cessation intervention augmented with a supportive ap

manage negative affect 

tor intervention(s)

cessation intervention: 

l interventions

ntervention

acebo

n intervention: 

l interventions

ntervention

tact time/proportion of sessions completed: 

ring 12 wk intervention, each lasting about 45 min

t sequencing: NA

Inclusion criteria: - ≥ 1 MDE that remitted ≥ 6 mo prior to study- Ages 18 to 70 - ≥ 20 cigarettes/day x ≥ 1 yr - ≥ Prior quit attempt- Decreased cigarettes by ≥ 50% on quit dateExclusion criteria: - Serious medical illness - Psychotropic medication- MDD- Alcohol or drug dependence- PTSD, panic disorder, bulimia, anorexia nervosa within past 6 mo- Other lifetime major Axis I disorders- PregnancyAge: Mean (SD): 44.5 (10.7)Gender (n [%]): Female 85 (63.4%)Race/ethnicity (n [%]): White 117 (87.3%)Baseline depression assessment: BDI-21 8.0 (7.7)CES-D 14.9 (10.8)HDRS 4.8 (4.4)Smoking characteristics: *- Yr smoking: 25.4 (10.5), 26.6 (10.8)- Cigarettes/day: 29.6 (11.5), 26.9 (9.0)- FTND: 7.1 (2.4), 6.1 (2.4)* = Placebo, interventionComorbid conditions: NR

Follow-up rate:100 of 134 (74.6%) at quit date; NR for intervention periodImportant baseline differences:FTND lower for intervention group: 6.1 (2.4) vs 7.1 (2.4)Outcomes of interest1) Abstinence rate: Post-quit day (randomization)Wk 6 (10): 19 of 66 (28.8%) placebo vs 23 of 68 (33.8%) interventionWk 30 (34): 11 of 66 (16.7%) placebo vs 8 of 68 (11.8%)When analysis was limited to the 100 subjects enrolled until quit date, there were no statistically significant differences in abstinence rates2) Medication adherence rate: NR3) Differential effects by gender: NR4) Differential effects by depression status:No interaction effect for treatment by single vs recurrent depression or baseline depression status5) Differential effects by treatment sequencing: NAReport adverse effects? Yes-Dizziness, agitation, spaciness, diarrhea- 7 placebo, 4 intervention dropped out by wk 4 due to AE

General comments:Table 2 gives AE rates but suspect scaleApplicability cautions: No concernsStudy-level quality assessment: GoodMeasure of smoking adequate? YesAssessment of adverse effects adequate? No
50

moking Cessation Treatments 

Evidence-based Synthesis Program

 al., 2006

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

 smoking, depression, alcohol abuse telephone counseling 

s enhanced usual care of brief counseling and referral to ap

ervices for substance use/abuse and/or depression (n = 91)

pants were nonterminal head and neck cancer patients

cessation intervention: 

l interventions

seline assessment and brief counseling with RN using 

ured instruments

 sessions, planned telephone counseling and workbook

was RN trained specifically for intervention

luded tobacco tactics, drinking decisions, and mood man

sing goal setting, self-monitoring, analyzing behavioral 

ts, coping, and social skills training

as needed

 replacement and/or bupropion 

n intervention: 

l interventions: None additional

ntidepressants on individual basis (bupropion, paroxetine, 

 sertraline)

tor intervention(s)

cessation intervention: 

l interventions

seline assessment and brief counseling with RN using 

ured instruments

s needed to smoking cessation, alcohol treatment, or 

alth evaluation according to insurance and ability to pay 

nd time spent standardized)

isting all services available in area (e.g., Alcoholics 

us)

fied as prescribed on individual basis

n intervention: 

l interventions

, dependent on individual referral

ne specified 

tact time/proportion of sessions completed: 

82.8%) completed all aspects of intervention 

t sequencing: NA

Inclusion criteria: - Diagnosis head and neck cancer- Comorbid smoking, depression, or problem drinking- Older than age 18- HDRS >20 or severe drinkingExclusion criteria: - Pregnant- Non-English- Terminal illness- Unstable psychiatric illnessAge: 57 (9.9) Gender (n [%]) : Male 155 (84%)Race/ethnicity (n [%]): White 166, (90%)Other 18 (10%)Baseline depression assessment:Geriatric Depression Scale-short form; score > 4 at baseline and follow-up (69% of sample depressed)Smoking characteristics: Self report; 74% of sampleComorbid conditions (n [%]):- Depression 127 (69%)- Alcohol 52 (28%)

Follow-up rate:84% at 6 mo for total population Important baseline differences: NoneOutcomes of interest- Quit rate at 6 mo for all smokers (n = 136) - Intervention, 35 of 74 (47%) - Usual care, 19 of 62 (31%)1) Abstinence rate:At 6 mo for those depressed at baseline (n = 64):Intervention 51% (18 of 35) Usual care 17% (5 of 29)2) Medication adherence rate:NR3) Differential effects by gender: NR4) Differential effects by depression status: NR5) Differential effects by treatment sequencing:Not doneReport adverse effects? No List

General comments:This study tried to treat smoking, alcohol abuse, and depression concomitantly in a group of head and neck cancer survivorsOnly 64 participants had depression and also smoked at baseline Depression was mild to moderate and excluded those with HDRS > 20Used Geriatric Depression Scale-short form > 4 to define depressedApplicability cautions: Good; 52% vets, correct age, male; all head and neck cancer patientsStudy-level quality assessment: GoodMeasure of smoking adequate? No; no biochemical validation of self-report status; self-report alone may underestimate current smokers Assessment of adverse effects adequate? No
51

moking Cessation Treatments 

Evidence-based Synthesis Program

al., 2008

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description:

on = 97

or = 102

andomization on level of nicotine dependence, failed 

treatment with NRT and/or CBT, current or past UDD 

s of group CBT + 8 wk NRT + 12 wk bupropion SR vs s of group CBT + 8 wk NRT + placebo

cessation intervention: 

l interventions

group CBT with groups up to 6 patients plus weekly vis

dy psychiatrist (session 1 treatment rationale; session 2, 

behavioral suggestions for using NRT; sessions 3 to13, behavioral strategies of maintenance of abstinence) 

T sessions did not address depression

on 12 wk (150 mg/day for 3 days and then 150 mg BID)

wk (21 mg patches for wk 2 to 6; 14 mg patches wk 7 

mg patches wk 9 and 10)

n intervention: 

tor intervention(s) 

cessation intervention: 

l interventions

bove: 13 wk of group CBT with groups up to 6 patients 

ly visit with study psychiatrist

T sessions did not address depression

wk (21 mg patches for wk 2 to 6; 14 mg patches wk 7 

mg patches wk 9 and 10)

12 wk (same schedule as bupropion)

n intervention: 

tact time/proportion of sessions completed:

0% dropped out

t sequencing: NA

Inclusion criteria:- Ages 18 to 70- Smoked > 10 cigarettes/day for more than 2 yr- Lifetime diagnosis of UDD (so current and history of depression)- History of depression or current depressionExclusion criteria: - Substance use disorder- Other psychiatric disorders- Current use of nicotine-containing products, psychotropic medications, or behavioral smoking cessation treatmentAge: Mean (SD): 43 (11) Gender (n [%]): Female 97 (49%)Race/ethnicity (n [%]): NABaseline depression assessment: HAM-D-6Smoking characteristics: - 7 day point prevalence- FNTDComorbid conditions (n [%]): Lifetime anxiety 79 (40%)

Follow-up rate:99 of 199 = 49.7%Important baseline differences:More men and fewer depression episodes in placebo armOutcomes of interest1) Abstinence rate:At 13 wk post-baseline:36% bupropion and 31% placebo using intent to treat analyses2) Medication adherence rate: NR3) Differential effects by gender: Not done4) Differential effects by depression status: Yes- Current UDD:33% (15 of 45) bupropion vs 31% (14 of 45) in placebo were abstinent - History of UDD:39% (20 of 52) bupropion vs 32% (18 of 57) in placebo were abstinent 5) Differential effects by treatment sequencing: Not doneReport adverse effects? No 

General comments: NoneApplicability cautions: Very high dropout rateStudy-level quality assessment: GoodMeasure of smoking adequate? YesAssessment of adverse effects adequate? NA
52

moking Cessation Treatments 

Evidence-based Synthesis Program

94

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

 of small group smoking cessation treatment + 5 ses

BT mood management + nicotine gum vs 5 sessions of 

up smoking cessation treatment + nicotine gum

ory negative:

= 53

0

ory positive:

= 17

29

cessation intervention: 

l interventions

essions over 8 wk (2 x for first 2 wk)

sions were “standard” smoking treatment: information 

g, gum use, quit plan 

on was delivered by 1 MD from preventive medicine 

and 1 PhD psychologist

mg gum as needed for 8 wk

9-12 wk

carry “shelf” gum for high-risk situations

n intervention: 

l interventions

 of CBT focused on mood management: 

ng of thoughts, daily activities, interpersonal contacts 

n increasing thoughts and activities related to healthy 

 to not smoking

ng pleasant activitiesng pleasant social contacts

 training

ng and modifying maladaptive thoughts

ealist life goals (manual available) 

tor intervention(s)

cessation intervention: 

l interventions

, 8 wk

up; only support; leader did not condone any specific 

ns or offered any

m as above

n intervention: None

tact time/proportion of sessions completed: NR

t sequencing: NA

Inclusion criteria: - 10+ cigarettes per day- Ages 18 to 65 Exclusion criteria: - Heart disease - Angina, vasospastic disease - Current or past peptic ulcer- Temporomandibular joint disease- Hypertension- Life-threatening illness- Alcohol or drug problems in past 6 mo- Current treatment for psychiatric problems- History of psychiatric hospitalization in past yr- Pregnant or nursing- Current MDD screened outAge: Mean (SD): 40.6 (9.2)Gender (n [%]): Men 71 (48%)Women 78 (52%)Race/ethnicity (n [%]): White 131 (88%)Baseline depression assessment: - DIS used to assess history of MDD, n = 46 (31%) history positive- BDI:History positive n = 6.39 (5.9)History negative n = 4.58 (4.6)Smoking characteristics: 24.9 (10.9) cigarettes/day26.7 (13.9) CO levelFTND tolerance scale 6.4 (1.9)Regular smoking yr 22.1 (9.5)Comorbid conditions: NR

Follow-up rate: NR; subjects with missing data were coded as smokingImportant baseline differences: NROutcomes of interest1) Abstinence rate:Wk 12 rates (from baseline)MDD history negative: Control 26 of 53 (49%)CBT 23 of 50 (46%)MDD history positive:Control 8 of 17 (47%)CBT 20 of 29 (69%)Wk 52MDD history negative: Control 13 of 53 (25%)CBT 8 of 50 (16%)MDD history positive:Control 4 of 17 (24%)CBT 10 of 29 (34%)2) Medication adherence rate: NR3) Differential effects by gender: NR4) Differential effects by depression status:See above for unadjusted rates; the diagnosis x treatment group interaction was significantAmong only those with MDD history positive, 10 of 29 (34%) vs 3 of 17 (18%) at 1 yr5) Differential effects by treatment sequencing: NAReport adverse effects? No

General comments: NoneApplicability cautions:- Current MDD or other psychiatric treatment excluded- Volunteer reactive sampleStudy-level quality assessment: Fair to poorComments:- Randomization and allocation NR- Baseline characteristics by intervention NR- Follow-up rates NR- Adherence NR- Dropout NRMeasure of smoking adequate? YesAssessment of adverse effects adequate? NR
53

moking Cessation Treatments 

Evidence-based Synthesis Program

996

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

oral treatments) x 2 (gum vs placebo) factorial design; 

by MDD history and cigarettes smoked

vioral arms 10-session group over 8 wk; quit date set 

roup session; groups 5-12 patients

 in 2 x 2 NR; n’s below collapse across 1 treatment 

ory negative:

ucation (control) n = 74

3

um n = 82m n = 75

ory positive:

= 23

21

um n = 21m n = 23

cessation intervention: 

l interventions

essions based on Hall 1994

anagement” CBT focused as described in Hall 1994; 

” smoking treatment: information on smoking, gum use, 

on was delivered by weekly supervision from PhD 

ist including review of audiotapes

mg gum at session 3 (quit date) for 8 wk

least 1 piece per hr for at least 12 hr/day during first 3 wk

wk 4-8

9-12 weeks

carry “shelf” gum for high-risk situations

 abstinent from all NRT

Inclusion criteria: - 10+ cigarettes per day- Ages 18 to 65 Exclusion criteria: - Heart disease- Ulcers- Oral thrush- Current alcohol or drug problems- Hypertension- Pregnancy- Current mental health treatment- Use of psychoactive drugs- Physician letter indicating that patient is healthy- Current MDD excludedAge: Mean (SD): 39.7 (NR)Range: 22 to 65Gender (n [%]): Women 105 (52%)Men 96 (48%)Race/ethnicity (n [%]): White 185 (92%)Baseline depression assessment: - DIS used to assess history of MDD; 22% of 201 history positive- BDI 6.71 (5.43)Smoking characteristics: - 23.8 (9.8) cigarettes/day- 27.2 (11.81) CO level- Regular smoking yr 21 (NR)Comorbid conditions: NR

Follow-up rate: NR; subjects with missing data were coded as smokingImportant baseline differences:NROutcomes of interestNo effect for treatment gum dose, MDD history, or interaction1) Abstinence rate:Wk 12 rates (from baseline)MDD history negative: Control: 26 of 74 (35%)CBT: 29 of 83 (35%)Placebo gum: 28 of 82 (34%)Active gum: 27 of 75 (36%)MDD history positive:Control: 8 of 23 (35%)CBT: 10 of 21 (48%)Placebo gum: 11 of 21 (52%)Active gum: 7 of 23 (30%)Wk 52MDD history negative: Control: 17 of 74 (23%)CBT: 23 of 83 (28%)Placebo gum: 21 of 82 (26%)Active gum: 19 of 75 (25%)MDD history positive:Control: 5 of 23 (22%)CBT: 7 of 21 (33%)Placebo gum: 7 of 21 (33%)Active gum: 5 of 23 (22%)2) Medication adherence rate: NR3) Differential effects by gender: NR4) Differential effects by depression status:See above for unadjusted rates; the diagnosis x treatment group interaction was not significant5) Differential effects by treatment sequencing: NAReport adverse effects? No

General comments:Caution: 2 x 2 factorial but data presented as if a 4-arm study, so each subject is double countedApplicability cautions:- Current MDD or other psychiatric treatment excluded- Volunteer reactive sample- Participants had to pay $75 depositStudy-level quality assessment: FairComments:- Randomization and allocation NR- Baseline characteristics by treatment group NR- Follow-up rates NR- Adherence NR- Dropout NRMeasure of smoking adequate? YesAssessment of adverse effects adequate? NR
54

moking Cessation Treatments 

Evidence-based Synthesis Program

996

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

n intervention: 

l interventions

focused on mood management:

ng of thoughts, daily activities, interpersonal contacts 

n increasing thoughts and activities related to healthy 

 to not smoking

ng pleasant activitiesng pleasant social contacts

 training

ng and modifying maladaptive thoughts

ealistic life goals (manual available) 

tor intervention(s) 

cessation intervention: 

l interventions

lth education

” smoking treatment: information on smoking, gum use, 

developed and modified each week

der provided health information and facilitated group 

 

n intervention: None

tact time/proportion of sessions completed: NR

t sequencing: NA
55

moking Cessation Treatments 

Evidence-based Synthesis Program

998

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

 health education) x 2 (nortriptyline vs placebo) 

T (n = 51)

ory positive n = 17 (33.3%)

th education (n = 48)

ory positive n = 15 (31.3%)

BT (n = 52)

ory positive n = 17 (32.7%)

ealth education (n = 48)

ory positive n = 16 (33.3)

cessation intervention: 

l interventions

ood management” CBT as described in Hall 1994

roup sessions over 8 wk

e 5-11 patients

sed on mood management skills to manage dysphoria 

ain nonsmoking and included methods to increase 

ncy of pleasant activities and decrease relapse-related 

nd techniques for increasing positive social contacts, 

g negative contacts, and improving relationships.

on delivered by 3 PhD psychologists

ind; MD visits wk 1, 2, 3

ine hydrochloride at therapeutic dose for depression; 25 

r 3 days; increased to 50 mg/day for 4 daysessed at wk 2

eased to 75 mg/day if therapeutic level not attained; 

to 100 mg/day if necessary at wk 6

se 100 mg/day; maintenance to wk 12

ng wk 13 (whenever active drug was titrated; someone 

 was titrated)

n intervention: 

l interventions

 of CBT (smoking/mood management) as above

Inclusion criteria: - 10+ cigarettes per day- Ages 21 to 65 Exclusion criteria: - Heart disease or ECG abnormalities- “Other reasons”- Current mental health treatment- Use of psychoactive drugs- Current MDD- Alcohol or other non-nicotine drug useAge: Mean (SD): Drug + CBT 41.7 (9.4)Drug + health education: 40.7 (9.6)Placebo + CBT: 40.0 (9.9)Placebo + health education: 39.4 (9.7)Gender (n [%]): Women n = 110 (55%)Men n = 89 (45%)Race/ethnicity (n [%]): White 173 (89%)Baseline depression assessment: DIS used to assess history of MDD:MDD history positive n = 65 (32.7)BDI:MDD history positive n = 7.2 (5.6)MDD history negative n = 5.5 (2.2)Smoking characteristics: Range of mean (SD) for the 4 groups:- FTND 5.4 (2.2) to 5.2 (2.2)- Yr smoking 21.7 (10.0) to 23.0 (10.7)- Daily cigarettes 21.1 (7.6) to 24.9 (12.1)Comorbid conditions: NR 

Follow-up rate: N = 47 (24%) dropped out of treatment No difference in psychological intervention or history of MDD in dropout rates but dropout higher in placebo drug (30%) vs active drug (17%) (or = 2.01; 1.05-4.06)Important baseline differences: NoneOutcomes of interest1) Abstinence rate:ITT analyses abstracted here:Wk 12 rates (from baseline)MDD history negative: Drug + CBT 56%, 19 of 34Drug + health education 61%, 20 of 33Placebo + CBT 20%,7 of 35Placebo + health education 31%, 10 of 32MDD history positive:Drug + CBT 47%, 8 of 17Drug + health education 47%, 7 of 15Placebo + CBT 41%,7 of 17Placebo + health education 19%,3 of 16 Wk 64MDD history negative:Drug + CBT 35%, 12 of 34Drug + health education 36%, 12 of 33Placebo + CBT 20%, 7 of 35Placebo + health education 22%, 7 of 32MDD history positive:Drug + CBT 24%, 4 of 17Drug + health education 20%, 3 to 15Placebo + CBT 29%, 5 of 17Placebo + health education 13%, 2 of 16

General comments:Randomization stratified by depression statusApplicability cautions:- Current MDD or other psychiatric treatment excluded- Volunteer reactive sampleStudy-level quality assessment: GoodComments:Adherence rate to behavioral treatment NRMeasure of smoking adequate? YesAssessment of adverse effects adequate? Yes
56

moking Cessation Treatments 

Evidence-based Synthesis Program

998

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

tor intervention(s)

cessation intervention: 

l interventions

lth education

der provided health information and facilitated group 

ent of quit plan; modified quit plan each week but only 

n sessions (5-11patients per group) over 8 wk. 

ncluded paper-and-pencil exercises, informational 

brief didactic presentations, homework assignments, 

ng monitoring

 above

n intervention: 

l interventions: Drug as above

tact time/proportion of sessions completed: NR

t sequencing: NA

2) Medication adherence rate:Capsules did not differ by condition or drug (active vs placebo)3) Differential effects by gender:Gender by MDD history interaction significant; MDD history positive women had poorer abstinence rates than MDD history negative (or =2.05; 1.32-3.23) but not for MDD history positive men (p = 0.20)Women:Wk 12MDD history positive 38%MDD history negative 53%Wk 64MDD history positive 20%MDD history negative 37%Men:Wk 12MDD history positive 61%MDD history negative 52%Wk 64MDD history positive 37%MDD history negative 31%4) Differential effects by depression status:See above for unadjusted rates for main effect for drug; 24% vs 12% placebo achieved continuous abstinenceThe diagnosis (i.e., MDD history) by psychological treatment by drug interaction was not significantBehavioral treatment condition by MDD history was significant
57

moking Cessation Treatments 

Evidence-based Synthesis Program

998

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

MDD history positive assigned to CBT did as well as MDD history negativeMDD history positive assigned to control were less likely to be abstinent than those assigned to CBTDrug by diagnosis was not significantThe diagnosis x treatment group interaction was not significant5) Differential effects by treatment sequencing: NAReport adverse effects?- Measured by checklist- Dry mouth 78% drug vs 33%or 7.0; 95% CI 3.73 to 13.17- Lightheaded 49% vs 22%or 2.42 1.85-6.35- Shaky hands 23% vs 11%or 2.42; 1.11-5.29- Blurry vision 16% vs 6%3.00; 1.12-7.99
58

moking Cessation Treatments 

Evidence-based Synthesis Program

l., 2006

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

act and referral control (n = 159) vs staged-care inter

 = 163)

cessation intervention: 

l interventions

ized motivational feedback based on the stages of 

odel (15 min session given at baseline, 3, 6, and 12 mo

 contemplation stage were also offered counseling

treatment program of CBT; six 30 min sessions of 

 treatments over 8 wk offered by one of two therapists 

l psychologist or PhD psychologist) 

isted of quit plan that was iteratively revised, quite date, 

about reasons for smoking, information about risks/

f quitting, information on nutrition and exercise, mood 

g, discussion of ways to increase pleasant moods and 

egative ones, use of behavioral skills to reduce relapse 

elation and social support skills. 

d 10+ cigarettes got 21 mg patch for 6 wk, 14 mg wk 

wk 9-10

NRT, could request bupropion (dose NR)

n intervention: None

tor intervention(s) 

cessation intervention: 

l interventions

act; list of referrals to smoking cessation programs and 

ing guide

ne

n intervention: None

tact time/proportion of sessions completed: NR

t sequencing: See above

Inclusion criteria: - Diagnosis of current depression based on PRIME MD- Smoked 1+ cigarettes/day in week prior to enrollment- Enrollment as a patient in one of four participating sitesExclusion criteria: - Under age 18- Non-English speaking- History of bipolar- Contraindicated to use of pharmacological treatments- Dementia or other disorders interfering with comprehension of materialsAge: Mean (SD): Control (n = 159) 42.2 (12.8) Staged care (n = 163) 41.5 (12.4)Median: NRRange: NRGender (n [%]):Male 98 (30.4%)Female 224 (69.6%)Race/ethnicity (n [%]): White 220 (68.3%)Baseline depression assessment: PRIME-MD + to be enrolledBDI-II:Control 21.4 (10.9)Staged care 20.6 (11.7)DISDSM-IV + MDD:Control 155 (97.5)Staged care 152 (93.3)Current MDD:Control 133 (83.7)Staged care 135 (82.8)Recurrent MDD:Control 89 (57.4)Staged care 79 (52.0)

Follow-up rate:3 mo:Control (n = 129; 81%)Intervention (n = 138; 85%)6 mo:Control (n = 120; 75%)Intervention (n = 125; 77%)12 mo:Control (n = 112; 70%)Intervention (n = 113; 69%)18 mo:Control (n = 110; 69%)Intervention (n = 122; 75%)Important baseline differences:Control had higher % of lifetime nicotine dependence: 74.7% vs 64.2% (not correlated with outcomes)Outcomes of interest1) Abstinence rateRates based on ITT analyses (missing = smoker)Intervention: 3 mo: 22 of 163 (13.5%)6 mo: 23 of 163 (14.11%)12 mo: 23 of 163 (14.11%)18 mo: 30 of 163 (18.4%)Control:3 mo: 15 of 159 (9.43%)6 mo: 25 of 159 (15.73%)12 mo: 15 of 159 (9.43%)18 mo: 21 of 159 (13.21%)Gee model:Main effect for treatment at 12 and 18 mo (completed only on responders) OR = 4.459 (95%) CI = 1.04 to 19.93P = 0.04412) Medication adherence rate: NR

General comments: NoneApplicability cautions:- Patients recruited from large HMO- Patients did not need to have intention to quit to enrollStudy-level quality assessment: GoodMeasure of smoking adequate? YesAssessment of adverse effects adequate? NR
59

moking Cessation Treatments 

Evidence-based Synthesis Program

l., 2006

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

Smoking characteristics: FTND:Control 4.2 (2.6)Staged care 3.8 (2.4)Number of cigarettes/day:Control 15.3 (10.3)Staged care 15.8 (10.0)CO at baseline:Control 15.2 (10.2)Staged care 15.5 (9.9)Comorbid conditions: NR

3) Differential effects by gender: NR4) Differential effects by depression status:- BDI-II not related to outcomes- Analyses conducted in only MDD (n = 307) with same pattern of results; results not shown5) Differential effects by treatment sequencing: NAReport adverse effects? No
60

moking Cessation Treatments 

Evidence-based Synthesis Program

s, et al., 1999

tions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

tion description:

upropion + behavioral intervention (n = 153) vs 150 

avioral intervention (n = 153) vs 300 mg + behavioral 

on n = 156) vs placebo (n = 153)

 cessation intervention: 

al interventions

et quit date after 1 wk of medication

lized message to stop smoking

p materials based on NCI program

-person individual counseling (10-15 min) by study as

weekly visits x 7 wk, then at 8, 12, 26, and 52 wk

ned 3 days after target quit date and at 4, 5, 7, 8, 9, 10, 

o

ion SR 50 mg BIDion SR 150 mg am + placebo pmion SR 150 mg daily x 3 days, then 150 mg BID

gs given for 7 wk

on intervention: None

ator intervention(s) 

 cessation intervention: 

al interventions

ntervention groups

BID for 7 wk, n = 153

on intervention: Nonentact time/proportion of sessions completed: 

5 (75%) completed 7 wk intervention

nt sequencing: NA

Inclusion criteria: - Age ≥ 18- Smoked ≥ 15 cigarettes/day for past yr- Motivated to stop smoking- Good general healthExclusion criteria: - History of head trauma, predisposition to seizures, anorexia nervosa, or bulimia- Current depression - Pregnancy - History of alcohol or substance abuse within past yr- Personal or family history of seizure disorder- Psychotropic medication use or NRT - Previous use of bupropion- Use of other tobacco productsAge: Mean (SD): 42 to 43 Median: NRRange: NRGender (n [%]): Female 336 (54.6%)Race/ethnicity (n [%]): White 591(96%)Baseline depression assessment: BDI-21, score range 0-63 Mean (SD) ranges from 4.1 (4.2) to 4.7 (5.0)SCID for lifetime MDD, total n = 114Smoking characteristics: Mean (SD) cigarettes/day range from 26.2 (8.5) to 27.5 (9.6)Previous serious quit attempts range from 3.5 (3.4) to 4.3 (5.4)FTND range from 7.1 (1.7) to 7.3 (1.7)Comorbid conditions (n [%]): Lifetime alcohol dependence, n = 60

Follow-up rate:396 of 615 (64%) completed 12 mo follow-upCompletion varied by bupropion group: 57% (100 mg), 65% (150 mg), 64% (300 mg), 71% (placebo), p = 0.01Important baseline differences: None between randomized groups; there were important differences between those with and without history of MDD or alcohol dependence (age, gender); however, mean changes in BDI scores did not significantly differ from zero for any groupOutcomes of interest1) Abstinence rate:3 and 12 mo rates (% of randomized)Placebo: 14.4%;12.4%100 mg: 24.2%; 19.6%150 mg: 26.1%; 22.9%300 mg: 29.5%; 23.1%p = 0.01 at 3 mo; p = 0.06 at 12 mo for all 4 groups 150 mg and 300 mg doses statistically significant compared to placebo at all time points12 mo rates for participants with history of MDDPlacebo: 2 of 28 (7%)100 mg: 4 of 28 (14%)150 mg: 5 of 19 (26%)300 mg: 4 of 20 (20%)12 mo rates for participants with history of MDD and alcohol dependencePlacebo: 1 of 3 (33%)100 mg: 2 of 7 (28.6%)150 mg: 4 of 7 (57%)300 mg: 2 of 10 (20%)

General comments:Effect of dose was dependent on diagnosis group Applicability cautions:- Mean age < 45- 96% white- 55% femaleStudy-level quality assessment: GoodComments:- Allocation concealment not specified- Differential followup rate, if dropout, assumed to be smoking and would bias against intervention- Funded by Glaxo Wellcome and included industry investigator(s)Measure of smoking adequate? YesAssessment of adverse effects adequate?Fair; measured depressive symptoms and weight change but little detail on other AE measures
61

moking Cessation Treatments 

Evidence-based Synthesis Program

s, et al., 1999

tions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

2) Medication adherence rate: NR3) Differential effects by gender: NR4) Differential effects by depression status: NR5) Differential effects by treatment sequencing: NAReport adverse effects? YesDiscontinued due to AE: Placebo: 8 (5%)100 mg: 9 (6%)150 mg: 7 (5%)300 mg: 13 (8%)Headache, insomnia*, rhinitis, dry mouth*, and anxiety were most common (* = statistically significantly more)Other:Among those continuously abstinent (n = 103), there was a dose x time interaction (p = 0.04) showing less weight gain as bupropion dose increased
62

moking Cessation Treatments 

Evidence-based Synthesis Program

lo, et al., 1996

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

g + nicotine gum 2 mg 

ing + nicotine gum 4 mg; combined gum (n = 178)ing + placebo (n = 91)

cessation intervention: 

l interventions

brief individual behavioral counseling: behavioral-cog

cedures for coping with urges, cravings and withdrawal 

; help with individual concerns about quitting, such as 

n; no further information given

 gum 2 mg ad lib; target usage of 9-15 pieces/day gum 4 mg ad lib; target usage of 9-15 pieces/day

n intervention: 

tor intervention(s)

cessation intervention: 

l interventions

ntervention group

placebo gum ad lib; target usage of 9-15 pieces/day

n intervention: None

tact time/proportion of sessions completed: NR

t sequencing: NA

Inclusion criteria: - Smoked ≥ 5 cigarettes/day- Good health- Age ≥ 20Exclusion criteria: NRAge: Mean (SD) Overall Depressed40.4 (12.6) 41.6 (12.7)Gender (n [%]):Female  Overall Depressed 145 (51%) 56 (61%)Race/ethnicity (n [%]): White  Overall Depressed 221 (82%) 74 (80%)Black  Overall Depressed 29 (11%) 11 (12%)Other  Overall Depressed 19 (7%) 8 (8%)Baseline depression assessment: CES-D, 20 items, 0-60Smoking characteristics: Mean cigarettes: 22 (10.4)Mean duration: 23.1 yr (4.0)FTND (depressed group): 5.6 (2.4)Comorbid conditions: NR

Follow-up rate: NRImportant baseline differences:NR for intervention groupsDepressed patients were more likely to be female, older, and unmarried than the nondepressedOutcomes of interest1) Abstinence rate:Depressed subgroup (n = 93) at 90 days post–quit date:- Placebo: 4 of 33 (12.5%)- Nicotine gum 2 mg and 4 mg groups: 17 of 59 (29.5%)2) Medication adherence rate:Recommended gum use: 9 to 15 pieces/dayAverage daily gum used for all groups at days 7, 30, 60, 90 was 8.1 pieces, 7.8 pieces, 6.2 pieces, 4.7 pieces, respectively3) Differential effects by gender: NR4) Differential effects by depression status: NR5) Differential effects by treatment sequencing: NAReport adverse effects? - 7 day change in CES-D scores- Placebo group (depressed): no significant change, Tukey p = 0.99- Nicotine group (depressed): lower scores, Tukey p = 0.00003

General comments: NoneApplicability cautions:- Mean age 40- > 50% female- > 80% whiteStudy-level quality assessment: Good Measure of smoking adequate?Atypical definition; less stringent than other studiesAssessment of adverse effects adequate?No; only assessed 7 day change in CES-D scores
63

moking Cessation Treatments 

Evidence-based Synthesis Program

Garvey, 2008

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

 gum, 2-4 mg (collapsed) (n = 405)

gum (n = 203)

cessation intervention: 

l interventions

 brief (5-10 min) counseling at each in-person visit (1, 

60, 90, 180, 270, and 365 days post–quit date)

Clearing the Air” on how to stop smoking was provided 

 2 or 4 mg; groups collapsed across arms as parent 

wed no difference in outcome between groups

n intervention: 

tor intervention(s) 

cessation intervention:

l interventions

 brief (5-10 mi) counseling at each in-person visit

Clearing the Air” on how to stop smoking was provided 

um

n intervention: 

tact time/proportion of sessions completed: NR

t sequencing: NA

Inclusion criteria: - Age ≥ 20- Good health- Smoke ≥ 5 cigarettes/dayExclusion criteria: - Serious medical condition- Use of psychiatric medicationsAge: Mean (SD)- NR for whole population- Depressed 38.5 (11.3)- Nondepressed 41.9 (12.0)Gender (n [%]): Female 312 (51%)Depressed female 110 (56.1%)Nondepressed female 202 (49%)Race/ethnicity (n [%]):  Depressed NondepressedWhite 154 (78.6%) 338 (82%)Black 28 (14.3%) 51(12.4%)Other 14(7.1%) 23 (5.6%)Baseline depression assessment: CES-D, range 0-60; ≥ 16 classified as depressed; 32% depressed at baselineNo information on history of depression or substance abuseSmoking characteristics: - Expired CO > 8 ppm- Number of cigarettes/day - FTNDComorbid conditions (n [%]): Depression 195 (32%) 

Follow-up rate:NR; 3 withdrew for adverse effectsImportant baseline differences:Depressed group was younger, single, and had less education; P < 0.05Outcomes of interest1) Abstinence rate:- At 3 mo:In figure, but numbers not given; would have to extrapolate numbers- At 12 mo:Nondepressed with NRT = 58 of 279 (20.1%)Nondepressed placebo = 20 of 133 (15.1%)Depressed with NRT = 12 of 126 (9.8%)Depressed with placebo = 4/70 (5.7%)2) Medication adherence rate: NR3) Differential effects by gender:NR, but effect of depression no longer significant when adjusted for differences in marital status and education4) Differential effects by depression status: NR5) Differential effects by treatment sequencing: NRReport adverse effects? Yes3 questionable reactions to NRT gum

General comments:Supplemented information using Garvey 2000Applicability cautions:- Majority female- 80% WhiteStudy-level quality assessment: GoodMeasure of smoking adequate? YesAssessment of adverse effects adequate? Yes
64

moking Cessation Treatments 

Evidence-based Synthesis Program

wicz, et al., 2010

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

tine patch + 8 wk CBT (n = 33)

icotine patch + 8 wk CBT + behavioral activation (BA) 

or overall contact time; same specially trained therapists 

ypes of sessions; taped to ensure protocol followed (20% 

cessation intervention: 

l interventions

BT (described in ST below, excluding relaxation; re

h BA)

BA (adapted from Lejuez et al. 2001)

rapy

me 8 wk

on delivered by psychology doctorate-level therapist

s specific to BA included activity monitoring (behav

kout form used for goal setting, planning, and monitor

hout); identifying enjoyable activities and quit-related, 

-maintaining, and relapse-prevention activities

mal nicotine patch for 8 wk from quit date (wk 4) with an 

e of 21 mg for 4 wk, followed by 14 mg for 2 wk, and 7 

wk

ts who smoked on average 10-12 cigarettes/day started 

4-mg patch for the first 6 wk per manufacturer’s recom

ns

n intervention: Nothing additional to BA

Inclusion criteria: - Ages 18 to 65- Smoke ≥ 10 cigarettes/day- Smoke ≥ 1 yr- BDI-II ≥ 10- No current SCID-NP diagnosisExclusion criteria: - BDI ≤ 7- SCID Axis I diagnosis- Current use of psychotropic medications- Current psychotherapy- Contraindication to nicotine patch- Use of smoking pharmacotherapy - Use of other types of tobaccoNote: Demographics were not reported by entire populationAge: Mean (SD) ST BATS  42.6 (11.5) 45.0 (12.2)Gender (n [%]): Female: ST BATS  16 (48.5%) 17 (48.6%)Race/ethnicity (n [%]): African American: ST BATS  25 (75.8%) 24 (69.7%)Baseline depression assessment: BDI, 0-62, score < or > 10: ST BATS  10.4 (7.5) 10.8 (5.2)Smoking characteristics: FTND: ST BATS  6.1 (2.1) 5.8 (1.8)Cigarettes/day: ST BATS  17.3 (8.1) 18.8 (7.1)

Follow-up rate:For abstinence obtained by biochemical verification of smoking status (others considered still smoking):Wk 1 78.6%Wk 4 83.3%Wk 16 61.9%Wk 26 64.3% Important baseline differences:None (see Table 1)Outcomes of interest1) Abstinence rate:  ST BATS ORITT:Wk 16 3/33 4/35 2.71Wk 26 0/33 5/35 ---Completers:Wk 16 6.3 15.4 2.71Wk 26 0.0 19.2 ---Rates decreased over time, but interaction between treatment and time was nsBATS >ST (wk 1-wk 26 post–quit date)abs OR 95% CI p 3.59 (1.22, 3.73) 0.02Continuous abstinence rates did not differ between treatments (p = 0.11)Depression:An interaction between treatment condition and the linear effect of time revealed that the reduction in depressive symptoms over time was greater for BATS than for ST participants (see Table 4, Figure 2)This analysis is in completers (n = 42)BDI beta SE t p -1.99 0.86 -2.31 0.02

General comments: NoneApplicability cautions:Age, gender, race, education and income all similar to veteran populationStudy-level quality assessment: GoodComments:- Repeated measures analyses using GEEs- Random allocation- Blinding not possible- Completers did not differ from ITT by demographicsMeasure of smoking adequate? Yes;only those whose smoking status was biochemically verified were considered abstinent at each time point, whereas the 26 missing participants who dropped out prior to treatment were considered as having smoked in ITT analysesAssessment of adverse effects adequate? NR
65

moking Cessation Treatments 

Evidence-based Synthesis Program

wicz, et al., 2010

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

tor intervention(s)

cessation intervention: 

l interventions

BT

rapy 

me 8 sessions

on delivered by psychology doctorate-level therapist 

s included self-monitoring, identifying effective and in

essation strategies from prior quit attempts, relaxation, 

th triggers, identifying social support for cessation, 

estyle changes (such as increasing physical activity and 

tress), relapse prevention, and homework

me as intervention

n intervention: 

l interventions: None

tact time/proportion of sessions completed: 

16 completed 7 to 8 sessions

 of 26 completed 7 to 8 sessions

t sequencing: NA

es about interventions:

red by Environmental Reward Observation Scale

Comorbid conditions: All were excluded

2) Medication adherence rate:See mean contact time3) Differential effects by gender:NR by treatment 4) Differential effects by depression status:NR by treatment5) Differential effects by treatment sequencing: NAReport adverse effects? No List
66

moking Cessation Treatments 

Evidence-based Synthesis Program

al., 1997

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

moking cessation guide and mood management guide 

e) vs smoking cessation guide and mood management 

mo (delayed)

e vs delayed:

4 MDE) vs n = 65 (52 MDE)

:

ch 2 wk chart up to 6 charts in mood management

ach assessment a 3 mo and 6 mo

aliva sample

cessation intervention: 

l interventions

A” (Guia Para Dejar de Fumar), a 36-page booklet from 

2), is an anti-smoking brochure published in Spanish 

des reasons to quit, preparing to quit, techniques to resist 

o smoke as a result of social situations, and changes in 

xercise to avoid weight gain

nagement intervention, “Tomando Control de Su Vida,” 

assette on how to use materials, 30-minute relaxation 

elf-monitoring of cigarette use booklet, pleasant activity 

 monitoring tool placed to verify receipt of materials and answer ques

ne

n intervention: 

e that we have classified the mood management module 

the smoking cessation intervention, but it could be clas

depression intervention)

tor intervention(s)

cessation intervention: 

l interventions

s delayed (3 mo) mood management; essentially a 

ntrol

ne

n intervention: None

tact time/proportion of sessions completed: NR

t sequencing: NA

Inclusion criteria: - Age 18+ - 3+ cigarettes/day- Completely or very sure they wanted to stop smoking within 3 mo- Able to read Spanish- Have access to audiotape player- Live in Bay areaExclusion criteria: NoneAge: Mean (SD): 35.3, SD = NRGender (n [%]):Women 52 (38.2%)Men 84 (61.8%)Race/ethnicity (n [%]):Latino 136 (100%)Baseline depression assessment: Modified DISCES-D for level of depressive symptomsImmediate: 21.5 (14.9)Delayed: 20.7 (12.5)Lifetime MDE n = 106Current = 53History = 53No MDE history = 30Smoking characteristics: Number of cigarettes/day 14.1 (8.2)Comorbid conditions: NR

Follow-up rate: Not clearly reportedImportant baseline differences:Delayed group had lower education and was less likely to be employedOutcomes of interest1) Abstinence rate:(by self report)Immediate (3 mo)No MDE 4 of 17Current 4 of 28MDE history 8 of 26Immediate (6 mo)No MDE 3 of 17Current 5 of 28MDE history 10 of 26Delayed (3 mo)No MDE 1 of 13Current 3 of 25MDE history 3 of 27Delayed (6 mo)No MDE 2 of 13Current 2 of 25MDE history 2 of 272) Medication adherence rate:Not clearly reportedThose returning filled out materials in immediate group vs those that did not = 45% vs 14% abstinence at 3 mo3) Differential effects by gender: NR 4) Differential effects by depression status:See above for unadjusted results5) Differential effects by treatment sequencing: NAReport adverse effects? NR

General comments:Stratified randomization (no history of MDE vs history of or current MDE)Applicability cautions;Spanish speaking onlyStudy-level quality assessment: FairComments:- Randomization and allocation concealment procedures not well described- No assessment of cotreatments (e.g., NRT)- Follow-up rates not clearly reported- Biochemical verification done, but results not reportedMeasure of smoking adequate? Yes; but not clearly reportedAssessment of adverse effects adequate? NA
67

moking Cessation Treatments 

Evidence-based Synthesis Program

l., 2004

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

dy investigated the addition of fluoxetine to standard 

to improve smoking cessation in smokers with depres

e (20 mg) + NRT + CBT (n = 48)e (40 mg) + NRT + CBT (n = 51)

 NRT + CBT (n = 51)

cessation intervention: 

l interventions

oup CBT started 2 wk prior to quit date delivered by 

erapists with treatment manual; no further information 

f either 20 mg or 40 mg of fluoxetine started 4 wk before f standard (15 mg dose) transdermal NRT started at quit 

 on 15 mg, then 2 wk 10 mg, and 2 wk 5 mg

n intervention: 

l interventions

n addition to standard CBT (fluoxetine is an antidepres

ever)

tor intervention(s)

cessation intervention: 

l interventions

ntervention group

f placebo started 4 wk before quit date 

 transdermal patch NRT as above

n intervention: 

l interventions

ntervention; nothing in addition to standard CBT

tact time/proportion of sessions completed: 

pleted active phase; no difference between groups

t sequencing: NA

Inclusion criteria: - Ages 21 to 65 - ≥ 15 cigarettes/day- Expired CO ≥ 15 ppmExclusion criteria: - Psychiatric episode in last 6 mo- Current psychiatric medication use- Pregnancy- Poor comprehension- Any clinically significant medical conditionAge: Total pop (mean) 39.78SDs NRRange: 21 to 65Placebo 20mg 40mg40.85 40.44 38.44Gender (n [%]): Female:  Placebo 20mg 40mg23 (44.7%) 31(60.8%) 27(56.9%)Race/ethnicity (n [%]): White:Placebo 20mg 40mg78.3% 74.5% 67.3%Black:Placebo 20mg 40mg21.7% 21.3% 26.5%Other:Placebo 20mg 40mg--- 4.2% 6.2%Baseline depression assessment: BDI (mean score):Placebo 20 mg 40 mg6.34 5.14 3.33Smoking characteristics: FTND (score);Placebo 20 mg 40 mg6.13 6.08 5.51Comorbid conditions (n [%]): History of MDD (%)Placebo 20 mg 40 mg17.0% 22.0% 22.0% State-Trait Anxiety (%)Placebo 20 mg 40 mg43.69% 46.29% 44.50%

Follow-up rate:Follow-up rates NR for 3, 6, 12 mo follow-upsImportant baseline differences: Higher BDI in placebo group; F(2,129) = 3.39, p = 0.037 Outcomes of interestAt 15 wk from start of study, smoking cessation = 40%1) Abstinence rate:At 15 wk:Total (n = 150)Placebo = 35.4%20 mg fluoxetine = 43.1% 40 mg fluoxetine = 43.1%History of MDD (n = 30)Placebo = 37.5%20 mg fluoxetine = 54.5%40 mg fluoxetine = 54.5%But these n’s are small ~ 102) Medication adherence: NR3) Differential effects by gender: None4) Differential effects by depression status: None5) Differential effects by treatment sequencing: NAReport adverse effects? Yes; but only that they were lower in both fluoxetine groups compared to placebo (p = 0.038) using the Minnesota Tobacco Withdrawal Symptom Checklist

General comments: Population not depressed (BDI score = 4.92 and only 20% had a history of depression), but results given by whether or not history of MDD was presentSubjects were paid $150 to complete, $25 for follow-up, and $50 at final visitApplicability cautions:College educated, mean = 79.3%Study-level quality assessment: FairComments:- No rates of treatment discontinuation by arm- Selective outcome reporting: Did not report smoking rates by arm across 3, 6, 12 mo follow-ups. - Did not report loss to follow-upMeasure of smoking adequate? Yes; cotinine Assessment of adverse effects adequate?Assessment method not given; reported that number of AEs did not differ between groups
68

moking Cessation Treatments 

Evidence-based Synthesis Program

l., 2009

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

ion description: 

dition of exercise to NRT in a depressed female popula

 smoking abstinence

on: NRT + exercise + smoking cessation behavioral 

g (n = 30)

NRT + health education + smoking cessation behavioral 

g (n = 30)

cessation intervention: 

l interventions

king cessation counseling (10 min/visit) with handouts 

Clearing the Air” brochure via same specialist as CBT 

e

mal patch NRT (21 mg/day) started on quit date (wk 4), 

through wk 10

n intervention: 

l interventions

ial cognitive theory–informed CBT exercise interven

gies (not actual exercise) to encourage patient to meet 

ACSM 1995 guidelines of moderate physical activity 

ay x 5 wk) via trained (manual and observation) patient 

specialist via ten 30 min weekly sessions

luded benefits, goal setting, reinforcement, problem 

vercoming barriers, and relapse prevention 

ctivity was self-monitored.

tor intervention(s)

cessation intervention: 

l interventions

ntervention (above); brief counseling (10 min/visit) with 

via same specialist as health education

me as intervention

n intervention: 

l interventions

e/contact control using health education via patient 

specialist; topics included sleep, nutrition, preventive 

tests

tact time/proportion of sessions completed: 

) sessions completed out of 10 sessions: 

nt Control

8.2(2.7)

Inclusion criteria: - Female- Ages 18 to 65- CES-D ≥ 16- Cigarettes ≥ 10/day for past 6 mo- Current exercise < 20 min on fewer than 3 day/wk- Ability to do exercise- Good health- Negative pregnancy test- BMI ≤ 40Exclusion criteria: - Recent MI- Substance abuse- Psychosis- Nortriptyline, bupropion- Other tobacco product use- Skin allergies or other problems with NRT patch- Suicidal ideationAge: Range: 18 to 65Mean (SD):  Treatment Control 40.9 (11.8) 41.8 (12.1)Gender (n [%]):Female 60 (100%) Race/ethnicity (n [%]): White 59 (98%) - Black 1 (2%) in exercise group- White 30 (100%) in control groupBaseline depression assessment: CES-D, 0-60, > 16 Treatment Control 29.8(9.3) 32.4(9.6)HRSD Treatment Control 12.8(6.0) 15.4(9.3)

There were no significant differences between groups on any outcome variableFollow-up rate:Wk 24 follow-up: Treatment Control 16 of 30 (53%) 15 of 30 (50%)Important baseline differences:Current psychotherapy: Treatment Control 7 (23) 11 (37)Current pharmacotherapy Treatment Control 16 (53) 19 (63)Outcomes of interest 1) Abstinences rate:Wk 24 follow-up Treatment Control 1 of 16 (6.3%) 1 of 15 (6.7%)2) Medication adherence rate:NRT: Treatment Control 36% 31%Exercise or Education: Treatment Control 49% 21%3) Differential effects by gender: NA (all female)4) Differential effects by depression status: NR5) Differential effects by treatment sequencing: NAReport adverse effects? No

General comments:Subjects were paid a nominal fee: $25 at end of treatment (wk 10) and $25 after follow-up (wk 24)Applicability cautions:- 65% college-educated- 100% overweight white femalesStudy-level quality assessment: Fair to poorComments:- Small pilot, not powered for any statistical test stronger than analysis via 2 sample, rank-sum test - In the exercise literature, not helping overweight people with the actual exercise has been shown to be of no benefit- Missing outcome data on 50% of sample by wk24Measure of smoking adequate? YesAssessment of adverse effects adequate? NR
69

moking Cessation Treatments 

Evidence-based Synthesis Program

l., 2009

ions Participant Characteristics Results and Adverse Effects

Comments/Quality Scoring

t sequencing: NA

es about interventions:

nt to note that subjects were left on their own to find 

d types of actual exercise

asured weight, weight concerns, change in mood (Posi

egative Affect Scale), fitness level (VO2 max test), and 

ctivity (physical activity recall)

Smoking characteristics: Cigarettes/day: Treatment Control 20.0 (7.8) 21.6 (7.3)FTND score ≥ 6 Treatment Control 16 (53) 20 (67)Comorbid conditions (n [%]):None medical or psychiatric; all excluded but examined weight concern: Treatment Control 5.8 (2.2%) 6.6 (2.1%)Weight, kg: Treatment Control 76.0 (15.1%) 73.6 (15.7%)

m = ante meridian (before noon), BA = behavioral activation, BATS = behavioral activation treatment for smoking, BDI-II = Beck Depression Inventory-II, BID 

ehavioral therapy, CES-D = Center for Epidemiologic Studies-Depression Scale, CI = confidence interval, CO = carbon monoxide, DIS = Diagnostic Interview 

Nicotine Dependence, GEE = generalized estimating equation, HDRS = Hamilton Depression Rating Scale, ID = identification, ITT = intention to treat, MDD 

ajor depressive episode, mg = milligram or milligrams, ml = milliliter, mo = month/months, n = number, NA = not applicable, NCI = National Cancer Institute, 

T = nicotine replacement therapy, ns = not significant, OR = odds ratio, p = probability, pm = post meridian (afternoon), POMS = Profile of Mood States, ppm = 

ntrolled trial, SCID = Structured Clinical Interview for DSM Diagnoses, SD = standard deviation, SE = standard error, ST = standard treatment, UDD = unipo

= week/weeks, yr = year/years
70

Comparative Effectiveness of Smoking Cessation Treatments 

for Patients With Depression Evidence-based Synthesis Program

LIST OF INCLUDED STUDIES IN ALPHABETICAL ORDER

Brown RA, Kahler CW, Niaura R, et al. Cognitive-behavioral treatment for depression in smoking cessation. J Consult Clin Psychol 2001;69(3):471-80.

Covey LS, Glassman AH, Stetner F. Naltrexone effects on short-term and long-term smoking 

cessation. J Addict Dis 1999;18(1):31-40.

Covey LS, Glassman AH, Stetner F, et al. A randomized trial of sertraline as a cessation aid for 

smokers with a history of major depression. Am J Psychiatry 2002;159(10):1731-7.

Duffy SA, Ronis DL, Valenstein M, et al. A tailored smoking, alcohol, and depression intervention for head and neck cancer patients. Cancer Epidemiol Biomarkers Prev 2006;15(11):2203-8.

Evins AE, Culhane MA, Alpert JE, et al. A controlled trial of bupropion added to nicotine patch 

and behavioral therapy for smoking cessation in adults with unipolar depressive disorders. J Clin 

Psychopharmacol 2008;28(6):660-6.

Hall SM, Munoz RF, Reus VI. Cognitive-behavioral intervention increases abstinence rates for 

depressive-history smokers. J Consult Clin Psychol 1994;62(1):141-6.

Hall SM, Munoz RF, Reus VI, et al. Mood management and nicotine gum in smoking treatment: 

a therapeutic contact and placebo-controlled study. J Consult Clin Psychol 1996;64(5):1003-9.

Hall SM, Reus VI, Munoz RF, et al. Nortriptyline and cognitive-behavioral therapy in the treatment of cigarette smoking. Arch Gen Psychiatry 1998;55(8):683-90.

Hall SM, Tsoh JY, Prochaska JJ, et al. Treatment for cigarette smoking among depressed mental 

health outpatients: a randomized clinical trial. Am J Public Health 2006;96(10):1808-14.

Hayford KE, Patten CA, Rummans TA, et al. Efficacy of bupropion for smoking cessation in 

smokers with a former history of major depression or alcoholism. Br J Psychiatry 1999;174:173-8.

Kinnunen T, Doherty K, Militello FS, et al. Depression and smoking cessation: characteristics of 

depressed smokers and effects of nicotine replacement. J Consult Clin Psychol 1996;64(4):791-8.

Kinnunen T, Korhonen T, Garvey AJ. Role of nicotine gum and pretreatment depressive symptoms in smoking cessation: twelve-month results of a randomized placebo controlled trial. Int J 

Psychiatry Med 2008;38(3):373-89.

MacPherson L, Tull MT, Matusiewicz AK, et al. Randomized controlled trial of behavioral activation smoking cessation treatment for smokers with elevated depressive symptoms. J Consult 

Clin Psychol 2010;78(1):55-61.

Munoz RF, Marin BV, Posner SF, et al. Mood management mail intervention increases abstinence rates for Spanish-speaking Latino smokers. Am J Community Psychol 1997;25(3):325-43.

Saules KK, Schuh LM, Arfken CL, et al. Double-blind placebo-controlled trial of fluoxetine in 

smoking cessation treatment including nicotine patch and cognitive-behavioral group therapy. 

Am J Addict 2004;13(5):438-46.

Vickers KS, Patten CA, Lewis BA, et al. Feasibility of an exercise counseling intervention for 

depressed women smokers. Nicotine Tob Res 2009;11(8):985-95.
71

moking Cessation Treatments 

Evidence-based Synthesis Program

LUDED STUDIES 

were reviewed in their full-text version and excluded for the reason indicated. An alphabetical reference list follows the 

dies

pulation

depressed

Main outcome not 

of interest to key 

questions

Not peer-reviewed Main outcome not 

reported at desired 

interval

Not RCT or 

secondary analysis

Analysis does 

not address key 

questions

X

X

X

X

X

X

XX

X

XXXX

X

X

X

X

X

X

XX

X

X
72

moking Cessation Treatments 

Evidence-based Synthesis Program

pulation

depressed

Main outcome not 

of interest to key 

questions

Not peer-reviewed Main outcome not 

reported at desired 

interval

Not RCT or 

secondary analysis

Analysis does 

not address key 

questions

XX

X

X

X

X

X

X

X

X

XXXXX XX

X

X

X X

X

X

XXX

X

X

X

X

X
73

moking Cessation Treatments 

Evidence-based Synthesis Program

pulation

depressed

Main outcome not 

of interest to key 

questions

Not peer-reviewed Main outcome not 

reported at desired 

interval

Not RCT or 

secondary analysis

Analysis does 

not address key 

questions

X

XX

X

X

X

XX

X

X

XXXXXX

X

XX

X

XX
74

Comparative Effectiveness of Smoking Cessation Treatments 

for Patients With Depression Evidence-based Synthesis Program

LIST OF EXCLUDED STUDIES 

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Alderton W, Karran E, Ward S. Current and Future Perspectives in Psychiatric Drug Discovery. 

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APPENDIX E: ACRONYMS AND ABBREVIATIONS

AE adverse effects

am ante meridian (before noon)

BA behavioral activation

BATS behavioral activation treatment for smoking

BID two times per day

BDI-II Beck Depression Inventory-II

CBT cognitive behavioral therapy

CES-D Center for Epidemiologic Studies-Depression

CI confidence interval

CO carbon monoxide

DIS Diagnostic Interview Schedule

FTQ Fagerstrom Tolerance Questionnaire

FTND Fagerstrom Test for Nicotine Dependence

GEE generalized estimating equation

ID identification

HDRS Hamilton Depression Rating Scale

ITT intention to treat

MDD major depressive disorder

MDE major depressive episode

mg milligram or milligrams

mo month or months

ml milliliter or milliliters

N or n number

NA not applicable

NCI National Cancer Institute

ng nanogram

NRT nicotine replacement therapy

NR not reported

ns or NS not significant

OR odds ratio

p probability

pm post meridian (after noon)

POMS Profile of Mood States

ppm parts per million

RCT randomized controlled trial

SCID Structured Clinical Interview for DSM Diagnoses

SD standard deviation

SE standard error

ST standard treatment

UDD unipolar depressive disorder

vs versus

wk week or weeks

yr year or years