Clinical trial NCT02245308
Conditions: Tobacco Use Disorder Homelessness
Keywords: Tobacco use cessation Homelessness Veterans
Sponsor: VA Office of Research and Development
Start date: 2014-10-01; Completion date: 2018-09-28
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this research study is to examine the effects of a treatment for helping homeless veterans who smoke to stop smoking. Participants in the study will be assigned to one of two study groups. Participants in the first group will be referred to the local Department of Veterans Affairs Medical Center's Smoking Cessation Clinic for treatment. Second group participants will receive a behavioral treatment designed to reward smokers for quitting and staying quit. These participants will also receive telephone counseling and medications for smoking cessation.

Detailed description:
Cigarette smoking is the most lethal substance use disorder in the United States in terms of morbidity and mortality. Veterans who are homeless, along with those who have mental health or substance abuse problems, are at the highest risk for nicotine dependence. Prevalence estimates for smoking among homeless Veterans are 80%. Thus, homeless Veterans are at tremendous risk for smoking related morbidity and mortality. This information suggests that smoking needs to be targeted specifically among this high risk population of smokers.

The addition of contingency management (CM) to existing evidence-based tele-health smoking cessation interventions is expected to be a cost-effective way to increase the reach of intensive smoking cessation treatment. CM is a behavioral therapy that provides positive reinforcers to individuals misusing substances contingent upon objective evidence of abstinence from substance use. Because CM requires verification of abstinence multiple times daily with a clinic-based carbon monoxide (CO) monitor, it has largely been relegated to inpatient and day treatment programs. The application of emerging smart phone technology, however, can overcome this barrier, and may be particularly well suited to homeless Veterans. The innovative smart phone application has made the use of CM for outpatient smoking cessation portable and feasible. The goal of this comparative effectiveness trial is to evaluate the effectiveness of a combined tele-health and mobile CM intervention that the investigators are calling Abstinence Reinforcement Therapy (ART). The investigators propose to screen 165 and randomize 126 homeless Veteran smokers to either:

ABSTINENCE REINFORCEMENT THERAPY (ART), a tele-health intervention that combines guideline-based cognitive-behavioral telephone (CBT) counseling, a tele-medicine clinic for access to smoking cessation aids including choice of pharmacotherapy, and intensive behavioral therapy through mCM.

VA SPECIALTY SMOKING CESSATION TREATMENT control, which includes all the elements associated with enrollment in a VA specialty smoking cessation clinic including group counseling, individual telephone counseling, self-help materials, and smoking cessation aids including choice of pharmacotherapy.

Specific aims are to:

AIM 1: Evaluate the impact of ART on rates of abstinence from cigarettes as measured by bio-verified, self-reported prolonged abstinence at post-treatment, and 3-month and 6-month post-randomization follow-ups.

AIM 2: Evaluate the relative cost-effectiveness of the ART intervention in quality adjusted life years (QALY).

AIM 3: Evaluate potential treatment mediators including self-efficacy-related mechanisms.

Supplementary AIM: To evaluate the impact of psychiatric (i.e., PTSD, depression and alcohol abuse) symptoms on treatment outcome across the two conditions.

Arms: arm 1: Participants assigned to this treatment arm will receive a tele-health intervention that combines guideline-based cognitive-behavioral counseling for smoking cessation, a tele-medicine clinic for access to smoking cessation aids, and an intensive behavioral therapy for smoking cessation called mobile contingency management. arm 2: Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
Interventions: intervention 1: Nicotine Patches intervention 2: mobile contingency management (mCM) intervention 3: Smoking cessation counseling intervention 4: Nicotine rescue method intervention 5: Bupropion
Intervention descriptions: intervention 1: Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date. Nicotine patches may be provided to control group participants as part of usual care. intervention 2: Mobile contingency management (mCM) is a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings. Any time a participant uploads a video recording that suggests abstinence (i.e., low CO reading), he/she will be provided a monetary reward. intervention 3: Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. intervention 4: Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date. Nicotine gum or lozenges may be provided to control group participants as part of usual care. intervention 5: Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date. Bupropion may also be prescribed to control group participants as part of usual care.

Protocol documents:
Prot_SAP_000.pdf: 
Protocol, PI version date 7/21/17  
1 
Research Protocol: Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers 
Principal Investigator: Jean C. Beckham, Ph.D. 
 
Cigarette smoking is the most lethal substance use disorder in the United States in terms of morbidity and 
mortality (Centers for Disease Control and Prevention, 2008, Mokdad, et al., 2004). Unfortunately, smoking 
cessation treatment including smoking cessation aids such as nicotine replacement therapy (NRT) are greatly 
underutilized (National Institute of Health, 2006). Veterans who are homeless, along with those who have 
mental health or substance abuse problems, are at the highest risk for nicotine dependence (Tsai, et al., 2011). 
Prevalence estimates for smoking among homeless Veterans are 80% (Tsai & Rosenheck, 2012). Thus, 
homeless Veterans are at tremendous risk for smoking related morbidity and mortality.  
 
Risks associated with smoking among homeless Veterans are also increased because of the high rates of HIV 
prevalence among persons who are homeless (Reynolds, 2009; Robertson et al., 2004; Culhane et al., 2001) 
and homeless Veterans specifically (100,000 Homes, 2011). Evidence suggests that there are substantial health 
implications for smoking among persons living with HIV/AIDS (PLWHA; Reynolds, 2009). For example, PLWHA 
who smoke compared to those who don’t smoke are at increased risk of developing an AIDS-related condition 
(Crothers et al., 2005). To our knowledge, the impact of smoking cessation on disease progression among 
homeless Veterans who are living with HIV/AIDS has not been examined.  
 
Smoking cessation efforts among homeless Veterans to date have been largely ineffective. Even among 754 
homeless Veterans enrolled in mental health, primary care and supported housing at 11 U.S. sites (3/4 of 
whom had discussed their smoking with a health care professional), smoking was not decreased over a one 
year period. Taken together, this information suggests that smoking needs to be targeted specifically among 
this high risk population of smokers (Tsai & Rosenheck, 2012).  
 
The addition of contingency management (CM) to existing evidence-based tele-health smoking cessation 
interventions is expected to be a cost-effective way to increase the reach of intensive smoking cessation 
treatment. CM is a behavioral therapy that provides positive reinforcers (e.g., money, vouchers) to individuals 
misusing substances contingent upon objective evidence of abstinence from drug use. Implementation of CM 
has been limited because of the need to verify abstinence multiple times daily with a clinic-based carbon 
monoxide (CO) monitor. As a result, CM has largely been relegated to inpatient and day treatment programs. 
The application of emerging smart phone technology, however, can overcome this barrier, and may be 
particularly well suited to homeless Veterans, most of who use cell phones. We have developed a smart phone 
application which allows a participant to video themselves several times daily while using a small CO monitor 
and to transmit the data to a secure server. This innovation has made the use of CM for outpatient smoking 
cessation portable and feasible, i.e., mobile CM (mCM). The goal of the current study is to evaluate the 
effectiveness of a combined tele-health and mCM intervention that we are calling Abstinence Reinforcement 
Therapy (ART). Proposed is a comparative effectiveness trial with a two-group design in which 165 homeless 
Veteran smokers will be screened and 126 will be randomized to either: 
 
ABSTINENCE REINFORCEMENT THERAPY (ART), a tele-health intervention that combines guideline-based 
cognitive-behavioral telephone (CBT) counseling, a tele-medicine clinic for access to smoking cessation 
aids including choice of pharmacotherapy, and intensive behavioral therapy through mCM. 
 
VA SPECIALTY SMOKING CESSATION TREATMENT control, which includes all the elements associated with 
enrollment in a VA specialty smoking cessation clinic including group counseling, individual telephone 
counseling, self-help materials, and smoking cessation aids including choice of pharmacotherapy. 


Protocol, PI version date 7/21/17  
2 
 
Both of the proposed interventions are designed in accordance with national smoking cessation guidelines. 
Tele-health smoking cessation interventions are typically less intensive than clinic-based specialty care, but 
increase reach of services through bypassing barriers to participation such as transportation. The addition of 
mCM to an evidence-based tele-health smoking intervention will significantly increase the intensity of the 
intervention and is predicted to increase efficacy. If cessation programs are to have significant impact (Impact 
= Reach X Efficacy) (Abrams, et al., 1996) on changing health behavior at the population level, we must 
identify new and innovative strategies to increase treatment intensity, access, and participation. Specific aims 
are to: 
 
AIM 1: Evaluate the impact of ART on rates of abstinence from cigarettes as measured by bio-verified, self-
reported prolonged abstinence at post-treatment, and 3-month, 6-month, and 12-month post-randomization 
follow-ups. 
Hypothesis 1: Abstinence rates will be significantly higher among homeless Veterans randomized to the 
ART intervention than among those randomized to the VA specialty smoking cessation intervention 
(primary end-point will be self-reported and bio-verified prolonged abstinence at the 6-month follow-up). 
 
AIM 2: Evaluate the relative cost-effectiveness of the ART intervention in quality adjusted life years (QALY). 
Hypothesis 2: ART will result in greater cost-effectiveness compared to the control condition as measured 
by the incremental cost-effectiveness ratio. 
 
AIM 3: Evaluate potential treatment mediators including self-efficacy-related mechanisms. 
Hypothesis 3: Increased abstinence associated with ART will be partially mediated by increased self-
efficacy compared to the VA specialty smoking cessation care condition. 
 
Supplementary AIM 1: To evaluate the impact of psychiatric (i.e., PTSD, depression and alcohol abuse) 
symptoms on treatment outcome across the two conditions. 
 
Supplementary AIM 2: To evaluate the impact of smoking status on HIV disease progression (presence of 
AIDS-related illnesses) and disease progression markers (CD4 T-cell count, viral load). 
 
The funding source for the study is a VA Rehabilitation Research and Development Merit Review awarded to 
Dr. Jean Beckham. Portions of the salaries of Dr. Beckham’s study team are funded by this grant. 
 
METHODS 
 
Participants 
We anticipate consenting and screening 165 homeless male and female adult Veterans in order to reach our 
goal of randomizing 126 participants. Based on the following conservative assumptions, we expect to be able 
to recruit approximately 165 Veterans in the 36 month enrollment period; we anticipate more than 35 screen 
outs at the screening visit. There are currently over 67,000 Veterans enrolled at the Durham VAMC and 
approximately 33% of these Veterans are current smokers. There are currently at least 1,231 homeless 
Veterans with co-morbid nicotine dependence enrolled at the DVAMC. If we enroll only 11% of eligible 
homeless smokers we expect to achieve our recruitment goal of 126 eligible Veterans within a 36 months 
recruitment window. Based on our previous studies, we expect that 10-15% of our participants will be female, 
and 40% will be minorities. See Table 1 for a summary of the study’s inclusion and exclusion criteria. 
 


Protocol, PI version date 7/21/17  
3 
 
Table 1. Inclusion/Exclusion Criteria 
Veterans must meet all inclusion criteria: 
Veterans who meet any one of the exclusion criteria 
will be excluded:               
• 
Homeless 
• 
Enrolled in the Durham VA for ongoing care 
• 
Current smokers (at least 10 cigarettes or 
equivalent daily) 
• 
Willing to quit smoking in the next 30 days 
 
• 
Has current uncontrolled substance use 
disorder (other than nicotine dependence) that 
would interfere with his/her ability to perform 
study procedures 
• 
Uncontrolled psychotic symptoms  
• 
Severely impaired hearing or speech (Veterans 
must be able to respond to phone calls.) 
• 
Lack of interest in participating in telephone 
care 
• 
Pregnancy 
 
There are multiple competing definitions for “homeless.” We will use the definition followed in the most 
recent VA congressional report (Perl, 2012) that defines homelessness as one of the following: 1) living in a 
shelter; 2) living in an institution that provides temporary residence; 3) a public or private place not designed 
for regular sleeping accommodation for human beings; 4) imminent loss of housing; and 5) other federal 
definitions including a) experienced a long term period without permanent house; b) instability as evidenced 
by frequent moves; or c) can be expected to continue in unstable housing due to factors such as chronic 
disabilities. 
 
Recruitment 
Study staff will identify potential eligible Veterans using several different means. First, potentially eligible 
Veterans may be identified through data pulls from DVAMC’s electronic medical record using Fileman. The 
study staff will also work closely with staff in the DVAMC’s Healthcare for Homeless Veterans program to 
identify potentially eligible Veterans. Flyers, informational business cards and brochures that have been 
approved by DVAMC’s Institutional Review Board (IRB) will be posted on research bulletin boards, program 
offices, and clinic areas, including the VA’s Infectious Disease Clinic. In addition, study staff members will visit 
local housing facilities (e.g., shelters, transitional housing developments) to identify potential participants, and 
flyers and brochures will be placed in those community settings. We will also advertise via the closed circuit 
television system within the VA Medical Center. We will post ads in local newspapers and online classified 
advertisement services, including Craigslist.com. Also, upon approval from the Public Affairs officer, we will 
host informational tables in the medical center. At these informational tables, IRB-approved recruitment 
materials from the study (and from other studies run in the Traumatic Stress and Health Research Laboratory) 
will be made available to interested veterans, and study staff members may be on site to answer questions 
about the research studies. No participants will be consented or screened at these public locations. 
 
If a Veteran is identified from the electronic medical record, he/she will be sent an introductory letter signed 
by the PI that describes the study and informs them that they will be called or contacted regarding 
participation. If the electronic medical record reveals that the Veteran has an upcoming appointment at the 
medical center, that Veteran will be sent a special letter indicating that the study coordinator may be available 
to meet them at their scheduled appointment. The study coordinator will contact via encrypted email the 
scheduled provider to notify the provider that the Veteran is potentially eligible, and ask him/her to mention 
the study and provide basic information (if willing). The clinician will be asked to introduce the potentially 
eligible Veteran to the study coordinator in person. The study coordinator would then describe the study, 


Protocol, PI version date 7/21/17  
4 
stress the voluntary nature of the study, and if possible, determine basic eligibility using the IRB-approved 
telephone screen. If a clinician does not wish to assist recruitment in this manner, he/she will also be given the 
option of providing a direct referral via a paper form; see following paragraph. If the clinician indicates 
unwillingness to assist with recruitment, the study coordinator will not solicit help from him/her. In both 
versions of the recruitment letter, potential participants will be given an “opt-out” number to call in order to 
decline participation and/or further contact regarding participation. Study staff members will perform random 
spot-checks of names and addresses on 20% of all letters prior to mailing. This will capture any sorting error 
that may have occurred during the preparatory procedures. Seven business days after the mailing, Veterans 
who have not called the toll free number to decline participation may be called by a study staff member to 
request their participation in the research study. In the telephone contact, the study staff member will inform 
the Veteran that he/she was contacted for recruitment because he/she is a homeless Veteran who smokes 
and is registered for care at DVAMC. Any Veteran who contacts or is contacted by study staff will be told that 
their participation is voluntary, and they may choose not to answer any questions that they find too sensitive. 
Also, Veterans will be told that their participation will not affect their care at the VA. The study staff member 
will explain the study in detail, including compensation. No study procedures will begin until formal, written 
informed consent has been obtained. 
 
Because Traumatic Stress and Health Research Laboratory has many studies that are currently enrolling 
participants, we will utilize a centralized recruitment strategy in order to “triage” participants into the correct 
studies. We have created a centralized recruitment phone screen and flowchart that reflects our current 
studies. When any potential participant contacts our centralized recruitment telephone number, the study 
team member answering the VA phone line will use the centralized phone screen to determine potential 
eligibility. The study team member will then pass along any potential participants’ information to the study 
coordinator for the appropriate study. That study coordinator will use his/her study-specific phone script to 
further determine eligibility.  
 
In conversations with clinicians from several clinics in DVAMC, we have been provided the feedback that they 
strongly prefer to provide potential participants’ names and contact information. Clinicians have reported that 
they Veterans often indicate that they prefer that their names and contact information be provided directly to 
study staff.  We’d like to make it easy for interested Veterans to get involved in research, while protected the 
privacy of those Veterans who are not interested in research. Towards that end, we have developed a system 
whereby clinicians can more directly identify potentially eligible participants. We will ask that the clinician or 
provider provide basic information about the study to potentially eligible Veterans; clinicians will be provided 
IRB-approved recruitment materials to assist this patient education. If the Veteran is interested in learning 
more about participation, the clinician or provider will provide a “Contact Me” information sheet to the 
Veteran for him/her to complete. We will request that all “Contact Me” sheets will be completed by the 
Veteran, not by the provider. The information sheet includes options for contact by the study staff (e.g., send 
me information, call me, send me information and call me). If any Veteran prefers to receive information by 
mail, he/she will be sent the IRB-approved recruitment letter. Any Veteran who prefers to receive information 
by phone will be contacted using the IRB-approved telephone script. This information sheet will provide 
“…written documentation that the subject is willing to be contacted by telephone about the study,” as 
outlined in VHA Handbook 1200.5. “Contact Me” sheets will be delivered to study staff members via secured 
means (e.g., internal VA snail mail, encrypted Outlook emails with pdf attachments, personal delivery). Any 
sheets sent via internal VA mail will be placed inside a sealed and addressed envelope that is THEN put into 
the snail mail envelope. This plan has been reviewed with local privacy and information security officers. 
Similar to VA consults, if any clinician finds use of the “Contact Me” sheets to be too onerous, he/she can refer 


Protocol, PI version date 7/21/17  
5 
a participant directly to our clinic by adding the study PI or study coordinator as a co-signer to a note in CPRS 
in which the clinician has documented that the participant wishes to be contacted about participation.  
 
In order to reach a wider range of homeless Veterans, we will plan to use a recruitment method referred to as 
respondent-driven sampling, or “seed recruitment” (Christina Meade, Ph.D., personal communication). Seed 
recruitment is suitable for sampling “hidden populations” of participants who are best known by their own 
peers (Heckathorn, 1997).  It includes providing incentives to participants for referral of other eligible 
participants. In our model, each participant, or seed, will receive six coupons to recruit other Veterans in 
his/her social networks. The recruitment coupons will provide a brief description of the survey and a phone 
number for contacting the study coordinator. The coupon will be marked with a unique identification number 
(not the study identification number) so that when the coupons are returned to us, the ID number can be used 
to provide a small payment ($25) to the participant who made the referral. The key connecting the 
participant’s study ID number with the seed ID number will be kept in a database separate from other PHI, 
creating two layers of separation between the seed ID and the already-participating Veterans’ identifying 
information. Any Veteran who does not wish to recruit in this manner will not be required to do so. 
 
There is evidence suggesting that research study branding may be helpful for recruitment and retention of 
research participants, especially those with low incomes (Nicholson et al., 2011). In order to enhance 
recruitment and retention, we’d like to use branded recruitment materials and provide branded materials to 
participants. Branded materials may include banners, tote bags, and plastic bracelets. Of course, any 
participant who does not wish to use the branded materials such as the tote bag will not be required to do so.  
 
Study Procedures 
Table 2 depicts a summary of study procedures for control group participants; Table 3 depicts a summary of 
study procedures for 
ART group participants. 
 
Session 1. All 
participants will 
complete an initial 
screening visit. At the 
beginning of the visit 
lasting approximately 
five hours, participants 
will meet with a senior 
staff member. The study 
will be explained in 
detail and informed 
consent with HIPAA 
authorization will be 
obtained. The 
participant will then 
provide a breath sample 
in order to assess CO 
level. Urine will be 
collected for drug 
screening to corroborate participants’ self report. Because a substance use disorder that would impact ability 
Table 2. Control Group Study Procedures 
Session 
Tasks 
Time 
Payment 
1 (lab) 
• 
Consent 
• 
Screening (clinical interview, 
questionnaires) 
• 
Urine sample, breath sample taken 
• 
Referral to VA specialty smoking cessation 
• 
Seed recruitment coupon distribution 
30 min 
3.5 to 4 
hours 
$50 
 
 
 
$10 for coupon 
return 
7 (phone; 
about 9 
weeks after 
enrollment) 
• 
Quick phone check-in 
 
10 min 
None 
8 (lab; 3 
month 
follow-up) 
• 
Questionnaires 
• 
Saliva sample & urine drug screen 
requested 
20 min 
$25 for survey; $75 
for returned saliva 
sample; potentially 
$100 for 
abstinence   
9 (phone; 6 
month 
follow-up) 
• 
Questionnaires 
• 
Saliva sample & urine drug screen 
requested 
20 min 
$25 for survey; $75 
for returned saliva 
sample  
10 (phone; 
12 month 
follow-up) 
• 
Questionnaires 
• 
Saliva  sample & urine drug screen 
requested 
20 min 
$25 for survey; $75 
for returned saliva 
sample 
 
 
TOTAL 
Up to $460 


Protocol, PI version date 7/21/17  
6 
to participate in study 
procedures, not any drug 
use, is an exclusion criterion 
for this study, any 
participant whose urine drug 
screen is positive will not 
necessarily be excluded from 
participation. Exclusion will 
be based 
on psychiatric interview 
results, with drug screen 
results serving as 
corroborating evidence for 
reported abstinence where 
applicable. Any woman who 
is of child-bearing age 
and/or potential will be 
given a urine pregnancy test. 
Pregnant women will be 
excluded from participation. 
 
Participants who continue to 
be potentially eligible will be 
interviewed using the 
Structured Clinical Interview 
for DSM IV Diagnosis (SCID; 
First, Spitzer, Gibbon, & 
Williams, 1994) in order to 
further determine 
participant eligibility. If 
during the SCID interview a 
participant endorses risk for 
suicidal or homicidal 
ideation, staff members will 
follow policy set out in the 
Traumatic Stress and Health 
Research Laboratory’s 
Psychiatric Emergency 
Standards of Practice. 
 
Participants will meet with a study staff member to complete study measures using a REDCap survey in which 
participants are “interviewed” for survey answers. We have chosen this method of collection of baseline 
measures because it most closely matches the collection of questionnaire data in the telephone follow-up 
sessions. The baseline survey will include the following measures: 
 
Table 3. ART Group Study Procedures 
Session 
Tasks 
Time 
Payment 
1 (lab) 
• 
Consent 
• 
Screening (clinical interview, 
questionnaires) 
• 
Urine sample, breath sample taken 
• 
Seed recruitment coupon distribution 
30 min 
4-4.5 hours 
$50 
 
 
$10 for coupon 
return 
2 (phone) 
• 
Counseling session 1 
• 
Set target quit date (midnight before 
session 4) 
30 mins. 
None 
Training 
call 
(phone) 
• 
mCM equipment training 
15 mins 
None 
3 (phone) 
• 
Counseling session 2 
• 
Begin practice mCM for 1 week 
• 
Begin bupropion if using 
30 mins. 
Up to $14 for 
monitoring 
between 3 & 4 
4 (phone) 
 
• 
Quit day 
• 
Counseling session 3 
• 
Begin abstinence mCM 
• 
Begin NRT  
30 mins. 
Up to $132.50 for 
monitoring 
between 4 & 5 
5 (phone; 2 
wks post 
session 4) 
• 
Counseling session 4 
• 
Continue abstinence mCM 
• 
Reduce NRT to 14 mg 
• 
Continue use of “rescue” NRT PRN 
30 mins. 
Up to $333.50 for 
monitoring 
between 5 & 6 
6 (phone; 2 
wks post 
session 5) 
• 
Counseling session 5 
• 
Continue mCM wash-out period  
• 
Reduce NRT to 7 mg  
• 
Continue use of “rescue” NRT PRN 
10 min 
Up to $48 for 
monitoring 
between 6 & 7 
7 (phone; 2 
wks post 
session 6) 
• 
Quick phone check-in 
• 
Prompt to return equipment  
• 
Cease NRT 
10 min 
$50 for returned 
equipment 
8 (lab ; 3 
month 
follow-up) 
• 
Questionnaires 
• 
Saliva sample & urine drug screen 
requested 
20 min 
$25 for survey; 
$75 for returned 
saliva sample; 
potentially $100 
for abstinence   
9 (phone 
and/or lab; 
6 month 
follow-up) 
• 
Questionnaires 
• 
Saliva sample & urine drug screen 
requested 
 
20 min 
$25 for survey; 
$75 for returned 
saliva sample 
10 (phone 
and/or lab; 
12 month 
follow-up) 
• 
Questionnaires 
• 
Saliva sample & urine drug screen 
requested 
 
20 min 
$25 for survey; 
$75 for returned 
saliva sample 
 
 
TOTAL 
Up to $1038  


Protocol, PI version date 7/21/17  
7 
1. A demographics measure inquiring about age, race, gender, marital status, education, employment 
status, travel time, cell and smart phone use, and homelessness status/definition information (Perl, 
2012); 
2. The Fagerström Test of Nicotine Dependence [FTND; (Heatherton, et al., 1991)] and a general smoking 
history questionnaire (e.g., number of cigarettes smoked/day, age of first smoking, living with a 
smoker); 
3. A brief checklist asking about contraindications to NRT and bupropion;  
4. PTSD Checklist for DSM-5 [PCL-5; (Weathers, et al., 2013)]; 
5. Patient Health Questionnaire [PHQ-9; (Spitzer, et al., 1999)]; 
6. Three-item AUDIT-C (Bush, et al., 1998);  
7. A single item to assess global self-efficacy to quit smoking: “How confident are you that you will be 
able to quit smoking?” [1= Not at all confident to 4= Very confident; (Shiffman, et al., 2000)];  
8. Quality of life will be measured using the EuroQol 5D (The EuroQol Group, 1990). The EuroQol includes 
questions designed to measure quality of life across five domains: mobility, self care, usual activities, 
pain/discomfort, and anxiety/depression. This measure is required for computing quality-adjusted life 
years. 
9. Several questions designed to measure electronic cigarette use;  
10. Several questions designed to evaluate efficacy of CO readings and recording as an indication of 
abstinence (at 3-month follow-up only); 
11. The Smoking Abstinence Questionnaire (Hendricks et al., 2011), which is a measure of expectancies 
related to quitting smoking;  
12. An alcohol use assessment designed by National Institute on Alcohol Abuse and Alcoholism (NIAAA; 
from http://www.niaaa.nih.gov/research/guidelines-and-resources/recommended-alcohol-questions;  
13. A marijuana use measure, including items related to marijuana smoking history (Bonn-Miller & 
Zvolensky, 2005) and motives for marijuana use (Simons, Correia, Carey, & Borsari, 1998);  
14. A mobile technology use questionnaire (Erbes et al., 2014) that has been modified to include questions 
regarding texting;   
15. The revised Helping Alliance Questionnaire (HAQ), which measures participant alliance with the 
therapy and the individual therapist. Therapeutic alliance has been shown to be an important 
construct that predicts positive outcome in therapy (Horvath & Luborsky, 1993); 
16. The Role Functioning Scale, which measures adult functioning in four domains: working productivity, 
independent living and self care, and both immediate and extended social network relationships 
(Goodman, Sewell, Cooley, & Leavitt, 1993);  
17. The Social Disconnectedness Scale and Perceived Isolation Scale, which measure two aspects of social 
isolation: social disconnectedness, or lack of contact with others, and social isolation, or a lack of social 
resources for relationship-building (Cornwell & Waite, 2009a; Cornwell & Waite, 2009b); and 
18. Self Efficacy to Overcome Personal Barriers to Cessation, which is a 9-item scale designed to identify 
those circumstances in which a person feels tempted to smoke.  
 
At this first session, eligible participants will be randomized to one of the two treatment groups. Any Veteran 
who is randomized to the control condition will be informed that a consult will be placed for smoking 
cessation at this facility’s specialty smoking clinic. Participants will be told that he/she will contacted 
approximately nine weeks later, and at, 3, 6, and 12-month follow-up sessions, and that they may be 
contacted briefly prior to these follow-up sessions for a check-in by study staff. 
 
Any Veteran who is randomized to the ART group will be offered up to a 12-week course of NRT in the form of 
nicotine patches and up to two rescue methods (e.g., nicotine lozenge). Participants will be screened for 


Protocol, PI version date 7/21/17  
8 
suitability for NRT or other smoking cessation aids (SCA), including bupropion. Veterans will receive tailored 
amount and delivery type of NRT based on number of cigarettes smoked per day [using an established 
protocol (Bars, et al., 2006)]. All participants who are medically eligible may also be prescribed bupropion. Any 
eligible participants will be prescribed sustained-release bupropion, 150 mg/daily for days 1 to 3 and 300 
mg/daily (administered in two daily doses) for the remaining study period.  Participants will be allowed to 
continue bupropion through the 6 month follow up visit or their final study visit (if they drop out earlier). 
 
NRT will be provided via mail. Should the Veteran want NRT or other smoking cessation aid that is not 
available over the counter, an appointment will be made for him/her in the medication clinic. Dr. Moore will 
write the NRT prescriptions and both Dr. Moore and the study coordinator will work with patient’s primary VA 
physician to discuss contraindications. In those cases in which a participant reports contraindications to NRT 
(e.g., high blood pressure not controlled by medication) or other contraindications to bupropion, the study 
coordinator or Dr. Moore will contact the participant’s primary VA physician in order to obtain authorization 
to use the study medications. In order to determine eligibility to use SCA, study staff will review participants’ 
self-report measures and available CPRS records for any relevant health information. This will include, but is 
not limited to, liver function tests where available, because bupropion use is contraindicated in persons with 
renal impairment, hepatitis, cirrhosis, seizure disorder, and/or uncontrolled diabetes. If a participant with a 
seizure disorder, history of or current hepatitis and/or cirrhosis, renal impairment, and/or uncontrolled 
diabetes wishes to enroll in the study, he/she will not receive contraindicated medications. If a participant 
with any of these medical conditions is unwilling to participate in the study without taking bupropion, he/she 
will be withdrawn from the study. In addition, any participant who has not had a recent liver function test will 
be asked to either participate without taking bupropion or have a blood test (to examine liver function) within 
three months of beginning bupropion. Study medications will be administered and delivered through the 
standard VA pharmacy rather than the research VA pharmacy, as all Veterans are eligible for NRT through the 
VA pharmacy, and the NRT prescribed is not the focus of the study and does not differ from that offered in the 
Stop Smoking Clinic, of which Dr. Moore is the prescribing physician. 
 
Participants will be prescribed nicotine skin patches delivering up to 21 mg/24 hours. Most smokers will be 
prescribed an initial dose of 21 mg patches; smokers reporting light smoking may be asked to use a lower dose 
patch in consultation with the study physician.  Participants will be provided with detailed information and 
education regarding the use of the nicotine skin patches. This educational component will include a rationale 
for using the patches, proper placement of the patch, when to use them, possible side effects, and how to 
report side effects to research staff as they may occur in the course of the study. Dosage of NRT will be 
reduced at two week intervals after it is begun. If a participant indicates any negative side effects of NRT use, 
dose may be adjusted downward based on the physician’s recommendations. All doses will be logged for later 
analysis. Beginning on the identified quit date, participants will be allowed to choose one acute administration 
“rescue method” of NRT from the following: nicotine gum, nicotine lozenge, nicotine inhaler, or nicotine nasal 
spray. This rescue method will be used PRN to reduce cravings during the post-quit period. All medications will 
be mailed to participants. 
 
After randomization, ART participants will receive study equipment, including the smart phone equipped with 
the study app, and CO monitor. Participants will be provided with a manual that summarizes payment 
information and provides instructions on use of the equipment. The CO breath monitor is a hand-held battery 
operated instrument that measures CO in ppm, and provides an LED reading of CO levels. The smart phone 
provided to participants will be the Droid Razr Maxx (Motorola Mobility Inc, Libertyville, IL) or an iPhone 5C. 
The Razr Maxx is a FIPS 140-2 compliant device with a dual-core 1.2 Ghz processor, I GB DDR2 RAM, and 4.3” 
gHD display. The operating system (OS) being utilized for the smart phones is Android 4.1.2, see FIPS 140-2 


Protocol, PI version date 7/21/17  
9 
certificate 1998. The iPhone 5C is a FIPS 140-2 compliant device with 2.4 GHz processor, 4” Retina display. The 
OS being used for the iPhones is iOS 7.1 in FIPS 140-2 encrypted mode; see FIPS 140-2 certificate 2021. In the 
event that the Droid Razr Maxx or iPhone 5C are not available in the future, another FIPS-140-2 compliant 
device may be used upon written approval by the facility’s Information Security Officer (ISO). This policy has 
been developed in conjunction with the ISO. Both phones will be run off the Verizon 4G LTE network because 
Verizon has the best coverage in North Carolina. It is assumed that most participants will only achieve 3G 
speeds and the methods proposed in this project are based on 3G speed availability. For each video recording, 
participants will be asked to 1) begin a recording using the smart phone; 2) show the initial zero CO reading to 
the camera; 3) video record him/herself holding his/her breath during the monitor’s countdown; 4) blow into 
the carbon monoxide monitor while on camera; and 5) show the final CO reading to the camera. Any video 
recordings taken with the phone remain on the phone until the phone undergoes a hard reset (i.e., upon 
return to the lab). It is important for this data to remain on the phone because if technical difficulties prevent 
participants from uploading a viewable video, the study’s technical developer can manually remove the videos 
from the phone to the web-server. This is important because the readings are crucial to the study’s primary 
intervention, and are therefore crucial to gathering reliable and valid data. Study coordinators can monitor 
validity and compliance on a daily basis and offer feedback to ongoing participants regarding compensation. 
Participants will receive training by telephone on how to use the study equipment to perform monitoring; this 
training session will occur at some time point between sessions 1 and 3, depending on the participant’s 
chosen smoking quit date. Participants will not begin actual monitoring until after Session 3. If a participant is 
lost to contact after he/she should have begun home monitoring (defined as two weeks of no contact and no 
video recordings loaded), we will disable the telephone and telephone service, and will only reinstate service if 
the participant contacts the laboratory. In order to enhance ability to reach participants easily, to encourage 
full participation, and to limit losing contact with participants, all participants assigned to ART will be allowed 
to use the study smart phone to make calls to persons other than study staff and to use the phone for text 
messaging to persons other than study staff. An ORD ISO reviewed this procedure, and indicated to the facility 
ISO that we have covered information security well enough to allow participants to use the texting feature on 
the smart phones.  
 
After Session 1 has been completed, the study coordinator, in conjunction with the study physician, will 
perform a medical chart review to determine HIV status. For those participants who are HIV positive, a 
medical record abstraction form will be used to collect baseline information regarding HIV treatment, lab 
results, presence of AIDS-defining illnesses, and medication regimen.  
 
Session 2 (ART participants only). Participants randomized to ART will receive CBT telephone smoking 
cessation counseling. The treatment manual and participant workbook were adapted from the treatment 
manual developed as part of VA Cooperative Studies Program #519 on which Dr. Beckham was a co-
investigator (McFall, et al., 2010), and are consistent with the Public Health Service Clinical Practice Guide 
(Fiore, et al., 2000). During this session, participants will set a smoking quit date to occur the day of Session 4. 
The telephone counseling intervention will be provided by trained clinicians; see “Staff Training” for a 
description of training activities.  
 
 Session 3 (ART participants only). At session 3, participants will receive session two of five of the CBT smoking 
cessation counseling. At this session, any participants who will be using Bupropion will be prompted to begin 
the study medication. They will also be prompted to begin the practice week of mCM. Participants will be 
asked to provide fourteen CO samples prior to Session 4. They will be instructed to take two readings per 24-
hour period, with at least eight hours between each sample. For the first week of monitoring, participants 


Protocol, PI version date 7/21/17  
10 
will be reimbursed $1 per reading for each CO sample that they provide, regardless of the CO reading itself; 
that is, reimbursement is not based on abstinence for the first week of readings. The purpose of this week of 
monitoring is to ensure that there are no difficulties with taking the readings and video, and uploading the 
video to the website. Beginning at Week 2 of mCM, all compensation will be for uploading videos that suggest 
an abstinent CO reading. Participants will 
receive monetary compensation based on 
their own reduced CO readings; see Table 4 
for the abstinence-based payment schedule. 
 
Through the smart phone app, participants 
log-in to a secure website to upload their 
video recordings and see personalized 
information regarding their reinforcement 
information. Participants will not be able to 
view videos once they have been uploaded to 
the secured website; they will see only their 
reinforcement information. Study 
coordinators can monitor validity and 
compliance on a daily basis and offer 
feedback to ongoing participants regarding 
compensation. Because an escalating versus 
a fixed reinforcement schedule has produced 
higher abstinence rates (Heil, et al., 2008, 
Stoops, et al., 2009), an escalating schedule 
will be used in this protocol (identical to our 
pilot study). Participants can check their 
compensation level at any time through the 
application. However, they do not receive 
their final payment until the mCM treatment 
and two-week follow-up period is completed. 
Although in general immediate 
reinforcement is more powerful than distant 
reinforcement, our pilot data indicate that 
the proposed procedure results in patient 
engagement and treatment completion. 
 
Session 4 (ART participants only). During 
Session 4, participants will participate in the 
third of five CBT counseling sessions, which 
corresponds to participants’ smoking quit 
day. During this session, participants will be 
prompted to begin NRT, and to begin 
abstinence mCM (see Session 3 description 
above). 
 
Session 5 (ART participants only). During Session 5, which occurs approximately two weeks after Session 4, 
participants will participate in the fourth CBT counseling session. Participants will continue abstinence mCM. 
Table 4. mCM Reinforcement Schedule 
 
Days 
Post 
Quit 
1st CO 
2nd CO 
Bonus 
Total* 
Week 1 
-1 to -7 
$1.00 
$1.00 
$14.00 
Week 2 
1 
$1.00 
$1.25 
$16.25 
2 
$1.50 
$1.75 
$19.50 
3 
$2.00 
$2.25 
$23.75 
4 
$2.50 
$2.75 
$29.00 
5 
$3.00 
$3.25 
$5.00 
$40.25 
6 
$3.50 
$3.75 
$47.50 
7 
$4.00 
$4.25 
$55.75 
Week 3 
8 
$4.50 
$4.75 
$65.00 
9 
$5.00 
$5.25 
$75.25 
10 
$5.50 
$5.75 
$5.00 
$91.50 
11 
$6.00 
$6.25 
$103.75 
12 
$6.50 
$6.75 
$117.00 
13 
$7.00 
$7.25 
$131.25 
14 
$7.50 
$7.75 
$146.50 
Week 4 
15 
$8.00 
$8.25 
$5.00 
$167.75 
16 
$8.50 
$8.75 
$185.00 
17 
$9.00 
$9.25 
$203.25 
18 
$9.50 
$9.75 
$222.50 
19 
$10.00 
$10.25 
$242.75 
20 
$10.50 
$10.75 
$5.00 
$269.00 
21 
$11.00 
$11.25 
$291.25 
Week 5 
22 
$11.50 
$11.75 
$314.50 
23 
$12.00 
$12.25 
$338.75 
24 
$12.50 
$12.75 
$364.00 
25 
$13.00 
$13.25 
$5.00 
$395.25 
26 
$13.50 
$13.75 
$422.50 
27 
$14.00 
$14.25 
$450.75 
28 
$14.50 
$14.75 
$480.00 
Week 6 
29-35 
$1.00 
$1.00 
$10.00 
$504.00 
Week 7 
36-42 
$1.00 
$1.00 
$10.00 
$528.00 
*Note. Total column indicates possible cumulative payment 
amount. 


Protocol, PI version date 7/21/17  
11 
Any participant using NRT will be prompted to begin using a lower dose patch, and to continue bupropion 
where applicable. 
 
Session 6 (ART participants only). Session 6 will occur two weeks after Session 5. In this telephone contact, 
participants will participate in the final CBT counseling session. Participants will be prompted to continue 
mCM. Beginning at this session, the escalating reinforcement schedule used for the previous four weeks will 
be discontinued, and participants will enter a “wash-out” period in which they are paid $1 for each reading, 
regardless of abstinence. Each week, if participants have provided twice daily readings, they will be paid an 
additional $10 bonus. In session six, any participant using NRT will be prompted to begin using a lower dose 
patch, and to continue bupropion where applicable. 
 
Session 7 (both control group and ART participants only). Session 7 will be a quick telephone check-in. For 
ART group participants, this contact will occur two weeks after Session 6. For control group participants, this 
contact will occur approximately nine weeks after the screening session. In this telephone contact, all 
participants will be asked to rate the helpfulness of any therapy they received. ART group participants will be 
prompted to end NRT use and to continue Bupropion use where applicable. ART group participants will be 
asked return their loaned smart phone and CO monitor, and will be provided a postage-paid mailer for the 
equipment return, and will be offered $50 as incentive for return of the equipment. Any unreturned 
equipment will be reported to the Institutional Review Board (IRB), ISO, facility Privacy Officer (PO), and other 
appropriate personnel as dictated in the Traumatic Stress and Health Research Laboratory’s Standard 
Operating Procedures (SOP) regarding study equipment. This SOP has been previously approved by the 
facility’s ISO, and has been used successfully in by our staff in numerous IRB-approved studies at the Durham 
VA. In addition, we will report any data security and/or privacy issues to the ISO, PO, IRB, and other agencies 
immediately, as dictated by our facility’s Human Research Protection Program SOP.  
 
Results of our recent research have suggested that abstinence rates may improve at 3-month follow-up visits 
when participants are offered a $100 reward for abstinence (rather than simply money for providing a saliva 
sample; see Hertzberg et al., 2013 from IRB #1294 and Carpenter et al., in press from IRB #1666). We would 
like to examine rates of reported abstinence further. Towards that end, prior to Session 8 (3-month follow-up), 
all participants (control and active treatment groups) will be randomized to two conditions for abstinence 
reinforcement and will be informed of their randomization group. Half of all participants will receive $100 for 
biochemically verified (i.e., salivary cotinine) abstinence at Session 8 (abstinence incentive); half will receive no 
incentive pay for abstinence at Session 8 (no abstinence incentive).  
 
Following Session 7, the study coordinator will complete a second medical abstraction form for any participant 
who indicated HIV-positive status at the screening session. 
 
Session 8 (both control group and ART participants). Session 8 will be a 3 month follow-up laboratory visit. In 
this session, participants will be interviewed regarding general functioning (i.e., Role Functioning Scale), social 
isolation, current cigarette use, nicotine dependence, self-efficacy for quitting and/or remaining quit, and their 
use and adherence with SCAs (e.g., nicotine replacement). Medical records will be reviewed to examine and 
corroborate self-reported SCA use. Veterans in both arms will be asked to evaluate the care they received. Any 
participant who reports a relapse to smoking will be interviewed to determine approximate date of relapse 
using the Timeline Follow Back method (Lewis-Esquerre, Colby, Tevyaw et al., 2005). We have recent 
experience using this method to assess daily smoking behavior. Because smoking relapse often occurs in the 
context of substance use, we will evaluate alcohol and cocaine use in conjunction with smoking using this 
procedure. In this session, participants will provide a CO reading and a saliva sample for bio-verification (see 


Protocol, PI version date 7/21/17  
12 
“Biochemical Verification” below). Participants will also be asked to provide a urine sample for a urine drug 
screen. Urine drug screens will only be used as another source of information regarding substance use. If any 
participant is unwilling or unable to attend an in-lab appointment to complete these study procedures, he/she 
will be allowed to complete the measures over the phone and to mail in a saliva sample. Participants who 
cannot come to the lab for the saliva sample will not be asked to provide a urine sample. Participants are sent 
instructions, saliva vials, a brief tobacco use assessment (that includes use of nicotine replacement therapies 
in the prior week), and a postage-paid padded envelope for returning the sample to the study coordinator at 
the VA. The saliva sample will be analyzed for salivary cotinine, a by-product of nicotine. As indicated above, 
any participant randomized to the “abstinence incentive” group will receive $100 for self-reported and CO-
verified abstinence at this session.  
 
Session 9 (both control group and ART participants). Session 9 will be a 6-month follow-up telephone contact. 
In these sessions, participants will be interviewed regarding general functioning (i.e., Role Functioning Scale), 
social isolation, current cigarette use, nicotine dependence, self-efficacy for quitting and/or remaining quit, 
and their use and adherence with SCAs (e.g., nicotine replacement). Medical records will be reviewed to 
examine and corroborate self-reported SCA use. Veterans in both arms will be asked to evaluate the care they 
received. Any participant who reports a relapse to smoking will be interviewed to determine approximate date 
of relapse using the Timeline Follow Back method (Lewis-Esquerre, Colby, Tevyaw et al., 2005). We have 
recent experience using this method to assess daily smoking behavior. Alcohol and cocaine use will also be 
assessed using the method. At Session 9, any participant who was assigned to the ART condition and used 
bupropion as a SCA will be prompted to cease use. Participants will be asked to attend a brief appointment in 
the Traumatic Stress and Health Research Laboratory. During this visit, participants will provide a saliva sample 
and urine sample. As stated above, any participant who is unable or unwilling to attend an appointment will 
be allowed to complete the measures over the phone and to mail in a saliva sample. Only those participants 
who provide a saliva sample in person will be asked to provide a urine sample.  
 
Session 10 (both control group and ART participants). Session 10 will be a 12-month follow-up telephone 
contact. In this session, participants will be interviewed regarding current cigarette use, current e-cigarette 
use, alcohol use, and marijuana use. Participants will be asked to attend a brief appointment in the Traumatic 
Stress and Health Research Laboratory. During this visit, participants will provide a saliva sample and urine 
sample. As stated above, any participant who is unable or unwilling to attend an appointment will be allowed 
to complete the measures over the phone and to mail in a saliva sample. Only those participants who provide 
a saliva sample in person will be asked to provide a urine sample. 
 
In order to enhance participant retention at the 6-month follow-up, we will mail to participants a Veterans’ 
Day card, birthday card, and a “thank you” card. These strategies have been used by Wisniewski and 
colleagues (2006) to increase retention. 
 
Biochemical Verification. Self-reported prolonged abstinence will be verified by cotinine assay after each 
follow-up session. Our choice of primary and secondary smoking endpoints follows recommendations by the 
Society of Research on Nicotine and Tobacco (SRNT; Hughes & Brandon, 2003). Self-reported and bio-verified 
prolonged abstinence at the 6-month follow-up will be the primary end-point. Following definitions used in VA 
CSP-519 (McFall et al., 2010), we define nonabstinence as smoking (or other tobacco use) for 7 consecutive 
days or at least once a week for 2 consecutive weeks. Prolonged abstinence will exclude tobacco use in the 
first two weeks following the quit date (Hughes & Brandon, 2003). Saliva samples will be collected from 
participants who report prolonged abstinence at each follow-up. This process has been shown to improve the 
validity of self-report smoking cessation. After saliva samples are collected, they will be sent for analysis to the 


Protocol, PI version date 7/21/17  
13 
University of California at San Francisco Pharmacology Laboratory for analysis. Coded samples will be sent by 
trained study team members in accordance with the standards of practice outlined in Research Transporting 
and Shipping Biological Specimens, SRS SOP 202, including samples being mailed by trackable courier. Saliva 
samples will be analyzed for the presence of cotinine using a standard cut point off 10 ng/ml to determine 
abstinence. A blind sample of 5% will be run again to assure test accuracy of saliva samples. Secondary 
smoking outcomes will include 7- and 30-day point prevalence abstinence at each assessment, where 
abstinence is defined as no tobacco use in the prior 7 or 30 days respectively (McFall et al., 2010). Any 
participant who provides a saliva sample as requested will be paid $75. We have found in previous IRB 
approved projects (Calhoun IRB #1415) that participants are unlikely to provide saliva for less money than this, 
and given that bioverification of abstinence is crucial to the specific aims of the study, we believe this payment 
is warranted.   
 
Following Sessions 9 and 10, the study coordinator will complete medical abstraction forms for any participant 
who indicated HIV-positive status at the screening session.  
 
During this study, it is anticipated that participants will miss scheduled telephone contacts. This does not 
necessarily constitute a protocol deviation. If a no-show or a missed appointment causes interruption in study 
activities (such as more than 2 days of missed medications), we will report the missed appointments to the IRB 
as protocol deviations. Otherwise, the missed appointments will be recorded in study databases as necessary. 
Also, throughout the study, study staff may contact enrolled participants regarding study-related concerns, 
scheduling/rescheduling appointments, or appointment reminders.  
 
Optional Study Procedures. With subjects’ written consent, contact information containing identifying 
information such as name, address, phone number, and dates of research participation along with diagnostic 
information will be added into a “Contact Database”. The purpose of this database is to re-contact potential 
subjects about future studies for which they may qualify. Potential participants will only be contacted about 
future studies under the direction of Dr. Beckham and her staff. Only Dr. Beckham and her research staff will 
have access to this database, which will be housed on the VA Network’s S:\ Drive (path S:\Nicotine 
Research\Study Information\Study Logbooks).  
 
Diagnostic, demographic, and questionnaire data and other information collected as part of this study will be 
added to a larger database entitled ‘Trauma Database.’ Data coding and complete confidentiality of all subject 
information in the “Trauma Database” will be accomplished in a three-step process. First, information from 
this study will be coded and will only be linked by an assigned random study number. Second, information 
collected from other protocols run by Dr. Beckham will be coded and linked by the random study number. 
Lastly, the information will be merged into the larger “Trauma Database” which will be used for future 
research. Information collected from many study participants (500 or more) from different studies will then be 
examined to inform researchers about the topic they are trying to learn more about. Topics of research 
change over time and for that reason, the development of a combined research database is particularly useful.  
The purpose of combining information collected from numerous studies is to increase the power of the 
statistical analysis of genetic, diagnostic, questionnaire and other assessment data. Each study that deposits 
data into the ‘Trauma Database’ repository will not include any of the 18 individual identifiers under the 
Privacy Rule. 
 
Participant Reimbursement. As described in Table 2 above, participants who are randomized to the control 
group may receive up to $460 for full participation in the study. Participants randomized to the ART condition 
may receive up to $1038 for full participation. Differential rates of payment for the two conditions are 


Protocol, PI version date 7/21/17  
14 
important, as evaluation of the impact of financial contingencies for smoking cessation is central to the study. 
Also, participants randomized to ART will devote much more time and effort into study participation, and 
payment should reflect this additional burden. In each condition, to ensure that patients assigned to the ART 
group return the CO monitor and phone, we are providing postage paid return mailers and adding a $50 
incentive for each equipment return. In order to enhance rates of equipment return, any participant who 
doesn’t return loaned study equipment will have their final payment decreased by $100.  
 
In our previous studies, the follow-up rates for surveys have been consistently less than 75%. We suspect that 
subjects who continue to smoke are less likely to complete the follow-up surveys. Based on our experience in 
our previous HSR&D smoking projects, we are adding a $25 incentive for completing each follow-up survey. 
We have used these incentives in other studies with success (McBride, Bastian, Halabi et al., 2002). If 
participants report abstinence at the 3, 6, and 12 month follow-ups, they will be paid $75 to provide a saliva 
sample.  
 
We will present the overall payment information in the informed consent document; however, rather than 
describe in detail in the informed consent form the payment details for mCM in the ART condition, 
participants assigned to that condition will be provided information about details of payment in the 
instruction manual “mCM: Mobile Contingency Management Manual.” We believe that the payment 
information is detailed and thorough, and that this detailed information would not be useful to provide to all 
participants. Rather, we believe that the information is really only relevant to participants in the ART 
condition.  
 
Payment will be issued to participants via check, as has been consistent with other telephone-based care 
studies run by our study team. Checks for payment will be issued through VA Financial Services. VA has 
recently changed payment options such that Veterans who have a bank account are paid through direct 
deposit into their account. Study staff members are required to complete a “Vendorizing Coversheet” with 
participants, which includes bank account information. Participants will be informed that payment will be 
received approximately 4 to 6 weeks after it is requested.  
 
For those study visits that occur in the research laboratory, participants in both arms may be provided with 
local bus passes in order to facilitate transportation.  
 
Staff Training. Of the study measures utilized, only the SCID requires specific training or skills for 
administration (above a BA degree). As in our other studies, multiple diagnostic raters will be utilized over the 
data collection period. Each rater will be trained using SCID standardized training (i.e., manual, videotapes, 
and co-rating training with a trained rater). Interrater reliability for diagnoses based on videotapes of patient 
interviews across previous studies has been high with a kappa = .96. Additionally, staff providing these 
diagnostic interviews are trained in use of the Psychiatric Emergency Standards of Practice. Training is 
completed and supervised by a Master’s level clinician with experience in psychiatric diagnosis, or by Ph.D. 
level clinical psychologists. Regular clinical supervision is provided on a monthly basis in team interview 
meetings, and consultation is provided regularly to interviewers. 
 
All clinicians who will be providing the smoking cessation counseling intervention will attend a half-day 
training meeting during which they will be trained by Drs. Calhoun & Beckham, both clinical psychologists who 
have extensive clinical and research experience providing cognitive-behavioral interventions for smoking 
cessation. After training, counselors will role-play each counseling session with another staff member. These 
sessions will be videotaped and rated for fidelity and competence by Dr. Calhoun using the Yale Adherence 


Protocol, PI version date 7/21/17  
15 
and Competence Scale system [YACS; (Carroll, 2000)]. Counselors will not be allowed to provide the 
intervention to live participants until they have demonstrated 100% competence and adherence with the 
required elements of each treatment session. During the study, a random selection of twenty percent of all 
counseling sessions will be audio-recorded, using a VA approved audio recorder, and Dr. Calhoun will rate 
counselor treatment fidelity/adherence using the YACS (Carroll, 2000). Only the therapist portion of the 
interaction will be recorded, therefore voice print of the participants will not be collected during these fidelity 
checks. The therapist will ensure that the phone is not being used on speaker, and we will ask therapists not to 
use any names or other identifiers while talking to the participant. At present, VA records control 
requirements do not require us toretain audiorecordings that are collected for the purpose of establishing 
treatment fidelity. Therefore, audiorecordings will be deleted from the approved audio recorder after fidelity 
has been established. The system includes checklists for measuring critical treatment elements. Fidelity 
feedback will be provided to the counselors. In order to protect against drift, the frequency of fidelity review 
will occur equally across the beginning, middle, and end of the intervention period. Counselors will attend 
weekly supervision meetings to review critical points in counseling sessions and receive ongoing consultation. 
 
Rationale for Using and Description of VA Specialty Care as a Control Comparison. We considered using 
primary care based smoking cessation care or telephone counseling as the control comparison. Although 
national clinical practice guidelines (CPG) suggest that intensive interventions associated with specialty care 
are “more effective than less intensive interventions and should be used whenever possible,” (Fiore, et al., 
2000) there is significant disagreement in the tobacco control field regarding how smoking cessation care 
should be structured (Sherman, et al., 2006). Many experts emphasize treatment in specialty clinics has been 
shown to be most efficacious (Fiore, et al., 2000) as well as most cost effective (Cromwell, et al., 1997). Others, 
citing low enrollment rates in specialty care, argue that primary care approaches should be emphasized (Stead 
& Lancaster, 2002). Sherman and colleagues (Sherman, et al., 2006) assessed the institutional approach to 
implementing tobacco CPG among 40 VA facilities. Results suggest that most sites emphasized a specialty 
approach and some restricted medications to those attending a specialty clinic. Thus, our decision to compare 
the ART intervention to specialty care was based both on recommendations from the CPG and evidence 
suggesting that it is currently the preferred approach among VA facilities (Sherman, et al., 2006).  
 
The DVAMC has a long history of providing state-of-the-science specialty smoking cessation care. The specialty 
Smoking Cessation clinic currently employs the QuitSmart Program (Shipley et al., 1999), which was developed 
locally and is now used extensively throughout the VA system. The clinic provides group treatment and 
telephone counseling provided by doctoral-level psychologists and medication management provided by 
psychiatry. Patients receive three group counseling sessions provided over 6 weeks, a telephone counseling 
session following their quit date, NRT (up to three forms), bupropion and potentially varenicline (if multiple 
quit attempts with NRT and bupropion have failed). The treatment is manualized, which will allow us to easily 
measure which aspects of the intervention were administered to the patient by a review of medical records. 
 
Cost-Effectiveness Measures  
Smoking cessation counseling alone or in combination with NRT has been shown to be highly cost effective 
(Song, et al., 2002). We will estimate the cost and cost-effectiveness of the ART and VA specialty care. 
Approaches to accounting for costs and outcomes in cost analyses can vary widely. One important variable is 
the perspective taken in the analysis, i.e., the standpoint from which costs and benefits are realized. 
Consistent with previous work in this area and with expert panel recommendations (Gold, et al., 1996), we 
have chosen to take a broad societal perspective as opposed to the unique perspective of the patient, VHA, or 
other third-party payer. We considered the measurement of future resource utilization costs as an outcome 
variable, e.g., differences between groups in the costs associated with the number of outpatient and inpatient 


Protocol, PI version date 7/21/17  
16 
visits in the year following the intervention. It is unlikely, however, that groups will differ in smoking-related 
illness visits in the year following the intervention. Thus, consistent with the Public Health Service (PHS) task 
force guidelines (Gold, et al., 1996) we propose to use quality adjusted life year (QALY) as the primary 
outcome. Additionally, we made decisions regarding cost measurement outcomes. Proposed costs will include 
both intervention delivery costs and participant costs. Costs associated with the development of the 
interventions will be excluded from the analyses as these costs have already been incurred and are thus 
“sunk” costs. 
 
Costs to be collected can be grouped into two broad categories: intervention delivery costs and participant 
time costs. Intervention costs incurred to develop both interventions will be excluded from the analysis as 
these costs have already been incurred and are thus “sunk” costs. 
 
Costs for both conditions will be estimated using standardized estimates of support staff and our 
interventionists. The time it takes to prepare for and execute the intervention used in specialty care is already 
prescribed in the QuitSmart treatment manual. We will use surveys and counselor record to validate these 
estimates. Providers will be asked to provide time estimates for sessions associated with a subset of 30 
patients randomly chosen to estimate time use (see below). Similar methods will be used to estimate time 
spent in preparing advanced clinic access letters and scheduling appointments (Specialty Care). The time it 
takes to prepare for and execute the cognitive-behavioral telephone counseling for the ART intervention is 
specified in the treatment manual but will be assessed through a data tracking system (time spent on all 
intervention calls will be recorded using interventionist input). Similar methods will be used to estimate time 
spent in contacting and training Veterans on the use of the mCM smart phone app. Our study physician will 
use a similar data tracking system to measure time spent administering NRT and other SCAs to participants. 
The value of time spent on the intervention will be assessed using VA salary and benefits data, and by applying 
relevant salary and benefit costs to the quantity of time spent by different study staff. In addition to labor 
costs, materials costs, including the cost of nicotine lozenge, inhaler, mCM and the smart phone, and costs of 
compensation to participants will be collected. Dr. Van Houtven’s group has experience collecting time logs of 
activities and has published cost effectiveness studies (Wang, et al., 2012). Her group has built proprietary 
database collection applications tailored to the various interventions being studied at the Durham HSR&D 
Center of Excellence.  
 
Evaluation of participant time costs will include the time spent by smokers in using the intervention strategies, 
techniques, or information. As part of the 3-month follow-up, time spent on the intervention materials other 
than those involved in the telephone sessions (and attendance to the smoking cessation specialty clinic) will 
be assessed. In the intervention arm, the number of videos submitted will be used to assess the time involved 
in providing bio-verification as part of mCM. We will derive participant time cost estimates for individuals in 
each group by combining the time estimates with standard wage estimates adjusted for age, gender, and if 
possible, race as derived from the Statistical Abstract of the US. Because we chose to conduct the cost-
effectiveness analysis from the societal perspective, the use of mean wage rates has higher generalizability 
and validity than self-reported wages by the participants.  
 
We propose to estimate participant time by a random sample of participants at key points in the intervention. 
This is intended to minimize participant burden while collecting reliable measures of participant time use for 
both ART treatment and comparison participants. Specifically, at randomization, 30 patients (15 in ART and 15 
in Specialty Care) will be selected randomly to be a part of the time use study. At three different time periods 
in the intervention (1 week, 3 weeks and 6 weeks), participants will be asked to answer time use questions for 
the full range of the intervention tasks in which they engage (e.g. total time spent recording and uploading 


Protocol, PI version date 7/21/17  
17 
readings for ART participants; time spent receiving feedback for ART participants, or time spent on CBT for 
usual care participants). ART participants will be prompted to answer these questions using their loaned smart 
phone. Control group participants will be contacted by phone during those weeks to answer time use 
questions. Randomly selecting 30 patients and varying the dates of data collection will allow the time study to 
reflect the learning curve of delivering and participating in the intervention by smart phone (and in CBT), yet it 
will not be announced to patients when the time study will occur so that people do not adjust behavior. The 
approach for providers will mirror that used for patient time use.  
 
The primary effectiveness outcome measure will be quality-adjusted life years (QALYs) (Fiscella & Franks, 
1996). The QALY is a standardized effectiveness measure that allows for the comparison of the value of a 
particular intervention to a broad range of other potential health care investments. Differences in trial quit 
rates among Veterans in the ART and control group will allow us to identify changes in the QALY effectiveness 
measure across groups. To estimate the QALYs, we will employ the methods and estimates developed by 
Fiscella and Franks (Fiscella & Franks, 1996), who derived estimates of the increase in QALYs due to smoking 
cessation from published life expectancy data (Rogers & Powell-Griner, 1991), adjusting for the impact of 
smoking cessation on health-related quality of life. For analyses, quit rates at the 6-month follow-up will be 
utilized. Participants who remain abstinent from smoking at the 6-month follow-up will be considered 
sustained quitters and assigned an age and gender specific increase in QALY. 
 
RISK/BENEFIT ANALYSIS 
 
The clinical interview to establish diagnosis can cause some psychological distress in the form of a temporary 
increase in anxiety, but any ensuing distress is usually well tolerated. There are no known psychological 
hazards or risks associated with completing questionnaires. Risks also include discomfort related to quitting 
smoking. Quitting smoking will cause nicotine withdrawal that may lead to headaches, nausea, irritability, 
weight gain, difficulty concentrating, poor sleep, increased appetite, anxious or depressed mood, and craving 
for cigarettes. Participants in the ART condition will be offered NRT, and it is likely that participants in the 
control condition will also be offered NRT. There are risks associated with the use of NRT. Minimal risks 
associated with wearing a nicotine patch include skin irritation, dizziness, lightheadedness, increased heart 
rate or blood pressure, nausea or vomiting. Risks of bupropion use include dry mouth, insomnia, nausea, 
constipation, headache, shakiness or jitteriness, skin rash, sweating, allergic reaction, change in appetite, 
weight loss, dizziness, tremor, thinking abnormally, hot flashes, worsening depression or suicidal thoughts and 
behavior, and ringing in the ears. At the highest dosage of bupropion to be used in this study, seizures 
occurred in 1 out of every 1000 (0.1%) who took this drug. Participants are informed that they are not 
required to take bupropion, and will be allowed to participate in the study if they refuse to do so. In both 
conditions, there is a potential risk associated with the loss of confidentiality of study data.   
 
ART participants have a greater risk of violation of confidentiality and/or privacy in the study. Specifically, 
collection and transfer of videotaped carbon-monoxide monitoring have risks with regards to privacy and 
confidentiality. We have limited the likelihood that participant identification will occur by developing a 
method for training participants to provide only their side profile, as a side profile may not be considered a 
full-face image, and may limit identifiability. In addition, we allow participants to review any videos prior to 
uploading them, and participants may choose to delete any video that they feel violates their privacy. In 
previous studies using this methodology that have been run in the Traumatic Stress and Health Research 
Laboratory, we have had no participant complaints regarding issues of privacy and confidentiality related to 
use of the smart phone videotaping procedures. Care has been taken to ensure that data collection and 
transport is in keeping with the most recent VHA Handbook 6500, which addresses information security. Data 


Protocol, PI version date 7/21/17  
18 
is encrypted at rest on the smart phone with encryption that is FIPS 140-2 compliant, and is encrypted upon 
transport and at rest, as well. These methods are the required methods for collection and transfer of PHI and 
PII. 
 
The Traumatic Stress and Health Research Laboratory has established, IRB-approved standards of practice for 
the evaluation of risk of suicide and homicide. The policy includes a thorough risk assessment including 
evaluation of risk factors and protective factors associated with both suicide and homicide. Also included in 
the policy are differential recommendations for action based on determinations of low, moderate, or high risk. 
Any staff member conducting an interview in which moderate or high risk is determined will contact a senior 
staff person with clinical expertise in risk assessment (including the PI, co-investigator(s), and/or the DVAMC’s 
Psychiatric Emergency Clinic or Emergency Room). 
 
Serious adverse events will be promptly reported to the VA IRB as required.  All project staff will complete 
educational units required by the Durham VAMC Human Subjects Committee.  
 
Participants may benefit from this study by stopping smoking. 
 
Protection of Vulnerable Population. The VA has identified persons who are homeless as an “other vulnerable 
population.” It is presumed that one of the primary vulnerabilities of this population is the risk of undue 
influence from monetary compensation. In designing this research intervention, careful consideration has 
been given to the risk of undue influence. Divergent with our typical design, which includes compensation for 
attendance at most or all study sessions, we have designed the study such that compensation is mostly based 
on obtaining and maintaining abstinence from smoking, especially within the ART condition. Within the 
control group, more than 55% of the total possible payment is related to smoking abstinence. In the ART 
condition, more than 70% is related to smoking abstinence. We believe that the risk of undue influence is 
greatly diminished with this design, and that the potential health benefits of smoking cessation greatly 
outweigh the risk of influence through compensation for cessation. 
 
DATA SAFETY AND MONITORING 
 
Quitting smoking should enhance rather than jeopardize health status, and potential serious adverse events 
(SAE) for participants in this project are not expected. Regardless, we will minimize potential risk by careful 
screening of potential participants. In the ART condition, those with contraindications for NRT will require 
medical clearance by their primary care provider or the study physician or they will not receive NRT. Similar 
clearance is often required of Veterans enrolled in DVAMC’s specialty smoking cessation clinic.  
 
The individuals responsible for data safety and monitoring will be the PI, the project manager, and the Study 
Physician. The Study Physician for this trial will be Scott Moore, M.D., Ph.D. Dr. Moore is a board certified 
general psychiatrist, and is the treating physician of the DVAMC’s specialty smoking cessation clinic. As the 
Study Physician, Dr. Moore will ensure participants are medically cleared to participate in this trial and will 
review all reports of adverse events (AEs) sent by the study coordinator and evaluate the patient as necessary 
to determine whether there is any corrective action needed. Dr. Michael Hertzberg will serve as a backup 
prescriber.  
 
Further data safety and monitoring will be provided by the PI. There will be several ongoing mechanisms for 
monitoring and reporting of adverse events: 1) ongoing participant contact via study personnel, 2) a toll-free 
number provided to participants to report concerns related to study participation; and 3) weekly meetings 


Protocol, PI version date 7/21/17  
19 
between the PIs and study personnel. 
 
Prior to initiation of any smoking cessation aid, participants will be informed again of the potential risks and 
side-effects associated with NRT. Participants also will be able to call directly via the study toll-free number to 
report AEs. This toll-free number, directed to the project manager’s phone, will be provided to all participants 
upon entry into the study.  
 
The PI will meet at least weekly with study personnel to discuss participants’ reactions to the intervention, 
proper delivery of the intervention, and any adverse events or unanticipated problems. Monthly meetings 
between the investigators and the project manager will allow for ongoing progress reports, including the 
number of participants currently involved in the study groups, attrition rates, and scheduled data collection 
from participants, as well as notification and review of any AEs. Safety monitoring for adverse events (AEs) will 
be conducted in real time by the PI and/or project manager. The following information about adverse events 
will be collected: 1) the onset and resolution of the AE, 2) an assessment of the severity or intensity (use 
existing grading scales whenever possible), 3) an assessment of the relationship of the event to the study 
(definitely, probably, possibly or not related), and 4) action taken (e.g., none, referral to physician, start or 
increase concomitant medication). The PI will determine the severity of the event, will assign attribution to 
the event, and will monitor the event until its resolution. Any adverse events will be reported to the IRB in 
accordance with the local Human Research Protection Program’s Standards of Practice.  
 
DATA MANAGEMENT AND SECURITY 
 
Several types of data will be collected over the course of the study. As described under the Request for Waiver 
or Alteration of Informed Consent and HIPAA Authorization for Research, PHI to be collected during 
recruitment activities includes name, address, telephone number, and social security number. Other data to 
be collected over the course of the study (as described in the HIPAA authorization) include name; address; 
phone number; social security number; dates of study visits; account numbers (for Veterans who have bank 
accounts, payment will be issued via direct deposit, which requires a Vendorizing Coversheet that asks for 
account information and VA Form 10-7078 to be obtained), and images potentially comparable to a full-face 
image. Sources of health information include medical history and physical exam information, videorecordings, 
saliva and urine specimens, progress notes in CPRS, laboratory test results, survey responses, alcohol and/or 
drug use information, and mental health notes. This information will be used for research purposes only.  
 
Any hard copy data collected over the course of the study will be stored in a locked file cabinet in a locked 
office suite in the Traumatic Stress and Health Research Laboratory at the Durham VA Medical Center. Hard 
copy data will include, but is not limited to, any information gathered from potential participants during the 
telephone screening process, participant consent forms and HIPAA authorization forms, laboratory test 
results, and VA forms 10-3203 and 10-9012. 
 
The study team will develop and maintain two databases for the study. The first will be a computer assisted 
telephone interviewing system that will facilitate the collection of patient measures at baseline, end of 
treatment, and 3 and 6-month follow-up. The primary database engine technology underlying this system will 
be the MySQL database server hosted by the VA Information Resource Center (VIReC). MySQL is a relational 
database management system. The coded data collected during telephone interviews will be managed using 
REDCap electronic data capture tools hosted at the Department of Veterans Affairs' VIReC. We have chosen 
REDCap because it facilitates the easy development, collection and entry of research data, it is available at no 


Protocol, PI version date 7/21/17  
20 
cost, and it is hosted within and only accessible from the VA's intranet. All data collected can be exported into 
a number of standard formats including SAS, MS Access, and SQL. 
 
Second, the study team will develop a MS Access tracking database that will electronically track participants 
through all components of the study. This tracking data will contain identifiable data, including the key that 
links participants to study identification numbers; other data collected in the course of the study will be kept 
separately from identifying information. This database will be stored on a VA secured computer server 
(S:\Nicotine Research\Study Information\Study Logbooks) that is encrypted, password-protected, and only 
accessible by Dr. Beckham and study staff. The key to seed recruitment coupons that connects the 
participant’s study ID number with the seed ID number will be kept in a database separate from other PHI, 
creating two layers of separation between the seed ID and the already-participating Veterans’ identifying 
information. 
 
We have used similar methods of data entry in our prior studies, and internal audits show excellent reliability. 
All data transactions within and between systems will run through controlled, secure transactions to ensure 
the preservation of database integrity and privacy. Of primary importance in all study activities will be the 
security and protection of Veterans’ private health information (PHI). All staff will complete educational 
modules designed to improve good clinical practices, improve protection of participant privacy, and promote 
information security and research compliance. Participants’ identifying information will only be available to Dr. 
Beckham and the research staff at the VA Medical Center. If any staff member leaves the research staff, 
he/she will be removed from the staff listing, and access to the study’s data will be immediately withdrawn. 
The key and other study data will be kept in accordance with VA records control requirements, and if 
destruction is required by records control requirements, research data will be destroyed in accordance with 
VA records control requirements. As mentioned above, audio recordings made for treatment fidelity review 
will be deleted after review.  
 
Within the ART arm of the study, we have developed several ways to minimize data security risk with video-
taping. Participants will be specially trained to provide only partial-face images during the videos, and we ask 
participants not to speak while making a video so that a voice print is not collected. The smart phone is 
programmed such that a staff member will set up the telephone and enter the participant’s code into the 
phone. When the participant chooses to upload a video, they upload the video directly from the phone to a 
secured website (see below for further information about the website), and the phone programming ensures 
that the video is uploaded into the correct participant’s area of the website. This ensures that study 
participants’ data is stored in the correct place, and that study participants cannot view any other participants’ 
data. Participants are asked to review their videos before posting, and they can choose not to upload any 
video that they don’t wish to upload for any reason. Please see “Study Procedures” for more information 
about the technology used in the study. 
 
For the study’s website, we will use shared server space provided by InMotion Hosting, Inc. The study url is 
https://www.calhounlab.com. Server space is currently used through a Duke University contract, and is shared 
with other VA and Duke IRB-approved studies run in the Traumatic Stress and Health Research Laboratory (PIs 
Dr. Beckham and Calhoun). We will be using AES-256 encryption. The video recordings will be collected on 
devices that are FIPS-140-2 compliant. The data at rest at InMotion Hosting is AES-256 encrypted at rest, and 
the data being transferred is encrypted at transfer (AES-256). Website properties indicate TLS 1.0, AES w/ 128 
bit encryption (High); RSA with 2048 bit exchange. Data will be unencrypted only by study staff who have 
access to the secured server at InMotion Hosting; the encryption key is held only by our staff. This will ensure 
all video uploads and data that the participant sends over the internet via their phones will only be transferred 


Protocol, PI version date 7/21/17  
21 
over encrypted network connections, essentially nullifying the possibility of someone gaining access to the 
video before it reaches our server. Data stored on this website are coded in that no direct identifiers are 
placed on the website. Videos are stored via study ID number, and participants are trained to provide side 
facial images without voice imprint. InMotion also runs audits regularly of the websites hosted within their 
shared servers to prevent scriptside vulnerabilities, as well as having a 24/7 support team monitoring their 
servers. The web application written for this study has been checked for SQL injection, Code Injection, XSS, 
and RFI vulnerabilities and has passed. The site will only be accessible by the study participants and the study 
coordinators via 512-bit SHA-2 hashed passwords. 
 
In order for data analysis to occur using MplusV7 software and SAS software (see “Data Analyses” below), a 
coded dataset will be sent to VINCI for analysis using VA-owned data analysis software (SAS). In the event that 
MplusV7 software or appropriate SAS modules for analysis are not available through VINCI, coded data will be 
moved to Duke University Medical Center for analysis. Any data movement outside the protected VA 
environment will be accomplished using a VA-issued and owned FIPS-140-2 encrypted thumb drive loaned to a 
VA study staff member. Data will be stored at Duke on a protected server to which only Dr. Beckham and her 
study staff have access; data are encrypted at rest.  
 
DATA ANALYSES 
 
The study is a randomized two-arm parallel group, longitudinal trial. The primary analysis will be based on 
intention to treat principles; the overall intervention effect will be measured for the entire sample assuming 
participants have followed their randomized assignment. The main conclusions drawn from this trial will be 
based on the pre-specified hypotheses outlined below and will be tested with two-sided p-values at the 
standard 0.05 level. Statistical analyses will be performed using SAS (Version 9: SAS Institute Cary NC) and 
MplusV7.   
 
Missing Data and Attrition Rates. Because the main predictors of interest, treatment group and 
demographics, are collected at baseline, we do not anticipate much missing data. We do, however, anticipate 
missing values in the longitudinal outcomes owing to dropout or an inability to reach the patient by phone. 
The primary analysis will be based on intention to treat principles and will use a missing=smoking approach 
(treating those who dropped out of the program as current smokers). Although conservative, this approach 
produces an estimate of the verifiable efficacy of the intervention based on a representative sample rather 
than a potentially inflated estimate based on an unspecified sub-sample (An, et al., 2009, West, et al., 2005) 
and is recommended by the SRNT (Hughes, et al., 2003, Hughes, et al., 2004).  
 
Hypothesis 1: Abstinence rates will be significantly higher among Veterans randomized to the ART 
intervention as compared to those randomized to VA specialty smoking cessation clinic. Rates of abstinence 
from cigarettes (self-reported prolonged abstinence) will be assessed at post-treatment, 3-months, 6-months, 
and 12 months follow-up. At each time point, abstinence will be measured as a dichotomous variable 
(abstinent or not). Self-report of abstinence will be validated with saliva testing of cotinine levels. The primary 
endpoint is abstinence rate at 6 months. Following the suggestion of a reviewer, we will use logistic regression 
to test for a between-group difference in the proportion of Veterans with bio-verified abstinence from 
cigarettes at the primary, 6-month follow-up. This logistic regression model can be written: Logit(pi) = β0 + 
ARTi*β1 , where pi represent the probability that patient i has abstained from smoking at 6-months of follow-
up. In this model, ARTi indicates whether or not patient i is in the ART intervention group of the study; 
therefore, β1 represents the log-odds ratio of smoking abstinence in the ART group as compared to the 


Protocol, PI version date 7/21/17  
22 
Control group. We will first formally test the intervention effect by testing that β1 differs from zero. We will 
also explore whether there is a group effect over time using a repeated measures logistic regression model, in 
which the model parameters are estimated using generalized estimating equations methodology (GEE). GEE 
methodology allows the relationship between the response and explanatory variables to be modeled 
separately from the correlations resulting from clustering of repeated measurements within each subject. The 
regression coefficients from a GEE model have essentially the same interpretation as those from a cross-
sectional regression analysis (e.g. logistic regression) but are more appropriate as they properly incorporate 
the longitudinal structure of the data. The predictors in the model will include intervention arm (a 2-level 
variable) and a time effect (post-treatment, 3-months and 6-months). Time will be considered as categorical 
and we will explore whether an exchangeable, unstructured, or AR(1) correlation structure is most 
appropriate to take into account the within-patient correlation between the repeated measures over time. 
GEE modeling will be performed using the SAS PROC GENMOD.  
 
As participants are aware that their self-report will be evaluated by biochemical verification, the majority of 
reports are concordant with test results (> 90% in our current trials). For any discrepancies between self-
report and biochemical verification, we plan to determine the sensitivity of model estimates when using 
results of cotinine assays as the dependent variable. 
 
Hypothesis 2: ART treatment will result in greater cost-effectiveness as measured by the incremental cost-
effectiveness ratio. The cost data from the VHA Databases and participant surveys will be utilized to calculate 
cost-effectiveness. The economic analysis will follow the guidelines developed by the Panel on Cost-
Effectiveness in Health and Medicine (Gold, et al., 1996). We will employ the societal perspective (i.e., all costs 
incurred by and benefits accruing to the society in general, the VA health care system, and the individual 
participants, including medical, non-medical, productivity), with secondary analyses from the VA health care 
system perspective. The VA health care system perspective, which is most relevant to VA decision makers, 
excludes the direct non-medical costs borne by Veterans, such as the costs of their time. Data on the effects 
and costs of the interventions will be used to estimate the incremental cost-effectiveness, or ICER (US$ per 
QALY) comparing the ART intervention to VA specialty smoking cessation intervention. The incremental cost-
effectiveness ratio R is expressed as: R = (µCT - µCU) / (µET - µEU), where µ denotes the estimated mean for CT 
(cost of ART intervention), CU (cost of specialty smoking cessation intervention), ET (effect of ART), and EU 
(effect of specialty smoking cessation intervention). Time duration of the economic analysis will be 6 months. 
To incorporate the uncertainty in the data into the cost-effectiveness analysis, we will develop a decision 
analytic model and conduct probabilistic sensitivity analysis (2nd order Monte Carlo simulation). Parameter 
estimate ranges with appropriate distributions will be used for the various intervention and participant times, 
wage rates, NRT costs, and QALY effectiveness measures in conducting the decision model simulation. We will 
present our results as means (with CIs), incremental cost-effectiveness analysis scatterplots, cost-effectiveness 
acceptability curves, and one-way sensitivity analysis of model variables that drive the results (Briggs, et al., 
2006, Willan & Briggs, 2006). 
 
Hypothesis 3: The ART treatment effect will be partially mediated by increased self-efficacy compared to the 
control condition. The self-rating of efficacy collected across study time period will be utilized to evaluate this 
meditational hypothesis. If there is a significant intervention effect upon smoking cessation at 6-months 
follow-up, then we also plan to examine whether change in self-efficacy mediates the impact of the 
intervention. Change will be defined as the difference between baseline and post-treatment. To assess 
mediation, significance of the indirect effect of the intervention on smoking cessation via change in self-
efficacy will be determined using bootstrapping methods. Bootstrapping employs resampling with 
replacement to generate confidence intervals that adhere to the positive skew inherent to indirect effects. 


Protocol, PI version date 7/21/17  
23 
Relative to conventional tests of mediation, such as Sobel’s z, which do not account for this skew and 
therefore inflate the standard error of the indirect effect, bootstrapping methods are quite powerful. 
Mediation analyses will use standard linear and logistic regression modeling approaches and will be conducted 
with Mplus v7. Considering that self-efficacy will be measured at four time points—baseline, post-treatment, 
3-month follow-up, and 6-month follow-up—we will also examine whether differences by condition in 
abstinence rates across the study are mediated by changes in self-efficacy from time point to time point. Using 
linear and logistic GEE models and following mediation procedures for nested data (Krull & MacKinnon, 1999), 
we will first examine differences in abstinence by condition at time t (post-treatment, 3-month follow-up, and 
6-month follow-up), controlling for abstinence at time t-1 (baseline, post-treatment, and 3-month follow-up). 
This is equivalent to modeling group differences in change in abstinence rates over the course of the study 
(Raudenbush & Bryk, 2002). We will then test differences by condition in self-efficacy at time t-1 and then test 
whether the differences by condition in abstinence at time t observed in the first model are attenuated with 
the addition of self-efficacy at time t-1. 
 
Supplementary Aim 1 and Exploratory Analyses. To explore the effect of psychiatric symptoms (i.e., PTSD, 
depression, and alcohol abuse symptoms) on abstinence rates, analyses will be conducted by adding the 
subgroup variable (psychiatric symptoms vs. none) and its interaction with the intervention indicator to the 
statistical models described above under hypothesis 1. The interaction term will be tested to determine if the 
treatment effect is consistent across the levels of the subgroup variable at 3 and 6-month follow-ups.  
 
Supplementary Aim 2: To determine the impact of smoking status on HIV disease progression parameters, 
presence of AIDS-related illnesses, CD4 T-cell count, and viral load at each time point will be modeled via 
multilevel modeling as a function of concurrent smoking status.  
 
Sample Size Considerations. Power calculations provided below were performed with Power Analysis and 
Sample Size software (PASS, Version 12: NCSS LLC, Kaysville, Utah). The sample size estimate is based on the 
first hypothesis; i.e., the ART intervention will result in higher  quit rates from cigarettes at 6 months post-
randomization and was calculated for a logit-linked logistic regression model with a two-sided type-I error rate 
of 5%. Six months was chosen as the primary endpoint as it is generally recognized as the standard follow-up 
duration for reporting data from clinical trials and is consistent with the SRNT recommendations (Hughes, et 
al., 2003). As described in the analysis section, we are adopting a missing=smoking approach as recommended 
by the SRNT (Hughes, et al., 2003, 2004) and all randomized patients will be included in the analyses. That is, 
any participant who is randomized and drops out will be counted as a smoker. Our estimates below reflect this 
method. 
 
Because homeless smokers are typically excluded from smoking cessation trials, there are few data that 
directly address potential efficacy of existing smoking cessation interventions in this population. For example, 
while there is evidence that provider contact and advice is associated with a measurable effect on smoking 
cessation in non-homeless smokers (Fiore, et al., 2000), physician contact had no impact on smoking rates in a 
study of 754 homeless persons including homeless Veterans (Tsai & Rosenheck, 2012). Using administrative 
data we calculated the observed Impact of usual VA specialty care for homeless smokers. In a random sample 
of homeless smokers (N=100) with an address in Durham county we found that 46% were referred to Specialty 
Smoking Cessation Care. Of these, 11 homeless Veterans attended at least one session of the intervention 
resulting in reach defined as 24% (11 of 46). Estimates of attendance rates for VA specialty care in non-
homeless Veterans range from 6% to 30% (Sherman, et al., 2005, Yano, et al., 2008) and in our quality 
improvement evaluation of DVAMC specialty care we found that only 16% of non-homeless Veterans referred 
to specialty care attend at least one session. Among those accessing care, only 3 completed the program (73% 


Protocol, PI version date 7/21/17  
24 
attrition rate) and only one Veteran quit smoking. Thus, the observed efficacy was 9% (1 of 11 Veterans who 
received any treatment quit smoking). The resulting impact of specialty care would equal 2% where Impact = 
Reach (.24) X Efficacy (.09). Note, drop-outs are included in this calculation of efficacy as treatment failures. 
Even if the efficacy of VA specialty smoking cessation care was as high as the average efficacy rate observed 
for interventions that combine multiple treatment formats including self-help materials, group counseling, and 
telephone counseling, i.e., 23% (95% CI, 19.9%-26.6%) among non-homeless smokers (Fiore, et al., 2000), 
specialty care impact would only approach 5%.  Thus, we expect the overall quit rates (impact) of specialty 
care to fall between 2% and 5%. 
 
Cessation rates for ART are based on our pilot data. Five homeless Veterans were randomized to active mCM 
in our first pilot examining mCM in Veteran smokers with PTSD and to date 20 have enrolled in our open trial 
of ART. In the first study of PTSD smokers, the observed efficacy rate was 40% (2 Veterans quit and remained 
abstinent at 3 months; 1 dropped out of treatment (20% treatment attrition) and did not quit; 2 did not 
respond to the 3-month follow-up are presumed to be smoking). In the open trial, 3-month efficacy rates 
among the 20 Veterans are 65%. Collapsing across these trials (n=25), observed 3-month cessation rates are 
60%. This rate is consistent with observed short term (end of treatment) quit rates in similar CM interventions 
with non-homeless populations [e.g., (Alessi, et al., 2004, Roll, et al., 1996)]. We have included a 6-month 
follow-up in our open trial of homeless smokers and the current bio-verified efficacy rate (missing=smoking) at 
6-months is 57% (8 of 14 who are eligible for a 6-month follow-up remain abstinent). We conservatively 
powered the trial with the expectation that there will be a larger relapse rate between 3 to 6 months than the 
one we have observed (see Gilpen, et al., 1997, Zhou, et al., 2009); thus we expect the 6-month quit rate for 
ART will fall between 22%-32%. Based on a 2-sided test, alpha=.05, we would need to enroll between 24 
subjects (e.g., 2% vs 32%) or up to 63 subjects (e.g., 5% vs. 22%) in each arm to achieve 80% power to detect 
expected differences and will randomize a total of 126 subjects to ensure sufficient power at the primary 
endpoint.  
 
STUDY DISSEMINATION AND ADVISORY BOARD 
 
This study will utilize a Consumer, Family and Expert Provider Advisory Board that will meet annually with the 
research team to provide guidance to the project, develop goals for consumer involvement, and provide 
advice on dissemination issues. The board will consist of members representing consumers (e.g., homeless 
smokers, providers), family members, and content experts in homelessness, and will be led by Dr. Eric 
Elbogen, Clinical Psychologist for the DVAMC Psychosocial Rehabilitation and Recovery Center (PRRC) 
Program. At present, the board will include 1) a previously homeless Veteran who has quit smoking; 2) Dennis 
Culhane, Ph.D., the Director of Research for the National Center on Homelessness Among Veterans; 3) Jeff 
Doyle, LCSW, VISN 6 Homeless Coordinator; and 4) Lindsey Arledge, LCSW, Supervisor of the Homeless 
Veterans Program at Durham VA Medical Center.  
Table 6 shows a list of planned dissemination activities. Our group has established roles in key partnerships 
with opinion leaders in the VA responsible for disseminating novel smoking cessation programs that will 
significantly aid in the dissemination of this work. We include support letters from (1) Dr. Kim Hamlett-Berry, 
Director of both the VA Public Health National Prevention Program and the VA Smoking and Tobacco Use 
Table 6. Dissemination Plan 
End Users 
Organizations/Network 
Activities & 
Modalities 
Dissemination Partner 
VA 
Veterans 
Study participants 
(1) Letter to 
participants 
 


Protocol, PI version date 7/21/17  
25 
Scientific 
Community 
VA MIRECC;  VA HSR&D; Society for 
Research on Nicotine and Tobacco; 
International Society for Traumatic 
Stress Studies  
(1) Newsletters,      
(2) Websites       
(3) Presentations    
(4) Publications 
Dr. John Fairbank, 
Director, VISN-6 
MIRECC 
Dr. Patrick Calhoun, 
Research Associate, 
HSR&D 
Opinion 
Leaders 
VA Public Health National Prevention 
Program 
(1) Consultation      
(2) Presentation 
Dr. Kim Hamlett-Berry, 
Director  
SUD QUERI: Tobacco Use Cessation 
Workgroup 
Dr. Scott Sherman, 
Chair 
VA National Center for Health 
Promotion & Disease Prevention 
Dr. Linda Kinsinger, 
Director 
National Center on Homelessness 
among Veterans 
Vincent Kane, M.S.W., 
Director  
Director of both the VA Public Health National Prevention Program and the VA Smoking and Tobacco Use 
Cessation Technical Advisory group, (2) Dr. Scott Sherman, Chair of the Smoking and Tobacco Use Cessation 
Work Group of the Substance Use Disorders QUERI, (3) Dr. Linda Kinsinger, Director of the VA National Center 
for Health Promotion, and (4) Vincent Kane, M.S.W., the Director of the National Center on Homelessness 
among Veterans. 
 
 


Protocol, PI version date 7/21/17  
26 
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