Clinical trial NCT01932996
Conditions: Cigarette Smoking Tobacco Smoking Smoking, Tobacco
Keywords: Smoking Cessation Smoking Cessation Products Tobacco Use Cessation Products
Sponsor: University of Minnesota
Start date: 2015-01-01; Completion date: 2018-10-31
Enrollment: 352 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this research study is to enhance smoking cessation rates for homeless smokers. The original study design proposed to test the effects of 1) an Intensive Smoking Intervention, and 2) integrating alcohol abuse treatment with smoking cessation We will utilize a 3-group randomized design to test study hypotheses. The three study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A); 2) Intensive Smoking Intervention using CBT-(IS); or 3) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). Due to low enrollment because of the addition of an alcohol use screening criteria, the study was changed to a two arm study and the study time frame changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A) and 2) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). The study length is reduced to 26 weeks from 52 weeks. All participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge. Counseling will follows the protocol used in a recent study of alcohol dependent smokers and will include weekly individual sessions for 3 months followed by study data collection visits 3 months. Both study conditions will have equal number of study contacts. Study staff will make retention contacts with participants in the community during weeks that do not have study visits scheduled. Primary smoking outcome is cotinine-verified 7-day smoking abstinence at week 26 follow-up while secondary outcome is prolonged smoking abstinence at weeks 12, 16, and 26. Secondary alcohol outcome will be self-reported continuous alcohol abstinence for 90 days at week 26. Recruitment and retention will be enhanced by use of gift cards, bus passes, other non-monetary incentives, attractive intervention materials, collaboration with homeless shelters, and advice from a Community Advisory Board. Participants will be enrolled from homeless shelters and facilities in the 7-county greater Minneapolis/St. Paul metro area. Our power calculation indicates that a sample size of 215 per study condition is needed to detect proposed treatment effects.

Detailed description:
To achieve the study goal, we have selected a 3-group randomized clinical trial (RCT) design that includes 1) Usual Care, 2) Intensive smoking cessation, and 3) Integrated Intensive Smoking and Alcohol Intervention. Due to low enrollment because of the addition of an alcohol use screening criteria, the study was changed to a two arm study and the study time frame changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A) and 2) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). The study length is reduced to 26 weeks from 52 weeks. Having alcohol treatment added to the smoking intervention will enable us assess whether addressing alcohol abuse will result in improved smoking abstinence, an important scientific question that has never been studied in homeless populations.

Study conditions: Both study conditions have identical number of contacts; we considered a design in which the duration of counseling in the UC will be identical to those in the IS+A condition but decided against this because it will create a usual care condition that exceeds standard practice for brief interventions. We understand that testing hypothesis 3 confounds contact time with treatment content, and hence we will not be able to determine that observed differences in outcome are due to specific treatment components. However, given the current state of knowledge about treating homeless alcohol abusing smokers, we believe it is sufficient to show that our intervention led to improved outcome in this group without knowing if the finding is due to specific intervention content. Subsequent research will be needed to disentangle various intervention components.

All participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge. Counseling will include weekly individual sessions for 3 months followed by study data collection visits for 3 months. Each participant will be randomly assigned to a condition, which will dictate their treatment. Each participant will be asked to engage in the therapy assigned to their condition, and work to quit smoking and consuming alcohol over a period of one year.

Arms: arm 1: IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months. arm 2: UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines
Interventions: intervention 1: nicotine patch plus nicotine gum/lozenge intervention 2: Intensive Alcohol Intervention
Intervention descriptions: intervention 1: 12-week treatment with nicotine patch plus nicotine gum/lozenge intervention 2: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months

Protocol documents:
Prot_SAP_000.pdf: 
PROTOCOL TITLE: Enhancing Smoking Cessation in the Homeless Population 
VERSION DATE: 11/15/2017 
 
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PROTOCOL TITLE: 
Enhancing Smoking Cessation in the Homeless Population 
ClinicalTrials.gov:  
NCT01932996 
PRINCIPAL INVESTIGATOR or FACULTY ADVISOR: 
Name: Rebekah Pratt 
Department:  Family Medicine and Community Health 
Telephone Number:  612-625-1196 
Email Address:  rjpratt@umn.edu 
STUDENT INVESTIGATOR:  N/A 
Name  
Current Academic Level (e.g., Medical Student, Resident) 
Department 
Telephone Number 
Email Address (must not be a personal email address) 
VERSION NUMBER/DATE: 
Version 1, November 15, 2017 
 
 


PROTOCOL TITLE: Enhancing Smoking Cessation in the Homeless Population 
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REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


PROTOCOL TITLE: Enhancing Smoking Cessation in the Homeless Population 
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Table of Contents 
After completing your protocol, right click on the Table of Contents below and select 
“Update Field.” If prompted, select “Update entire table.” This will automatically 
update the protocol sections and page numbers for you. Do this also each time you 
modify your protocol after initial approval. 
 
1.0 
Objectives ................................................................................................................ 7 
2.0 
Background .............................................................................................................. 7 
3.0 
Study Endpoints/Events/Outcomes .......................................................................... 9 
4.0 
Study Intervention(s)/Investigational Agent(s)...................................................... 10 
5.0 
Procedures Involved............................................................................................... 10 
6.0 
Data and Specimen Banking .................................................................................. 13 
7.0 
Sharing of Results with Participants ...................................................................... 13 
8.0 
Study Duration ....................................................................................................... 14 
9.0 
Study Population .................................................................................................... 14 
10.0 Vulnerable Populations .......................................................................................... 15 
11.0 Local Number of Participants ................................................................................ 16 
12.0 Local Recruitment Methods ................................................................................... 16 
13.0 Withdrawal of Participants .................................................................................... 18 
14.0 Risks to Participants ............................................................................................... 18 
15.0 Potential Benefits to Participants ........................................................................... 19 
16.0 Data Management .................................................................................................. 20 
17.0 Confidentiality ....................................................................................................... 22 
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants .................... 22 
19.0 Provisions to Protect the Privacy Interests of Participants .................................... 23 
20.0 Compensation for Research-Related Injury ........................................................... 23 
21.0 Consent Process ..................................................................................................... 23 
22.0 Setting .................................................................................................................... 24 
23.0 Multi-Site Research ............................................................................................... 24 
24.0 Resources Available............................................................................................... 25 
25.0 References .............................................................................................................. 25 
 


PROTOCOL TITLE: Enhancing Smoking Cessation in the Homeless Population 
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ABBREVIATIONS/DEFINITIONS 
Include any abbreviations or definitions for key or technical terms you use in your 
protocol. 
 
[Abbreviation/Definition 1] 
 
[Abbreviation/Definition 2] 
 
[Abbreviation/Definition 3] 
 
All abbreviations used in this document are first spelled out when used for the first time 
with the abbreviated acronym in parenthesis.  
 
 
 


PROTOCOL TITLE: Enhancing Smoking Cessation in the Homeless Population 
VERSION DATE: 11/15/2017 
 
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STUDY SUMMARY 
 
Study Title 
Enhancing Smoking Cessation in the Homeless 
Population 
Study Design 
The goal of this study is to enhance smoking 
cessation rates for homeless smokers by testing 
effects of 1) an Intensive Smoking Intervention, and 
2) integrating alcohol abuse treatment with smoking 
cessation. We initially utilized a 3-group 
randomized design to test study hypotheses. The 
three study conditions were: 1) Integrated Intensive 
Smoking plus Alcohol intervention using cognitive 
behavioral therapy, CBT—(IS+A); 2) Intensive 
Smoking Intervention using CBT—(IS); or 3) Usual 
Care (brief smoking cessation and brief alcohol 
counseling both based on the USPHS’s 
Guidelines)—(UC). The addition of the alcohol use 
criteria resulted in nearly two-thirds of those 
screened to be deemed ineligible. Consequently the 
study was revised to eliminate the Intensive 
Smoking Intervention using CBT—(IS) arm and the 
study period reduced from 52 weeks to 26 weeks to 
improve enrollment into the intensive smoking and 
alcohol and usual care arms. All participants receive 
12-week of treatment with the nicotine patch plus 
nicotine gum/lozenge. Counseling follows the 
protocol used in a recent study of alcohol dependent 
smokers and includes weekly individual sessions for 
3 months. Both study conditions will have equal 
number of study contacts. Study staff make 
retention contacts with participants in the 
community during weeks that do not have study 
visits scheduled. Primary smoking outcome is 
cotinine-verified 7-day smoking abstinence at week 
26 follow-up while secondary outcome is prolonged 
smoking abstinence at weeks 12 and 26. Secondary 
alcohol outcome will be self-reported continuous 
alcohol abstinence for 90 days at week 26. 
Recruitment and retention will be enhanced by use 
of gift cards, bus passes, and other non-monetary 
incentives. Participants will be enrolled from 
homeless shelters and facilities in the 7-county 
greater Minneapolis/St. Paul metro area. 
Primary Objective 
Hypothesis 1: At 26 weeks post randomization, 
homeless smokers who receive Integrated Smoking 


PROTOCOL TITLE: Enhancing Smoking Cessation in the Homeless Population 
VERSION DATE: 11/15/2017 
 
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plus Alcohol Intervention (IS+A) will have 
significantly better biochemically-verified 7-day 
abstinence rate from cigarette smoking compared to 
those who received Usual Care (UC). 
Hypothesis 2: At 26 weeks post randomization, 
homeless smokers who receive Integrated Smoking 
plus Alcohol intervention (IS+A) will have 
significantly better 90-day abstinence rate from 
alcohol consumption compared to smokers who 
receive Usual Care (UC). 
Exploratory Aim 
Hypothesis 3: At 26 weeks post randomization, 
homeless smokers who receive Intensive Smoking 
Intervention (IS) will have significantly higher 
biochemically-verified 7-day abstinence rate from 
cigarette smoking compared to those who receive 
Usual Care (UC). 
Secondary Objective(s) 
1. To evaluate how smoking cessation or reduction 
relate to psychosocial factors such as levels of 
depression, hopelessness, and perceived stress at 
weeks 12 and 26 follow-up 
2. To evaluate how alcohol abstinence or reduction 
relate to psychosocial factors such as levels of 
depression, hopelessness, and perceived stress at 12 
and 26 weeks follow-up. 
3. To evaluate how treatment outcomes relate to 
history of other substance abuse 
4. To evaluate, how treatment outcomes relate to 
opportunities for employment and housing, as well 
as overall health and well-being. 
5. To evaluate participants' perceptions of the 
acceptability and usefulness of components of the 
various interventions 
Research 
Intervention(s)/Investigational 
Agents 
NA 
IND/IDE # (if applicable) 
NA 
Investigational Drug Services 
# (if applicable) 
NA 
Study Population 
Homeless adult men and women who smoke 
cigarettes and drink alcohol 
Sample Size (number of 
participants) 
428 
Study Duration for Individual 
Participants 
26 weeks 
 
 


PROTOCOL TITLE: Enhancing Smoking Cessation in the Homeless Population 
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1.0 
Objectives 
1.1 Purpose:  
Although the overall prevalence of smoking in the United Sates has 
declined, rates remain strikingly high (70%) in homeless 
populations. A majority of homeless smokers also abuse alcohol and 
other drugs which makes quitting more difficult and heightens the 
health consequences of tobacco use. However, most smoking 
cessation research has excluded this most vulnerable segment of our 
population. Over the past several years, our research team conducted 
studies aimed at reducing tobacco use in homeless populations. The 
first National Institute of Health (NIH)-funded (R01HL081522; 
Okuyemi, Pl) smoking cessation clinical trial (n=430) targeted 
homeless smokers with 8-week treatment with nicotine patch and 6 
sessions of motivational interviewing (Ml). This relatively low 
intensity study showed cotinine-verified 7-day quit rates of 9.3% for 
Ml vs. 5.6% for Brief Advice at 26 weeks. We also found that 
quitting smoking was associated with reduced alcohol use. These 
smoking quit rates are low compared to the general population, 
demonstrating the challenge for tobacco interventions in this 
population and the need for more research. The goal of this study is 
to evaluate interventions designed to enhance smoking cessation 
rates for homeless smokers by testing the effects of 1) intensive 
smoking intervention (i.e. higher dose and duration than our previous 
R01), and 2) integrating alcohol abuse treatment with smoking 
cessation. We utilize a 2-group randomized design to test study 
hypotheses. The study conditions are: 1) Integrated Intensive 
Smoking intervention using cognitive behavioral therapy (CBT) plus 
Alcohol intervention -(IS+A) and, 2) Usual Care (brief smoking 
cessation and brief alcohol counseling both based on the US Public 
Health Service's Guidelines). In addition, all participants receive 12-
weeks of treatment with a combination of nicotine patch plus gum or 
lozenge. 
2.0 
Background 
2.1 Significance of Research Question/Purpose:  
Despite strikingly high rates of tobacco use in homeless populations, there is 
limited empirical data about how to help homeless smokers quit smoking. 
Because quit rates are low in homeless populations it is critical to develop 
more powerful interventions for improving cessation rates. Given that the 
majority of homeless smokers also abuse alcohol, a logical next step to 
improve smoking cessation rates in this group is to address their alcohol 
abuse along with a more intensive pharmacological and behavioral smoking 
cessation intervention. 
2.2 Preliminary Data:  


PROTOCOL TITLE: Enhancing Smoking Cessation in the Homeless Population 
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2.3 This study is a follow-up study to the initial study, Power to Quit (PTQ) that 
used a similar study design. An association was noted between smoking 
cessation/reduction and alcohol cessation/reduction. We conducted a 
secondary analysis to examine the association between smoking cessation 
and substance abuse in the PTQ study. Participants with verified abstinence 
at week 26 had greater reduction in alcohol drinking days compared to 
participants who did not quit smoking (-3.8 vs. -0.8; p=0.05). We also 
examined the quit rates at 26 weeks by alcohol use status at 8 weeks among 
the subset that reported drinking alcohol on one or more days at baseline 
enrollment. Alcohol drinkers at baseline who reported quitting alcohol at 8 
weeks follow-up had higher smoking abstinence rate (10.1%) at week 26 
follow-up compared with those remained drinkers.  
2.4 Existing Literature:  
1) Goldade K, Whembolua GL, Thomas J, et al. Designing a 
smoking cessation intervention for the unique needs of homeless 
persons: a community-based randomized clinical trial. Clinical 
Trials. 2011 Dec;8(6):744-54. This paper describes the design of the 
study, recruitment procedures, eligibility criteria, and detailed 
overview of the intervention components. These proven and 
effective recruitment and retention methods will be used in the 
proposed study;  
2) Okuyemi KS, Goldade K, Whembolua GL, Thomas JL, Eischen 
S, Guo H, Connett JE, Grant J, Ahluwalia JS, Resnicow K, Owen G, 
Gelberg L, Jarlais DD. Smoking characteristics and comorbidities in 
the power to quit randomized clinical trial for homeless smokers. 
Nicotine Tob Res.2013 Jan; 
15(1):22-8..  This paper describes the smoking characteristics and 
co-morbid conditions of study participants including the prevalence 
of alcohol use and abuse among homeless smokers;  
3) Okuyemi KS, Goldade K, Whembolua GL, et al. Effects of 
Motivational Interviewing and Nicotine Patch for Smoking 
Cessation among Homeless Smokers. (In press): Addiction. Using 
intent-to-treat procedures counting those lost to follow-up as 
smokers, quit rates at week 26 were 9.3% and 5.6% for intervention 
and control respectively (p=0.15). Those adherent to MI (attended 5 
of 6 sessions) had higher quit rates than nonadherents at week 8 
(10.9% vs. 3.0%; p=0.02) and week 26 (8.5% vs. 4.0%; p=0.19). We 
used a GEE logistic regression (Figure 1), model to analyze the 
longitudinal outcomes for the CO-verified abstinence at weeks 1, 2, 
4, 6, 8 and 26 including time and intervention group as predictors. 
The odds ratio for the MI vs. Control was 1.40 (95% CI=0.93-2.11; 
p= 0.11);  
4) Borja C, Goldade K, Olayinka A, et al.  Participation of Homeless 
Persons in a Smoking Cessation Randomized Controlled Trial. (Submitted) 


PROTOCOL TITLE: Enhancing Smoking Cessation in the Homeless Population 
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Addictive Behaviors.  This paper described the recruitment and eligibility of 
homeless smokers who participated in the PTQ study. Working with local 
shelters, a total of 847 adult smokers were screened for study eligibility of 
which 580 (68.5%) met eligibility criteria.  Of those eligible, 430 (74.1%) 
returned for randomization. Eligible participants who returned for 
randomization were older and more likely to have a phone number 
compared to eligible participants who were not enrolled in the study.  
Knowledge of these factors including inclusion and exclusion criteria may 
help researchers tailor criteria that accurately identify and include homeless 
smokers in future clinical trials. 
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome:  
Primary Aims 
To assess the efficacy of a) intensive smoking intervention and b) 
integrating alcohol abuse treatment with smoking cessation among homeless 
smokers. 
 
Primary Hypotheses 
Hypothesis 1: At 26 weeks post randomization, homeless smokers who 
receive Integrated Smoking plus Alcohol Intervention (IS+A) will have 
significantly better biochemically-verified 7-day abstinence rate from 
cigarette smoking compared to those who received Usual Care (UC). 
 
Hypothesis 2: At 26 weeks post randomization, homeless smokers who 
receive Integrated Smoking plus Alcohol intervention (IS+A) will have 
significantly better 90-day abstinence rate from alcohol consumption 
compared to smokers who receive Usual Care (UC). 
 
Exploratory Aim 
Hypothesis 3: At 26 weeks post randomization, homeless smokers who 
receive Intensive Smoking Intervention (IS) will have significantly higher 
biochemically-verified 7-day abstinence rate from cigarette smoking 
compared to those who receive Usual Care (UC). 
 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s):  
1. To evaluate how smoking cessation or reduction relate to psychosocial 
factors such as levels of depression, hopelessness, and perceived stress at 
weeks 12 and 26 follow-up. 
2. To evaluate how alcohol abstinence or reduction relate to psychosocial 
factors such as levels of depression, hopelessness, and perceived stress at 12 
and 26 weeks follow-up. 
3. To evaluate how treatment outcomes relate to history of other substance 
abuse. 


PROTOCOL TITLE: Enhancing Smoking Cessation in the Homeless Population 
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4. To evaluate, how treatment outcomes relate to opportunities for 
employment and housing, as well as overall health and well-being. 
5. To evaluate participants' perceptions of the acceptability and usefulness 
of components of the various interventions. 
4.0 
Study Intervention(s)/Investigational Agent(s) 
4.1 Description:  
The study is a 2-group randomized design to test study hypotheses. The two 
study conditions are 1) Integrated Intensive Smoking plus Alcohol 
intervention using cognitive behavioral therapy, CBT—(IS+A); 2) Usual 
Care (brief smoking cessation and brief alcohol counseling both based on 
the USPHS’s Guidelines)—(UC). All participants receive 12-weeks of 
treatment with a nicotine patch plus nicotine gum/lozenge. Counseling 
follows the protocol used in a recent study of alcohol dependent smokers 
and includes weekly individual sessions for 3 months. All study participants 
complete weekly study surveys during the first 12 weeks and at weeks 14, 
16, 18, 22 and 26. Both study conditions have equal number of study 
contacts. Study staff make retention contacts with participants in the 
community during weeks that do not have study visits scheduled. Primary 
smoking outcome is cotinine-verified 7-day smoking abstinence at week 26 
follow-up while secondary outcome is prolonged smoking abstinence at 
weeks 12 and 26. Secondary alcohol outcome is self-reported continuous 
alcohol abstinence for 90 days at week 26. Recruitment and retention are 
enhanced by use of gift cards, bus passes, weekly raffles, and other non-
monetary incentives. Participants are enrolled from homeless shelters and 
facilities in the 7-county greater Minneapolis/St. Paul metro area.  
 
4.2 Drug/Device Handling:  
N/A    
4.3 IND/IDE:   
N/A     
4.4 
Biosafety:   
N/A      
 
4.5 
Stem Cells:   
N/A 
 
5.0 
Procedures Involved 
5.1 Study Design:  
The study is testing effects of an intensive smoking intervention integrating 
an alcohol abuse intervention with smoking cessation using a 2-group 
randomized design. The two study conditions are 1) Integrated Intensive 


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Smoking plus Alcohol intervention using cognitive behavioral therapy, 
CBT—(IS+A) or 2) Usual Care (brief smoking cessation and brief alcohol 
counseling both based on the United States Public Health Service’s 
Guidelines)—(UC). All participants receive 12 weeks of treatment with 
nicotine patches plus nicotine gum or lozenges. Participants randomized to 
the counseling arm receive cognitive behavioral therapy for tailored for 
smoking cessation and for alcohol cessation. Both study conditions have 
equal number of study contacts. Participants are scheduled for weekly visits 
during the first 12 weeks of the study and also at weeks 14, 16, 18, 22, and 
26. Study staff make retention contacts with participants in the community 
during weeks that do not have study visits scheduled. Primary smoking 
outcome is cotinine-verified 7-day smoking abstinence at week 26 follow-
up while secondary outcome is prolonged smoking abstinence at weeks 12 
and 26. Secondary alcohol outcome is self-reported continuous alcohol 
abstinence for 90 days at week 26. Recruitment and retention are enhanced 
by use of gift cards, weekly raffles, bus passes, and other non-monetary 
incentives. Participants are enrolled from homeless shelters and facilities in 
the 7-county greater Minneapolis/St. Paul metro area. 
 
5.2 Study Procedures:  
Participants are recruited at Twin City area homeless shelters and service 
organizations serving homeless adults to complete an eligibility survey to 
determine if they meet the eligibility requirements of the study. Eligible 
participants are scheduled for the baseline enrollment visit at which time 
study staff explain the study in detail, obtain consent, administer a baseline 
date collection survey and randomize the participant to one of the two study 
arms. Participants are scheduled for weekly data collection surveys and 
counseling sessions for those randomized to the counseling arm for the first 
12 weeks of the study and every other week (14, 16 and 18) and at weeks 22 
and  26.  
In the usual care, or control, arm, participants receive 12 weeks of NRT 
(nicotine replacement treatment) and one-time brief (~15 minutes) 
counseling for smoking cessation and alcohol cessation. The smoking 
cessation counseling is based on the 5 A’s model (Ask, Advise, Assess, 
Assist, Arrange) recommended by the US Public Health Service Clinical 
Practice Guidelines. Consistent with the guidelines, counselors conduct the 
following procedures: a) congratulate the participant on enrolling in the 
study, b) describe the harms related to smoking and the benefits of quitting, 
c) advise the participant to quit immediately, d) assist participants to set a 
quit date, e) encourage participants to tell friends and families about their 
quitting, and f) describe potential relapse situations and other barriers to 
quitting. The brief alcohol counseling follows Public Health Service 
guidelines and include elements such as a) presenting screening results, b) 
identifying risks, c) discussing consequences, d) soliciting commitment, e) 


PROTOCOL TITLE: Enhancing Smoking Cessation in the Homeless Population 
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identifying goals, and f) giving advice and encouragement. At the end of the 
session, participants interested in additional smoking or alcohol intervention 
are referred to local and national treatment programs. 
Participants in intensive integrated smoking and alcohol counseling 
condition receive 12 weeks of NRT treatment plus weekly individual 
cessation counseling sessions. Counseling utilize CBT (cognitive behavioral 
therapy) techniques. The counselor assists participant to set and prepare for 
their quit date targeted for the day after randomization. Initial CBT sessions 
focus on identifying situations, activities, moods, and thoughts associated 
with cigarette smoking, strategies for coping with trigger events and 
smoking urges, etc.  Counseling is also be tailored to address challenges 
peculiar to homeless persons including boredom, lack of structure in daily 
life, and dealing with the stress related to meeting competing social needs 
(e.g. food, housing, safety, grooming, etc.). The remaining sessions focus on 
relapse prevention. This protocol was used in a recent study by our research 
team.  
The alcohol counseling is distinct from smoking counseling and does not 
emphasize similarities between quitting smoking and stopping alcohol and 
drug use. This is based on findings from a study that reported that 
emphasizing these similarities led to worse drinking outcomes compared to 
concurrent treatment that did not emphasize the similarities. Alcohol 
treatment is based on a CBT manual developed for Project MATCH, an 8 
year NIH multi-site alcohol treatment study and was used by our research 
team in a recent study.  About 40 minutes of each session is devoted to 
alcohol treatment to include identifying alcohol antecedents, coping with 
alcohol urges, managing thoughts about alcohol, problem solving, drink 
refusal skills, planning for emergencies, assertiveness training, and 
enhancing social support networks for alcohol abstinence. 
At weekly study sessions staff ask about any issues the participant may be 
experiencing with the products. An adverse event form is completed if 
participants report any side effects from use of the nicotine replacement 
products. Participants receive additional two-week supplies as needed. 
At each study visit, the study survey asks if the participant was hospitalized 
or visited the emergency room since their last visits. An adverse event form 
is completed if either event occurred. Study staff also assess to determine if 
the participant is currently exhibiting incoherence, disorganized speech, or 
marked loosening of associations and if so, administer the Short Blessed 
Test to assess cognitive concerns in the areas of orientation, memory, and 
concentration. Additionally, at each study visit participants are assessed for 
suicidal ideation. The Columbia Suicide Severity Rating Scale is 
administered anytime a participant answers affirmatively to the question: 
“over the last 2 weeks, how often have you been bothered by thoughts that 
you would be better off dead or of hurting yourself in some way?” If the 
result of the Columbia indicates they have intention or a plan, they are 


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escorted by study staff to the medical clinic at the shelter, to COPE 
(Community Outreach for Psychiatric Emergencies), or to the nearest 
hospital emergency room. 
Participants are compensated with a Visa or American Express gift card of 
varying amounts at each study visits and also receive a $5 Subway gift card 
or a non-monetary incentive such as a backpack, word finder game, pocket 
calendar, playing cards, or water bottle. During the first 12 weeks and at 
weeks 16 and 26, participants are offered a raffle draw for an additional 
incentive to increase retention at these key data collection points. 
Visa/American Express card denominations vary from $10 for most visits to 
$75 at week 26 for the final study visit and data collection survey. 
5.3 Follow-Up: 
Data collection includes biologic (height, weight, salivary cotinine, alcohol 
breathalyzer, expired carbon monoxide and urine pregnancy tests for women 
of child-bearing age), demographic, homeless history, smoking history, 
NRT adherence and data from the following instruments: 
Alcohol Use Disorders Identification Test (AUDIT), Cessation Progress, 
Treatment Self-Regulation for Smoking, Fagerstrom Test for Nicotine 
Dependence, Morisky Adherence, modified MN Nicotine Withdrawal Scale, 
Brief Questionnaire of Smoking Urges, Pittsburgh Sleep Quality Index, 
Clinical Withdrawal Assessment of Alcohol Scale Revised (CIWA), 
Columbia Suicide Severity Rating Scale, Penn Alcohol Craving Scale, Rost-
Burnham substance use screener, PHQ-9, Mini-International 
Neuropsychiatric Interview (MINI) Anxiety, MINI Psychotic Symptoms, 
Short-Blessed Test, Perceived Stress Scale, Self-Efficacy for Smoking 
Control, Self-Efficacy for Alcohol Control, Partner Interaction 
Questionnaire, Motivation and Confidence contemplation ladder, social 
network size questionnaire, social engagement questionnaire, Interpersonal 
Support Evaluation List, Cessation Support from Partner or Buddy, and 
participant feedback interviews. 
  
5.4 Individually Identifiable Health Information: 
HIPCO file and HIPAA authorization form uploaded. 
 
5.5 Use of radiation: 
N/A 
5.6 Use of Center for Magnetic Resonance Research:  
N/A 
6.0 
Data and Specimen Banking 
N/A 
7.0 
Sharing of Results with Participants 


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No data of this nature is collected or shared with participants. 
8.0 
Study Duration 
8.1 Describe: 
 
The study duration for participants is 26 weeks. 
 
Enrollment is scheduled to end on March 31, 2018. 
 
Study procedures are expected to end by September 20, 2018 and data 
analysis before study end on March 31, 2019. 
9.0 
Study Population 
9.1 Inclusion Criteria:  
The study population is homeless adults who smoke cigarettes and drink 
alcohol. Homeless individuals are considered to be undervalued, often 
disenfranchised and are vulnerable due to their disadvantage in the 
distribution of social goods and services including income, housing, and 
healthcare. This study specifically targets homeless to learn how to address 
the healthcare disparities they face with lack of access to smoking cessation 
interventions and lack of research identifying successful smoking cessation 
strategies that work for homeless individuals wishing to quit smoking. 
 
Individuals must meet the following criteria to be considered for study 
inclusion: 
• Currently homeless (as defined in the Stewart B. McKinney Act passed by 
the US congress in 1987) 
• Smokes > 5 cigarettes per day in past 7 days 
• Smoked at least 100 cigarettes in lifetime 
• AUDIT score ≥5 
• Aged 18 years or older  
• Willing to attend study sessions and follow other study protocol 
9.2 Exclusion Criteria: 
Individuals will be excluded for the following reasons: 
• Use of smoking cessation medications or interventions in last 30 days 
• Unstable medical illness that requires immediate medical care 
• AUDIT score <5 or >27  
• Pregnancy or other NRT contraindications 
• Current history or in past 6 months of psychotic disorder or major 
depressive disorders that is not stable on treatment for past 3 months (as 
determined by the study psychiatrist) 
• Cognitive impairment (as measured by the Short Blessed Test) 
9.3 Screening: 
To make screening and participation convenient for participants, all study visits 
occur at local homeless shelters. Interested individuals complete an eligibility 
survey administered by study staff to determine if they are eligible to enroll. The 


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10-item AUDIT scale is used to screen for alcohol use disorders with scores less 
than 5 indicating abstinent or low-risk alcohol users and a score over 27 indicative 
of hazardous use or alcohol dependence. The Short Blessed Test will be 
administered to determine cognitive capacity to participate. The 7-item Psychotic 
Disorders and Mood Disorder with Psychotic Features scale of the Mini 
International Neuropsychiatric Interview (MINI) is administered to screen for 
psychotic disorders. Those who screen positive for psychotic disorders or major 
depression may be enrolled provided they have been stable in treatment for past 
three months. This determination is be made by the study Psychiatrist, Dr. Sheila 
Specker, who oversees screening and necessary referrals for these psychiatric 
disorders. To be enrolled in the study, participants must be able to meet study staff 
at designated homeless shelters. Individuals may screen for eligibility up to five 
times with a minimum one month window between screenings. This allows those 
deemed ineligible due to unstable medical conditions the ability to potentially 
enroll once their health is stable. Eligible individuals are scheduled for a follow-up 
visit to enroll and be randomized to a study condition.   
10.0 Vulnerable Populations 
10.1 Vulnerable Populations: Identify which of the following populations will be 
involved in this study. (You may not include members of the populations 
below as participants in your research unless you indicate this in your 
inclusion criteria above.) 
☐ Children 
☐ Pregnant women/Fetuses/Neonates 
☒ Prisoners 
☒ Adults lacking capacity to consent and/or adults with diminished 
capacity to consent, including, but not limited to, those with acute 
medical conditions, psychiatric disorders, neurologic disorders, 
developmental disorders, and behavioral disorders 
☐ Approached for participation in research during a stressful situation such 
as emergency room setting, childbirth (labor), etc. 
☒ Disadvantaged in the distribution of social goods and services such as 
income, housing, or healthcare 
☐ Serious health condition for which there are no satisfactory standard 
treatments 
☐ Fear of negative consequences for not participating in the research (e.g. 
institutionalization, deportation, disclosure of stigmatizing behavior) 
☐ Any other circumstance/dynamic that could increase vulnerability to 
coercion or exploitation that might influence consent to research or 
decision to continue in research 
☒ Undervalued or disenfranchised social group 
☐ Members of the military 
☐ Non-English speakers 
☐ Those unable to read (illiterate) 
☐ Employees of the researcher 


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☐ Students of the researcher 
☐ None of the above 
10.2 Adults lacking capacity to consent and/or adults with diminished capacity to 
consent: 
Justification for inclusion of population:  
The study specifically targets homeless adult men and women some of 
whom are mentally ill, chemically dependent, members of a minority racial 
and/or ethnic group, and clearly from economically and often educationally 
disadvantaged populations. The specific aims of the study are to identify 
effective methods to assist homeless individuals interested in quitting 
smoking and drinking alcohol with the understanding that methods that are 
effective in the general public may not be effective with individuals facing 
the challenges of homelessness as well the life challenges contributing to 
their homelessness - mental illness, substance abuse, structural racism, and 
lack of economic resources and education. 
The study has numerous validated assessments that are administered as part 
of the eligibility screening process and the weekly data collection survey 
process that assess for ability and competency to enroll in the study and to 
maintain participation once enrolled. Assessments include assessing for 
cognitive ability (Short Blessed Test), alcohol withdrawal (Clinical Institute 
Withdrawal Assessment of Alcohol Use, Revised), physical health 
(documentation of hospital and emergency room visits), mental health 
(PHQ-9, MINI Anxiety, MINI Psychotic Symptoms), suicidal ideation 
(Columbia Suicide Severity Rating Scale), current alcohol use and 
breathalyzer testing to ensure potential and current participants are capable 
and able to enroll and participate in the study tasks. 
We minimize the risks by administering numerous assessments at eligibility 
screening and at each study session to ensure that at each study visit the 
participant is coherent, medically and psychologically stable, and not 
impaired by alcohol or alcohol withdrawal.   
 
10.3 Additional Safeguards: 
The study does not enroll pregnant women, does not involve neonates, 
prisoners or individuals under the age of 18. 
11.0 Local Number of Participants 
11.1 Local Number of Participants to be Consented:  
We plan to enroll a minimum of 428 to allow data analysis with a maximum 
enrollment of 645 participants. 
 
12.0 Local Recruitment Methods 


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12.1 Recruitment Process: 
Study participants are recruited from homeless shelters and facilities in the 
Minneapolis/St Paul area that serve homeless adults. Homeless shelters 
include Dorothy Day Center, Salvation Army Harbor Light, United Gospel 
Mission, Naomi Family Center, Emma Norton Center, Our Savior’s Shelter, 
St. Stephen’s Shelter, and Simpson House. Organizations serving homeless 
adults include the Catholic Charities Opportunity Centers, Listening House, 
the Veteran’s Service Center, Hennepin and Ramsey County detoxification 
centers, Sharing and Caring Hands, Higher Ground and the Hennepin 
County Healthcare for the Homeless programs. Recruiting from multiple 
homeless shelters and service providers make the study more accessible for 
participants and ensures a more representative sample.  
Study staff post recruitment flyers with tear-off tabs that contain the study 
phone number and email and hand out half-page flyers to individuals who 
express interest in the study the above-listed sites. 
12.2 Source of Participants: 
Participants are recruited from homeless shelters and organizations 
providing services to homeless adults through face-to-face contact and from 
recruitment flyers with the study phone number and email address to contact 
the study. 
12.3 Identification of Potential Participants: 
Potential participants self-identify in response to posters and to the study 
staff during outreach at selected sites. Interested individuals complete an 
eligibility survey that is administered by study staff to determine if they 
meet the inclusion requirements of the study. 
12.4 Recruitment Materials:  
The study uses two types of print materials to recruit. One is a full page (8 
½” x 11”) poster with tear-off tabs at the bottom. These are posted on the 
walls of various homeless shelters and service organizations that serve 
homeless adults. The other is a half-sheet (8 ½” x 5 ½”) flyer that is handed 
to individuals expressing an interest in the study at the various homeless 
shelters and service organizations that serve homeless adults (as listed in 
12.1 above). 
12.5 Payment:  
Participants are compensated at each study visit they attend. Compensation 
varies depending on the time the visit is expected to take and the data that is 
collected at that visit. Compensation includes gift cards (Visa and/or 
American Express) and small incentives. Incentives include bus tokens, 
backpacks, pocket calendars, water bottles, note pads, word find book 
games, Subway gift cards ($5), and playing cards. Participants are also 
offered a raffle draw during the first 12 weeks of the study when the study 
treatment (nicotine replacement treatment) is administered and at weeks 16 


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Revised: April 19, 2017 
and 26 when alcohol use is assessed. Raffle prizes include bus tokens (50 
chances), $5 Subway gift cards (40 chances) and $10 gift cards (10 
chances). Compensation is given at the end of each study visit the 
participant attends. Over the course of the study participants can earn up to 
$285 in Visa or American Express gift cards and incentives valued at up to 
$145 for a total of $430 in total compensation in addition to small raffle 
winnings. Payments are given only to the study participant, and there are no 
research experience points awarded. 
13.0 Withdrawal of Participants 
13.1 Withdrawal Circumstances: 
Participants may be withdrawn from the research without their consent if 
they harass or otherwise intimidate staff with threats of physical or sexual 
violence. 
13.2 Withdrawal Procedures: 
Participants may voluntarily withdraw from the study if they find they are 
no longer interested in participating or if they will otherwise be unable to 
continue participation. Those who voluntarily withdraw can return and 
continue their participation at any point in the future during the 26 week 
study period. For example, a participant may leave the area for a job, family, 
or other reason but return and continue participation. When returning, they 
will re-enter the study at the week they would be at if they had participated 
continuously. Each study visit has a window of time before and after the 
ideal date of their visit. Study visits can only be completed during the visit 
window.   
13.3 Termination Procedures: 
There is not a procedure for voluntary withdrawals. Those terminated 
involuntarily are notified in writing at a scheduled meeting to provide the 
written termination letter and any compensation that may be due to them. 
14.0 Risks to Participants 
For each risk or set of risks below, include the procedures to be performed to 
lessen the probability, magnitude, duration, or reversibility of those risks. 
14.1 Foreseeable Risks:  
There are some risks related to quitting smoking that a participant may 
experience while in the study. These may include headaches, being 
uncomfortable, changes in mood, weight gain, and the possibility of going 
back to smoking. Possible side effects of the nicotine patch may include 
skin irritation or rash and problems with sleeping. These are generally mild 
and stop after a few days of using the patch.  
 
Participants are asked by staff at every individual session about side effects 
from the patch or quitting and any health problem that may interfere with 


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their ability to use the patch. Participants are given a specific phone number, 
(612) 625-1850, to report serious side effects and be advised on what to do 
if the patch or anything related to the study makes then uncomfortable.  
 
Use of the nicotine patch will be under supervision of Dr. Okuyemi. 
Participants will be prompted to discuss any side effects during follow-up 
visits and will be given the study office phone number (24-hour coverage) to 
contact study staff and/or the investigators to report adverse events. We 
follow the NIH guidelines for reporting adverse events to the IRB. Any 
problems needing medical attention will be referred to Dr. Okuyemi and the 
Health Care for the homeless clinics in Minneapolis and St. Paul which are 
federally qualified community health centers that provide medical care and 
social services for homeless persons. The patch is discontinued in patients 
who become pregnant or develop a contraindication. Patients are instructed 
not to smoke cigarettes during nicotine treatment therapy. Due to the high 
prevalence of psychiatric and substance abuse co-morbidities in homeless 
populations, in the proposed study we expect to encounter participates who 
have one or more of these co-morbidities. It is also possible after enrolling 
in the study for some participants to develop these co-morbid disorders. 
Counselors are trained to identify such participants and the study 
psychiatrist directly oversees the protocol’s implementation. For each case 
the psychiatrist also makes a determination as to whether the participant is 
mentally stable enough to continue participation in the study. 
 
There are also some risks from stopping alcohol use, however, the study 
screens out heavy alcohol users to avoid enrolling those at risk for 
experiencing alcohol withdrawal. Additionally at every study session 
alcohol use is measured with an alcohol breathalyzer test and the 
administration of the CIWA, an alcohol withdrawal assessment screen to 
ensure a participant is not intoxicated or in alcohol withdrawal. If the CIWA 
indicates an individual is experiencing alcohol withdrawal, study staff walk 
the person to the on-site medical clinic for further evaluation. 
 
14.2 Reproduction Risks: 
Women who are pregnant or breastfeeding are not allowed to enroll in the 
study because of possible harms the nicotine patch could cause to the fetus. 
Women of childbearing age must take a urine pregnancy test to ensure they 
are not pregnant, and if not pregnant must agree to use an effective method 
of preventing pregnancy while using nicotine patch. Women are instructed 
to report to staff should they become pregnant while using the nicotine patch 
and to immediately stop using the patch. 
14.3 Risks to Others: 
N/A 
15.0 Potential Benefits to Participants 


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15.1 Potential Benefits: 
Anticipated benefits of alcohol and tobacco cessation outweigh the minimal risks 
associated with the nicotine replacement therapy and counseling. Given their 
already compromised health status, homeless smokers who abuse alcohol 
are at an extremely high risk of synergistic health effects of tobacco and 
alcohol. Despite this high disease risk, limited empirical data is available 
about how to extend effective smoking cessation and alcohol treatment to 
homeless populations. The current application therefore breaks new ground 
by assessing methods to extend evidence-based treatments to a vulnerable 
population. The prevalence of cigarette smoking among alcohol dependent 
persons is up to 70%, more than three times the rate in general population. 
In addition to high prevalence of tobacco use in homeless populations, the 
rates of alcohol and drug abuse are also high in this population. Cigarette 
smokers drink alcohol more often and more heavily than nonsmokers. 
Studies have shown that the health consequences of chronic alcohol and 
tobacco use are synergistic. In one study of 4,928 alcoholics, the high cancer 
mortality was attributed solely to smoking. Another study by Hurt et al. 
found a 48% cumulative mortality at 20 years after inpatient alcohol 
treatment attributable more to tobacco-related diseases than to alcohol.  
16.0 Data Management 
16.1 Data Analysis Plan: 
The primary analysis will be based on an intention to treat (ITT) analysis, 
i.e., participants will be analyzed in the treatment to which they were 
randomized. The intervention effects for the primary outcomes of week 26 
biochemically verified 7-day abstinence from cigarette smoking (Hyp 1) and 
week 26 90-day abstinence from alcohol consumption (Hyp 2) will be tested 
using Chi-square tests. Any participants lost to follow-up will be classified 
as treatment failures (i.e. smoker or drinker). Bonferroni procedures will be 
used to control for experimentwise Type I error rate. Abstinence rates and 
corresponding 95% confidence intervals will be estimated and summarized 
using appropriate tabular and graphical methods. Supportive analyses will 
examine baseline variables including demographic (age, sex, income, 
education), nicotine dependence, withdrawal symptoms, motivation and 
confidence, self-efficacy, social support, perceived stress, and depressive 
symptoms in terms of their relationship to study outcomes. Analyses 
accounting for these measures will be conducted using multiple logistic 
regression including intervention groups as controlled factors. Thus we can 
assess whether the main conclusions from the primary analysis are robust 
for the inclusion of these baseline variables. For hypothesis 3, Fisher exact 
test will be used to compare the biochemically verified 7-day smoking 
abstinence rates at week 26 follow-up between the participants who receive 
the Intensive Smoking intervention (IS) and participants who receive Usual 
Care (UC). Supportive analysis will be conducted using multiple logistic 
regression including the intervention group as predictor adjusting baseline 
covariates to assess whether the result from secondary analysis is robust for 


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the inclusion of baseline covariates. Analyses for exploratory aims: To 
examine how smoking cessation, alcohol abstinence, smoking reduction, 
and alcohol reduction at weeks 12, 26, and 52 follow-up relate to the 
psychosocial factors, such as level of depression, hopelessness, and 
perceived stress, other substance abuse, opportunities for employment and 
housing and overall health, separate repeated measures logistic regressions 
with generalized estimating equations (GEE) or linear mixed models that 
accounts for the repeated measures structure of the data will be used to 
examine the associations between each individual psychosocial predictors 
and smoking or alcohol outcomes at weeks 12, 26, and 52 follow-ups. 
Interactions terms between these factors and intervention indicators will be 
further tested in the above models. Model validation will use analytic and 
graphical techniques to check assumptions of linearity, homoscedasticity, 
multivariate normality, and independence of residuals. Descriptive statistics 
will be used to summarize and ANOVA or Chi-square tests will be used to 
examine participants’ perceptions of acceptability and usefulness of 
components of the various interventions. 
16.2 Power Analysis: 
We will enroll 15% more than the calculated sample size to accommodate a higher attrition than that from PTQ1.  
 
Usual 
Care 
(UC) 
Integrated 
Smoking 
and Alcohol 
Intervention 
(IS+A) 
n=284/arm 
N=645 
need to be 
enrolled 
n=260/arm 
N = 600 
need to be 
enrolled 
n=239/arm 
N=550 
need to be 
enrolled 
n=217/arm 
N = 500 
need to be 
enrolled 
n=195/arm 
N=450 need 
to be 
enrolled 
n=173/arm 
N = 400 
need to be 
enrolled 
 
Abstinence rates from 
cigarettes smoking 
(Hypothesis 1) 
Power for Hypothesis 1: IS+A vs. UC 
(α = 0.025) 
Target 
Scenario 
4% 
18% 
99% 
99% 
99% 
99% 
98% 
97% 
Other 
Scenarios 
4% 
16% 
99% 
99% 
98% 
97% 
95% 
93% 
4% 
14% 
97% 
96% 
94% 
91% 
87% 
82% 
4% 
12% 
88% 
85% 
82% 
77% 
71% 
64% 
 
Abstinence rates from 
alcohol (Hypothesis 2) 
Power for Hypothesis 2: IS+A vs. UC 
(α = 0.025) 
Target 
Scenario 
10% 
32% 
99% 
99% 
99% 
99% 
99% 
99% 
Other 
Scenarios 
10% 
21% 
90% 
87% 
84% 
79% 
74% 
68% 
10% 
19% 
76% 
71% 
67% 
62% 
56% 
50% 
 
16.3 Data Integrity: 
Participant enrollment, study participation, and retention are tracked on an 
Excel spreadsheet as well as in REDCap, the study database. All eligibility 
screening forms are completed on paper and then entered into the REDCap 
database. Participant data is entered into a REDCap database from both 
paper forms completed at the beginning of the study and from direct data 
entry in the field during study visits. The spreadsheet and REDCap are 
regularly reconciled for quality control.  


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17.0 Confidentiality 
17.1 Data Security: 
Data will be stored in REDCap databases.  Data for this study will be 
entered into interactive, relational REDCap databases, which use a MySQL 
database via a secure web interface with data checks used during data entry 
to ensure data quality. REDCap includes a complete suite of features to 
support HIPAA compliance, including a full audit trail, user-based 
privileges, and integration with the institutional LDAP server. The MySQL 
database and the web server will both be housed on secure servers operated 
by the University of Minnesota Academic Health Center’s Information 
Systems group (AHC-IS). The servers are in a physically secure location on 
campus and are backed up nightly, with the backups stored in accordance 
with the AHC-IS retention schedule of daily, weekly, and monthly tapes 
retained for 1 month, 3 months, and 6 months, respectively. Weekly backup 
tapes are stored offsite. The AHC-IS servers provide a stable, secure, well-
maintained, and high-capacity data storage environment, and both REDCap 
and MySQL are widely-used, powerful, reliable, well-supported systems. 
Access to the study's data in REDCap will be restricted to the members of 
the study team by username and password. 
Consent forms or other study information will not be placed in any 
participant medical, employment or education records.. 
18.0 Provisions to Monitor the Data to Ensure the Safety of 
Participants 
18.1 Data Integrity Monitoring.  
A Data Safely Monitoring Board (DSMB) was established in 
January 2016. The first meeting was held in April 2106. The 
qualification for members includes research knowledge and 
experience with tobacco cessation, homeless adults, health 
disparities with vulnerable and underserved populations and 
statistical methodologies. Members were selected based on these 
qualifications, their interest, and their availability to attend meetings 
and review data. 
DSMB members determine the frequency of meetings based on the 
reports provided them. Each report contains a detailed recruitment 
update that includes current enrollment and recruitment, consort 
diagram, and a target vs. actual recruitment chart; a description of 
the study sample by treatment group; a safety assessment including 
adverse events and serious adverse events by treatment group; a data 
collection update including counseling treatment visits and weekly 
visits by treatment group; and a list of protocol violations. 
DSMB members monitor enrollment numbers and review blinded treatment 
data to ensure significant sample size and when necessary, to propose design 


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changes to ensure significant outcomes. Monitoring is accomplished through 
regular meetings to share data to understand any enrollment, participant 
safety, or unforeseen issues affecting study outcomes and deadlines that may 
require design, endpoints or outcomes. The monitors are responsible to 
review the data and propose sustainable solutions to maintain the research 
goals and outcomes. The reports compiled for DSMB members are shared 
with co-investigators with treatment group data blinded. 
Data Safety Monitoring.  
Study participants are asked to report any adverse events they have 
experienced during their study participation at each study visit. Participants 
are asked if they were hospitalized or sought emergency medical care since 
their last visit. All hospitalizations and emergency room visits and the 
reason are recorded and paper by the study team and entered into REDCap, 
the study database. The study PI, a medical doctor with extensive tobacco 
cessation research experience, reviews all adverse events. All adverse events 
and serious adverse events are regularly report to the DSMB as noted above 
after a review by the study statistician to ensure if any harms are occurring. 
Currently there are no identified conditions that could trigger an immediate 
suspension of work. Nicotine replacement products have been on the market 
and proven to be safe for a number of years. This is the second phase of a 
study in the same population where no serious safety issues have occurred. 
19.0 Provisions to Protect the Privacy Interests of Participants 
19.1 Protecting Privacy: 
All participant contact is conducted by trained research staff and occurs in a 
private office or a dedicated space that affords participant privacy. 
19.2 Access to Participants: 
The research does not involve collecting data from any kind of participant 
record. 
20.0 Compensation for Research-Related Injury 
20.1 Compensation for Research-Related Injury: 
N/A. 
20.2 Contract Language: 
N/A. 
21.0 Consent Process 
21.1 Consent Process (when consent will be obtained): 
Consent will take place at homeless shelters and service organizations 
serving homeless adults. After completing the eligibility survey prospective 
participants will be notified of their eligibility and scheduled to enroll at the 
next available study visit. Participants are assessed at every study visit for 


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ability to participate. All participants take an alcohol breathalyzer test at 
every study visit and must test below .08 in order to complete the study 
visit. Participants are also assessed at every study visit for cognition and for 
suicidal ideation. Staff assess for incoherence, disorganized speech, or 
marked loosening of associations and administer the Short Blessed Test if 
concerned. If the participant does not pass the Short Blessed Test, they are 
rescheduled. Consent is obtained in writing.  
21.2 Waiver or Alteration of Consent Process (when consent will not be 
obtained):  
N/A 
21.3 Non-English Speaking Participants: 
Non-English speakers are not enrolled in the study. 
21.4  Participants Who Are Not Yet Adults (infants, children, teenagers under 18 
years of age): 
Individuals must be at least 18 years old to enroll. 
21.5 Cognitively Impaired Adults, or adults with fluctuating or diminished 
capacity to consent: 
All participants take an alcohol breathalyzer test at every study visit and 
must test below .08 in order to complete the study visit. Participants are also 
assessed at every study visit for cognition and for suicidal ideation. Staff 
assess for incoherence, disorganized speech, or marked loosening of 
associations and administer the Short Blessed Test if concerned. If the 
participant does not pass the Short Blessed Test, they are rescheduled.  
21.6 Adults Unable to Consent: 
N/A  
22.0 Setting 
22.1 Research Sites: 
As noted in other sections above, study participants are recruited from 
homeless shelters and facilities in the Minneapolis/St Paul area that serve 
homeless adults. Homeless shelters include Dorothy Day Center, Salvation 
Army Harbor Light, United Gospel Mission, Naomi Family Center, Emma 
Norton Center, Our Savior’s Shelter, St. Stephen’s Shelter, and Simpson 
House. Organizations serving homeless adults include the Catholic Charities 
Opportunity Centers, Listening House, the Veteran’s Service Center, 
Hennepin and Ramsey County detoxification centers, Sharing and Caring 
Hands, Higher Ground and the Hennepin County Healthcare for the 
Homeless program. All research procedures are performed at the sites. 
23.0 Multi-Site Research 
N/A 


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24.0 Resources Available 
24.1 Resources Available: 
The study does not have a student investigator. The feasibility of the 
recruiting numbers was determined by the results of the PTQ I study. 
However, we have found it necessary to adjust the original proposed 
numbers due to a large number of individuals unable to meet the criteria for 
alcohol use. The new numbers were calculated by the study statistician, the 
NIH project officer and the DSMB. The study began enrolling participants 
in January 2015 and expect to complete enrollment at the end of March 
2018 which leaves and additional year for follow-up, data cleaning and 
analysis and development of manuscripts. 
The study staff conduct the research in homeless shelters and service 
organizations in Minneapolis and St Paul. When not working in the shelters, 
they work from study offices at UROC in Minneapolis and a commercial 
site in downtown St Paul, both of which are close to the two primary 
homeless shelters serving large number of homeless adults. All study sites 
have medical and psychological services available onsite through Healthcare 
for the Homeless. Staff also carry referral information for Hennepin and 
Ramsey county crisis hotlines and the national suicide hotline for 
participants who screen for suicidal ideation. The study psychiatrist is on-
call for telephone consultations and the study has written procedures for 
calling emergency services if the on-site healthcare clinic is unable or 
unavailable to assist. 
 
New staff complete all required trainings before working on the study and 
read the study procedures and become familiar with the study data 
collection forms and tools. Once in the field with the study team, they 
observe how the study is conducted first and then are trained to administer 
the study surveys. The study team observes new staff in administering 
surveys until they are determined to be proficient and able to conduct the 
field work without supervision. The study team meets weekly to discuss 
study issues and to review protocols and procedures to ensure fidelity to the 
protocol. 
 
25.0 References 
Include references to any scholarly articles or other materials used to discuss the 
background for the study or to justify any proposed procedures. 

ICF_001.pdf: 
IRB Code # 1307M39761 
Version Date: 4.17.17 
1 of 6 
 
Enhancing Smoking Cessation in Homeless Populations  
Consent Form 
NCT01932996 
 
 
You are invited to participate in a smoking cessation study. You were selected as a possible 
participant because you indicated that you smoke cigarettes and that you do not have a permanent 
residence. We ask that you read this form and ask any questions you may have before agreeing to be 
in the study. 
 
This study is being conducted by Dr. Rebekah Pratt, PhD in the Program for Health Disparities 
Research at the University of Minnesota, Twin Cities. It is funded by the National Institutes of 
Health.  
 
 
Study Purpose 
 
The purpose of the study is to test which therapies are most effective in helping homeless people 
quit smoking. This study will look at two different treatments: 1) Counseling to help quit smoking 
and drinking alcohol using Cognitive Behavioral Therapy, and 2) Brief counseling on quitting 
smoking and alcohol. Cognitive Behavioral Therapy is a type of therapy that focuses on 
understanding the thoughts and feelings that influence behaviors. It is commonly used to treat a 
wide range of disorders including addictions such as smoking cigarettes. Trying the two treatments 
will show if using Cognitive Behavioral Therapy is helpful, and if trying to quit smoking at the 
same time as drinking proves to be beneficial. All participants will additionally receive 12-week 
treatment with nicotine patch plus nicotine gum/lozenge (nicotine replacement therapy). 
 
 
Study Procedures 
 
If you agree to participate in this study, you will be assigned by chance (like flipping a coin) to one 
of the two groups that are currently open for study participants: 
 Group A will receive brief smoking and alcohol counseling  
 Group B will receive brief alcohol counseling plus smoking counseling using Cognitive 
Behavioral Therapy (closed for enrollment) 
 Group C will receive smoking and alcohol counseling using Cognitive Behavioral 
Therapy  
 
No matter what group you are in, you will be asked to meet individually with research staff for a 
total of 17 times over the 6 months that the study will last. These meetings will take place at 
homeless shelters in the Twin Cities metro area. Efforts will be made to have the meetings in 
shelters that would be convenient for you. The first visit at week 0 will last up to 90 minutes while 
most other visits will last 30-60 minutes depending on which group you are assigned to. At weeks 
16 and 26, the visits will also be 90 minutes long. Additionally, you may be asked to participate in 
an interview at week 26 to answers questions about your study experience. A study calendar is 
located on the last page of this form.  


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Screening Visit 
 
At the first individual session you will be asked questions about your smoking and drinking history, 
your living situation, and background. If you are a woman who is able to get pregnant, you will be 
asked to take a pregnancy test. A saliva sample which tests for cotinine, a substance in your system 
when you use nicotine, will also be collected to verify your smoking status.  You will be asked to 
use a cotton swab to collect saliva in your mouth; the swab will be placed in a study tube and 
carefully stored in the study freezer.  
 
 
Baseline Visit 
 
You will return for a visit where you will be assigned to one of the two groups listed above. You 
will then answer questions about your smoking and drinking history, as well as the following topics: 
 Your height and weight  
 Your recent history of substance abuse  
 Your urges to smoke and drink  
 Your motivation and confidence to quit 
 Groups A & C will receive a complimentary package of nicotine patches  
 
 
Individual Sessions 
 
At all individual sessions you will be asked to take an alcohol breathalyzer test. If your result is 
greater than the legal limit, 0.08%, we will be unable to complete the study visit and will need to 
reschedule.  At these visits you will also be asked to answer questions about your cigarette smoking 
and use of alcohol and other drugs. Several questions will be asked about your mental health history 
and current thoughts and feelings. 
 
At every session you will take a carbon monoxide test. Carbon monoxide is a gas in cigarette smoke 
that is also in the air smokers breathe out from their lungs. To do this test, you will need to blow 
into a cardboard tube that is attached to a handheld device and portable machine. The machine will 
measure the amount of carbon monoxide in the air that you exhale.  
  
Additionally, you will be asked questions about your smoking and drinking patterns and cravings at 
each visit, as well as your health beliefs and behaviors. You may be asked to keep a log, to help you 
remember when you had urges to smoke or drink, and what you did to address those urges.  
 
At some visits, trained health professionals will conduct interviews, to see how your quitting 
process is going. They will ask you about: 
 Your withdrawal symptoms 
 Your urge to smoke  
 Your urge to drink alcohol  
 


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You also agree to be audio-recorded during counseling sessions for supervision and education of 
staff, as well as ongoing quality control and improvement purposes.  The audio recordings will be 
destroyed 5 years after the end of the study.  
 
A member of the research staff will also be in contact with you regularly to remind you of your 
appointments, replace lost nicotine patches, gum or lozenge, or answer questions you may have 
between sessions. In order to remind you of appointments, to make sure you get refills on the 
nicotine replacement therapy, and that you are using the patch correctly, program staff may need to 
talk with other homeless service providers, such as a case worker or shelter director, about your 
current contact information.  
 
If you do not follow the instructions outlined above, you may be asked to withdraw from this study. 
By signing this form you agree to return any unused patches, gum or lozenges at the end of the 
treatment phase of the study.  
 
Week 26 Interview 
If you are contacted to participate in the additional interview about your study experience at week 
26, you have the option to decline the interview. If you chose to do the interview, your interview 
will be audio-recorded. The audio recording will not contain any personally identifying information 
and will be destroyed 5 years after the end of the study. You will be compensated with a $20 Visa 
gift card. 
 
Risks of Study Participation 
 
There are some risks related to quitting smoking that you may experience while in the study. These 
may include headaches, being uncomfortable, changes in mood, weight gain, and the possibility of 
going back to smoking. The nicotine replacement therapy used in this study may include the 
nicotine patch, nicotine gum or nicotine lozenge.  You should not use the nicotine patch if you have 
irregular heartbeats, or have had a heart attack of stroke in the previous month.  Possible side effects 
of the nicotine patch may include skin irritation or rash, problems with sleeping, feeling/being sick, 
headache and dizziness.  You may also experience nervousness, trembling, shortness of breath, 
cough, sore or swollen throat, indigestion, stomach pains, diarrhea, constipation, sweating, dry 
mouth, sore muscles, chest and limb pain, tiredness, weakness, or palpitations (feeling your heart 
beat). These are generally mild and stop after a few days of using the patch.  Possible side effects of 
the nicotine gum or lozenge may include: mouth/teeth/jaw problems, sore throat, coughing, nausea, 
gas or stomach discomfort, headache, heartburn, sweating, or diarrhea. 
 
Abruptly reducing or stopping alcohol use may result in alcohol withdrawal symptoms. Withdrawal 
symptoms could be mild, including insomnia (inadequate sleep), tremors (shaking of hands), 
anxiety (nerves), stomach upset, headache, excessive sweating, or feeling rapid heartbeat 
(palpitations). These mild symptoms may happen within 6-12 hours of stopping alcohol use. 
Abruptly stopping alcohol use may also lead to more moderate or serious symptoms including 
hallucinations (seeing or hearing things that are not real), seizures, delirium (confusion or loss of 
awareness of self, others, and environment), fever, and high blood pressure. More serious alcohol 
withdrawal symptoms may happen up to three days after stopping alcohol use. If these serious 
withdrawal symptoms are not treated, they could lead to death. The timing and severity of 


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withdrawal symptoms vary from person to person depending on the heaviness of alcohol use as well 
as past history of withdrawal symptoms.   
 
You will be asked by staff at every individual session about side effects from the nicotine 
replacement therapy, alcohol-cessation and tobacco-cessation withdrawal symptoms, and any health 
problem that may interfere with your ability to use the nicotine replacement therapy. You can call 
the study phone number, which is (612) 625-1850, to report serious side effects and be advised on 
what to do if the patch, gum, lozenge, or anything related to the study makes you uncomfortable.  
 
 
Pregnancy Risks 
If a woman is pregnant or breastfeeding, she will not be allowed to take part in this study because 
the nicotine patch could harm her baby. Every woman who is able to get pregnant must have a urine 
test to see if she is pregnant. You agree to this test if needed in your case. If you are not pregnant 
and agree to use an effective method of preventing pregnancy while using the nicotine patch, you 
will be allowed to take part in the study. If you become pregnant while in the study and using 
nicotine patch, you should tell the staff and immediately stop using the patch. 
 
 
Benefits of Study Participation 
 
The benefits to study participation are that quitting smoking is one of the best things you can do for 
your health, even if you decide not to be in this study. Your chances of quitting successfully may be 
improved by using nicotine patch. About 1 in 3 people who use the patch are able to quit smoking.  
However, about half of those who quit smoking start again in a year. Your chances of quitting and 
staying quit may be enhanced through counseling. If you quit smoking permanently, within 7 years 
your risk of heart disease will return to the level of a non-smoker. In about 15 years your risk of 
lung cancer will be close to that of a non-smoker. Those who do not quit smoking completely may 
not benefit from being in this study.  
 
 
Alternatives to Study Participation 
 
You do not have to participate in this study. Alternatives to participating in this study are to 
continue smoking, to quit “cold turkey,” to use other quit smoking programs, to buy nicotine 
replacement programs over-the-counter, or to get a prescription for the nicotine inhaler, nicotine 
nasal spray, bupropion (also called Zyban, Wellbutrin) or Varenicline from a doctor.  
 
 
 
Study Costs/Compensation 
 
There will be no direct costs to you associated with participating in this study. The study drug, 
study-related procedures, and study visits will be provided at no charge to you or any insurance 
company. In return for your time and effort, you will receive compensation with a total value of 
approximately $380 during the study or approximately $400 if you are asked and agree to be 
interviewed about your study experience at week 26.You will also be able to draw a prize in a 


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weekly raffle for attending specific study visits. Compensation may include pre-paid gift cards to be 
used at local clothing, shoe or drug stores. Additionally, bus tokens will be available for you to use 
to get to and from your appointments. Please see the Study Calendar for more information. You will 
also receive a 12 week supply of the nicotine patch plus nicotine gum or lozenge. 
 
 
Research Related Injury 
 
In the event that this research activity results in an injury, treatment will be available, including first 
aid, emergency treatment and follow-up care as needed. Care for such injuries will be billed in the 
ordinary manner to you or your insurance company. If you think that you have suffered a research 
related injury, let the study physicians know right away. 
 
 
Confidentiality 
 
The records of this study will be kept private. In any publications or presentations, we will not 
include any information that will make it possible to identify you as a subject. Your record for the 
study may, however, be reviewed by the National Institutes of Health, representatives of the Food 
and Drug Administration (FDA), and by departments at the University with appropriate regulatory 
oversight. Study information will not be recorded in your medical records. To these extents, 
confidentiality is not absolute. Study data will be encrypted according to current University policy 
for protection of confidentiality.    
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. law. This Web site will not include information that could identify you. At most, the Website 
will include a summary of the results. You can search this Website at any time. 
 
Finally, if we have information indicating you are at risk for harming yourself or others, or you tell 
us about a specific child who is being abused, we will have to report this information to the proper 
authorities to keep you and others safe. 
 
 
Protected Health Information (PHI) 
 
Your PHI created or received for the purposes of this study is protected under the federal regulation 
known as HIPAA. Refer to the attached HIPAA authorization for details concerning the use of this 
information.  
 
 
Voluntary Nature of the Study 
 
Participation in this study is voluntary. Your decision whether or not to participate in this study will 
not affect your current or future relations with the University of Minnesota, the University of 
Minnesota Medical Center, Fairview, any shelters or social service providers. If you decide to 
participate, you are free to withdraw at any time without affecting those relationships.   


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Contacts and Questions 
 
The researchers conducting this study are Drs. Kolawole Okuyemi, Anne Joseph, Janet Thomas, 
Susan Everson-Rose, Nancy Raymond, and Rebekah Pratt.  You may ask any questions you have 
now, or if you have questions later, you are encouraged to contact them at (612) 625-1654. 
 
To share feedback privately about your research experience, including any concerns about the 
study, call the Research Participants Advocate Line: 612-625-1650or give feedback online 
at www.irb.umn.edu/report.html. You may also contact the Human Research Protection Program in 
writing at D528 Mayo, 420 Delaware St. Southeast, Minneapolis, Minnesota 55455. 
 
You will be given a copy of this form to keep for your records. 
 
Statement of Consent 
I have read the above information. I have asked questions and have received answers. I consent to 
participate in the study. 
 
 
 
________________________________________ 
Printed name of study participant 
 
 
_________________________________________     ______________ 
_____________ 
Signature of study participant 
Date of signature 
Time (if needed)* 
 
 
 
 
____________________________________ 
 
 
 
Printed Name of the Person Conducting the 
Consent Discussion  
 
 
 
_____________________________________ 
______________ 
_____________ 
Signature of the Person Conducting the  
Date of signature 
Time (if needed)* 
 
Consent Discussion† 
 
 
* Time is needed only if information was provided and consent is given on the same day, or if consent is given and any study-specific activities will 
be performed on the same day. 
 
†The investigator, or a suitably qualified and trained person designated by the investigator to conduct the informed consent process, must sign and date 
the form at the same time as the subject.