Clinical trial NCT02511236
Conditions: Smoking Cessation
Sponsor: University of Miami
Start date: 2015-08-01; Completion date: 2019-10-23
Enrollment: 356 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the effects of a group smoking cessation program. The study will also examine individual differences in response to the intervention program.

Detailed description:

Arms: arm 1: Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\]. arm 2: Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].
Interventions: intervention 1: Group Cognitive Behavioral Therapy intervention 2: General Health Education intervention 3: Transdermal Nicotine Patch
Intervention descriptions: intervention 1: The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include a functional analysis of smoking patterns, environmental cues, and motivation for change, and cover nicotine addiction and withdrawal, health consequences, benefits of cessation, stress management, negative affect, alcohol use, triggers, coping responses, cognitive restructuring, social support, decision making, weight control, and physical activity. intervention 2: The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include didactic information on tobacco-associated morbidities, such as heart disease, diabetes, and hypertension. Content may include Power Point-delivered lectures on the prevalence, etiology, basic pathology, symptom patterns, and treatment of the conditions, and discussion questions designed to facilitate learning and interest. Smoking cessation specific topics will not be addressed, and coping skills will not be provided. Participants will be allowed to share feelings regarding smoking (if they mention them) and general questions will be answered, although no specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere to the TNP protocol). intervention 3: Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations.

Protocol documents:
Prot_SAP_000.pdf: 
IRB Study Number: 20150356 
Version 7, Date 10/11/2018 
NCT02511236 
 
1) 
Protocol Title 
 
Addressing Tobacco Health Disparities via Group Intervention 
 
2) 
Objectives* 
 
Purposes and aims: (1) Examine the effects of CBT for smoking cessation on perceived 
stress and depressive symptoms in a racially/ethnically diverse sample; (2) test the 
efficacy of CBT for eliminating smoking cessation disparities; and (3) Examine 
physiological distress as an underlying mechanism for the effects of CBT on racial/ethnic 
minority smokers (exploratory). 
 
3) 
Background* 
 
Significance: Tobacco smoking is robustly associated with significant morbidity and 
mortality, from conditions such as cancer, diabetes, cardiovascular disease, and 
hypertension. Pervasive smoking-related health disparities exist across racial/ethnic and 
socioeconomic status (SES) groups. The most established disparities are observed in 
comparisons of African Americans and Whites, though evidence demonstrates disparities 
across populations of smokers. 
 
The importance of reducing tobacco-associated health disparities between cannot be 
understated. Racial/ethnic minority smokers are less likely to quit successfully, even in the 
context of treatment. Perceived stress and depressive symptoms are known barriers to 
smoking cessation, yet have virtually been ignored in the disparities literature. 
Racial/ethnic minority smokers tend to have elevated distress levels, which may contribute 
to disparities in cessation and health. Cognitive behavioral therapy (CBT) for cessation 
addresses these concerns and has the potential to reduce or eliminate disparities. Our 
preliminary studies, conducted in our established research clinic, found race/ethnic 
differences in baseline perceived stress and depressive symptoms. Following CBT, these 
differences were no longer present. Moreover, the lack of disparity in cessation appeared to 
be driven by the positive change in stress and depressive symptoms. This study will be the 
first RCT to test the impact of CBT on smoking cessation disparities. 
 
4) 
Inclusion and Exclusion Criteria* 
Inclusion criteria for this study include: (1) self-identify as African 
American/Black, Hispanic (any race), or White non-Hispanic; (2) smoke at least 5 
cigarettes/day or CO reading of at least 8 ppm; (3) be over age 18; and (4) 
speak/read English and/or Spanish. 
Exclusion criteria include: (1) contraindications for transdermal nicotine patch 
therapy (TNP); (2) cognitive or mental health impairment that inhibits group 
treatment; (3) currently being treated for smoking cessation, alcoholism, or illicit 
drug use; (4) unable to attend sessions; (5) indications that participant is not 
appropriate for the study (e.g., aggressive, intoxicated, disruptive, visibly ill); (6) 
does not self-identify as African American, Hispanic, or White (non-Hispanic). 


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Withdrawal of Subjects 
The following are reasons for withdrawal of subjects from the study: 
• A subject does not meet the eligibility criteria, (the subject will be considered a 
screen failure).   
• A subject withdraws informed consent. 
• A subject dies during protocol participation or  
• A study investigator decides the subject should be withdrawn from the study (e.g. 
subject non-compliance)  
Regardless of reason for withdrawal, once a subject has been randomized to a study 
arm, an intention to treat analysis will be performed.  
 
Procedures Involved 
This behavioral intervention study includes a baseline assessment, randomization to one of 
two conditions, and 4 subsequent assessments. Screening may occur in person or over the 
telephone. Eligible participants may be scheduled for an appointment to attend 
orientation/baseline assessment. Time permitting prior to the appointment, we may attempt 
to mail a confirmation letter and/or complete reminder contacts (telephone calls, text 
messages, email) leading up to the appointments.  
 
Assessments. At the baseline visit, eligible participants will provide written informed 
consent, and complete some or all of the baseline measures (described below). They may 
also be asked to complete intra-treatment assessments during the 8 sessions. Follow-up 
assessments (called “reunions”) may occur at the end-of-therapy (EOT), and 3, 6, and 12-
month follow-ups. The full assessment (at baseline) may require approximately 90 minutes 
to complete. Intra-treatment assessments may require 5 minutes, and follow-ups may 
require 60 minutes. The questionnaires may be completed (fully or in part) electronically 
using iPads/computers or on paper. Skip patterns may be built into the measures to 
decrease participant burden. All items are voluntary, thus participants may select an answer 
for each item before moving forward, and will have the option of selecting ‘I would rather 
not say’ on the electronic version or skipping items as desired. Surveys in either electronic 
or paper format will use identification numbers rather than identifying information.  
 
Participants may complete some or all of the following measures: 
Questionnaires: A standard demographic questionnaire assessing race, ethnicity, nativity, 
age, education, employment status, health insurance, marital status, and number of 
children. Measures may also include current medications, medical history (e.g., diabetes, 
hypertension, chronic back pain, arthritis, emphysema, and asthma), height, weight, 
smoking history, nicotine dependence, readiness to quit smoking, perceived stress, 
depressive symptoms, alcohol use, ethnic discrimination, nicotine withdrawal and urges to 
smoke, social support, daily hassles, e-cigarette use, sleep quality, intervention evaluations, 
group cohesion, smoking pattern, history of substance dependence and treatment, and use 
of other tobacco products and pharmacotherapies. 
 
Bio-verification: Saliva cotinine levels may be assessed at baseline, and to confirm self-
reported cessation at the 3, 6, and 12-month follow-ups. Research staff will be trained in 
the U.S. Centers for Disease Control (CDC) guidelines for transport of biological 


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specimens within the United States. The CBT intervention includes carbon monoxide (CO) 
testing at each treatment session to provide immediate feedback to participants regarding 
the benefits of cessation.  
 
Salivary cortisol: At each assessment point, we may collect saliva samples for cortisol 
analyses. Participants who agree will be provided with the needed materials and trained in 
saliva collection procedures at orientation and prior to assessments. They may be asked to 
collect saliva up to 4 times throughout the day. Saliva samples will be stored in the lab 
freezers. At the time of collection, we will ask participants to record hours of sleep, food 
consumption, and exercise within the past hour. 
 
Randomization. Participants may be randomly assigned to one of 2 conditions. In the first 
condition, Group Cognitive Behavioral Therapy for Smoking Cessation (CBT), participants 
may receive 8 group sessions and eight weeks of TNP [21mg (4 weeks), 14mg (2 weeks), 
and 7mg (2 weeks)]. The four-week CBT protocol includes 4 sessions during week 1, 2 
sessions during week 2, 1 session during week 3, and 1 session during week 4. We will 
request that participants attend every session; however, we recognize that this will not 
always be feasible. CBT is intended to guide participants through the cessation process and 
teach relapse prevention skills. Sessions may include a functional analysis of smoking 
patterns, environmental cues, and motivation for change, and cover nicotine addiction and 
withdrawal, health consequences, benefits of cessation, stress management, negative affect, 
alcohol use, triggers, coping responses, cognitive restructuring, social support, decision 
making, weight control, and physical activity.  In the second condition, General Health 
Education, participants may receive sessions including didactic information on tobacco-
associated morbidities, such as heart disease, diabetes, and hypertension. Content may 
include PowerPoint-delivered lectures on the prevalence, etiology, basic pathology, 
symptom patterns, and treatment of the conditions, and discussion questions designed to 
facilitate learning and interest. Smoking cessation specific topics will not be addressed, and 
coping skills will not be provided. Participants will be allowed to share feelings regarding 
smoking (if they mention them) and general questions will be answered, although no 
specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere 
to the TNP protocol). The groups in both conditions are expected to require 90-120 
minutes, depending on group size. Sessions may be audio or video taped.  
 
Participants will be paid for completing assessments, baseline ($20), EOT ($30), 3-month 
($40.00), 6-month ($50.00), and12-month ($50.00), prorated by half for incomplete 
assessments. Funds permitting, participants may also receive reimbursement for 
transportation and light refreshments during visits. We anticipate that data collection may 
occur within a 4-year period, although this may vary depending on recruitment progress.    
  
5) 
Data and Specimen Banking* 
 
N/A 
 
6) 
Data Management* 
Statistical Analysis 
Descriptive statistics such as frequencies, percentages, means, medians, standard 
deviations, and interquartile ranges may be tabulated to describe the study sample. 


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Associations between variables and intervention effects may be assessed with 
Wilcoxon/Kruskal-Wallis tests, Chi-squared/Fisher exact tests, analyses of variance, 
multiple regression, generalized linear mixed models, and logistic regression.  
 
Data may be collected using the University of Miami Qualtrics survey program and stored 
on password-protected university servers. Surveys collected on paper will be entered by 
members of the research team into password protected data files. Access to the files 
containing the survey and survey responses is restricted and only study personnel will be 
given access to these files. Identifying information will not be collected with electronic or 
paper questionnaires. Data published from this survey will be presented in group form, so 
that individual participant data is not identifiable. Data may be stored for up to five years 
following publication of findings.  
 
Guidelines for Adverse Events (AEs) and Smoking Cessation Rates 
We anticipate few adverse events due to study participation. Abstinence from smoking may 
lead to withdrawal symptoms, including irritability, anxiety, restlessness, sadness, and 
difficulty concentrating. These symptoms are expected and manageable and most resolve in 
two to six weeks in abstinent smokers. Withdrawal can be attenuated by the use of nicotine 
replacement therapy (NRT). The NRT to be administered in this study is FDA-approved 
and has demonstrated adverse side effects in only a minority of users. To ensure the safety 
of subjects, any persons who report adverse side effects from NRT will be advised to 
discontinue use and encouraged to visit their private doctor or referred to the emergency 
room. Any persons who report problematic nicotine withdrawal (e.g., depression) will be 
assessed for severity by the Dr. Antoni, who is a clinical psychologist. If the participant’s 
depression is greater than that expected due to typical nicotine withdrawal or is causing 
significant impairment in functioning, the subject will be referred for services at the 
Psychological Services Center—the Psychology Department’s on-campus training clinic, 
or to a community mental health provider. In the case of serious adverse events (SAEs) or 
other untoward occurrence, the PI will notify the Data and Safety Monitoring Committee 
(DSMC), the Office of Research, and the IRB via telephone at the time of the incident, 
followed by a detailed written account of the nature and scope of the events and the 
reason(s) for their occurrence.  The activities of the project will be suspended, pending a 
full IRB review. The IRB will follow-up with appropriate action and the research will 
proceed only with written IRB approval. In the event of serious adverse events (SAEs) or 
incidents, the Office of Research and DSMC will take the necessary steps to document the 
events in writing to our regulatory boards. 
SAEs: The DSMC will engage in expedited reviews for any occurrences meeting the FDA 
definition of SAEs – i.e., any fatal event, acute life-threatening event, permanently or 
substantially disabling event, event requiring participant hospitalization, or any congenital 
anomaly. These reviews will determine whether the event poses a significant hazard, side 
effects, or requires precaution. Any SAE will be required to be reported to the DSMC, 
irrespective of its perceived relatedness to the study. Reports will include a description of 
the event and its outcome, related medications, the participant’s medical history and current 
conditions, and all relevant clinical data. Notification by e-mail, and FAX transmittal of 
SAE’s and all related documents will be sent to the DSMC within 2 days of the occurrence. 


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Smoking cessation rates are assessed via Qualtrics at end of counseling (EOC) and follow-
up time points. 
 
7) 
Risks to Subjects* 
 
The risks to subjects, immediate and long range, are considered minimal. Study participants 
will be asked to complete relatively benign questionnaires and before and after receiving 
behavioral treatment plus nicotine replacement for smoking cessation. It is possible that 
subjects might become psychologically distressed while completing questionnaires or be 
dissatisfied with the intervention. They will be provided with transdermal nicotine patches 
that are available over-the-counter and required to indicate whether they have any health 
conditions that may negatively interact with the patches.  
 
To minimize the risk of psychological distress due to questionnaire completion, the 
measures do not contain private or potentially embarrassing items, and are limited to 90 
minutes completion time per assessment. To minimize the risk of dissatisfaction with the 
intervention, we will use an established intervention that has high efficacy. To minimize 
risks associated with the nicotine patches, subjects will be provided with thorough 
education of the indications for the nicotine patch, possible side effects, and known health 
conditions that preclude patch use. The patches are available over the counter; thus, they do 
not pose a significant health risk to most people. They contain minimal amounts of nicotine 
(which are much less than they get from smoking), and are absent the remaining 7,000 
toxins contained in cigarettes. In addition, we will refer patients with a questionable 
medical history to their family physician or to Jackson Memorial Hospital or Tampa 
General (which accept uninsured patients) for consultation.     
 
8) 
Potential Benefits to Subjects* 
 
9) 
Individual subjects can potentially benefit from participating in the study because they may 
be exposed to one of two established smoking cessation treatments plus transdermal 
nicotine patch therapy. Thus, all participants will have the opportunity to make a quit 
attempt and the possibility of long-term smoking cessation. 
This is associated with a number of additional benefits including improved health, 
economic savings, the confidence and happiness associated with becoming an ex-smoker, 
and eliminating the second-hand smoke exposure to others. 
 
10) Vulnerable Populations* 
 
This research study does not include vulnerable populations. 
 
11) Setting 
 
The primary study site is the University of Miami Clinical Research Building, with offices 
on the Miller School of Medicine campus, and in the Flipse building on the Coral Gables 
campus. The Miami site will also recruit participants in Broward County and conduct 
groups at several Broward locations for participant convenience. The second study site is 
the Tobacco, Research, and Intervention Program (TRIP) at the H. Lee Moffitt Cancer 


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Center and Research Institute in Tampa, FL. Participants may also be recruited and 
screened at community events and may be scheduled to come to the lab at a later date. 
Community-based recruitment is intended to diversify the sample, and will reduce barriers 
to on-campus participation. 
 
12) Resources Available 
 
Principal Investigator, David Lee, Ph.D.: Dr. Lee is a tenured Professor in the 
University of Miami Miller School of Medicine, Department of Public Health 
Sciences.  Dr. Lee will contribute his expertise as a chronic disease 
epidemiologist with research interests in tobacco control, SHS exposure, and 
special populations.  Dr. Lee has worked with Hispanics, African-American, and 
low-income youth and adult populations, both nationally and in Florida.  Dr. Lee 
also is a member of the SCCC and Cancer Control Program.  He also serves as the 
Principal Director of the Florida Cancer Data System Cancer Registry, leading to 
the recent publication of a comprehensive monograph on the cancer experience of 
Florida Hispanics, including major tobacco associated cancers.  He has been 
involved in tobacco research for over 19 years and has directed studies employing 
both cross-sectional and longitudinal cohort designs.  Dr. Lee has been the 
Principal Investigator in six NIH-supported studies and on three grants examining 
the health effects of SHS awarded by the Flight Attendant Medical Research 
Institute (FAMRI), the primary funding organization for SHS in the United States.  
His most recent FAMRI supported grant is examining associations of self-
reported telephone survey data with biologically confirmed SHS exposure and 
health outcomes in a diverse sample of Florida adults.  Dr. Lee was a Co-
Investigator for the Hispanic Community Health Study where tobacco was one of 
the primary outcome variables.  Dr. Lee served as Project Director for the Team 
Science Program working to “Reduce the Burden of Tobacco-Associated Cancers 
in Florida.”  Dr. Lee’s publications have appeared in highly rated peer reviewed 
journals, such as Tobacco Control, the American Journal of Public Health, and 
Nicotine and Tobacco Research.  Dr. Lee’s publication, “Respiratory Effects of 
SHS Exposure Among Young Adults Residing in a ‘Clean’ Indoor Air State” was 
distributed worldwide to tobacco control experts via GLOBALink.   
13) Prior Approvals 
 
This survey does not require additional approvals prior to commencing the research. 
 
14) Recruitment Methods 
 
Participant recruitment may occur using several methods, including radio and newspaper 
stories and advertisements, community events (e.g., health fairs), neighborhood canvassing, 
email, online social-media and advertising sites, and flyers and post-cards distributed 
throughout the community (e.g., churches, Laundromats, businesses, physicians’ offices, 
health centers/clinics). Recruitment may also take place at other medical sites (e.g., 
Broward Health organization, and UHealth regional sites) through patient referrals, 
community outreach, or direct referrals to the Research staff. After calling the telephone 


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number provided in the advertisements or being identified in person, RAs may explain the 
study to participants (paraphrasing from a script) and conduct screening for eligibility.  
 
Participants may be given small tokens of appreciation, such as water bottles, wallets, or 
bags. 
 
15) Local Number of Subjects 
We anticipate screening up to 1000 subjects and enrolling up to 500 to complete the 
study.  Moffitt Cancer Center will enroll 150 subjects.  Moffitt’s enrollment 
numbers are not included in this protocol, being as it is stated in their own IRB 
protocol. 
16) Confidentiality 
 
Contact information for participants scheduling appointments to participate on site may be 
recorded over the telephone and stored in a password encrypted database. Following study 
completion, contact information may be deleted from the database. Only the PI and study 
personnel may have access to the database. Survey data may be collected and stored on 
University of Miami and H. Lee Moffitt Cancer Center password protected servers using 
electronic survey software. Assessment responses will not include identifying information. 
Only select study personnel may have administrative access to the survey data. Personnel 
with access must log onto the system with a username and password. Data may be 
maintained for five years post study publication. 
 
17) Provisions to Protect the Privacy Interests of Subjects 
 
Study participation is completely voluntary and confidential, which is explained during the 
informed consent process. Several RAs will recruit, schedule, and collect information from 
participants. They may elect to interact with (or not) any of the study staff. The 
questionnaires may be self-administered; however staff will be available to assist 
participants as needed. If desired and space-permitting, participants may be allowed to 
complete the assessment in private. 
 
18) Consent Process 
Participants will undergo screening for enrollment into the study. We are requesting 
a waiver of documentation of consent for this portion only as it is done via phone or 
in person; however, this is minimal risk and consent is not required outside of the 
research setting to ask the screening questions. 
Informed consent may be obtained prior to confirming eligibility to participate in 
the study during the baseline visit. Consent will be obtained by the PI or key 
personnel (trained Research Associates and clinical psychology graduate students).  
 


IRB Study Number: 20150356 
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19) Process to Document Consent in Writing 
 
Participants will be given an informed consent form. Study staff will be available to explain 
the assessments to participants and answer any questions they have about participation. 
Participants will be provided with copies of the consent document. 
 
20) Data & Safety Monitoring Committee Oversight 
 
The Sylvester Comprehensive Cancer Center (SCCC) Data and Safety Monitoring 
Committee (DSMC) will monitor this clinical trial according to the Cancer Center's Data 
and Safety Monitoring Plan (DSMP). In its oversight capacity, the DSMC bears 
responsibility for suspending or terminating this study. 
  
DSMC oversight of the conduct of this trial includes ongoing review of adverse 
event data, and periodic review of self-reported smoking cessation rates.  The guidelines 
appearing in Section #6 are offered for DSMC consideration in assessing adverse events 
and self-reported smoking cessation rates.  In addition, the DSMC will review reports from 
all audits, site visits, or study reviews pertaining to this clinical trial and take appropriate 
action. 
 
21) Monitoring, Auditing, and Inspecting 
The investigator will permit trial-related monitoring, quality audits, and inspections by, 
government regulatory authorities, of all trial-related documents (e.g., source documents, 
regulatory documents, data collection instruments, case report forms).  The investigator 
will ensure the capability for inspections of applicable trial-related facilities.  The 
investigator will ensure that the trial monitor or any other compliance or QA reviewer is 
given access to all trial-related documents and trial-related facilities.   
Participation as an investigator in this trial implies the acceptance of potential inspection 
by government regulatory authorities.  
 
22) Quality Assurance and Quality Control 
In addition to the Clinical Monitoring component of this protocol, Quality Assurance (QA) 
will be implemented to assess compliance with GCP and applicable regulatory 
requirements.  Data or documentation audited shall be assessed for compliance to the 
protocol, accuracy in relation to source documents and compliance to applicable 
regulations. 
 
23) Financing and Insurance 
 
 
Not applicable. 


IRB Study Number: 20150356 
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24) Publications and Data Sharing 
This study will comply with the NIH Data Sharing Policy and Policy on the 
Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials 
Registration and Results Information Submission rule. As such, this trial will be 
registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish 
results in peer-reviewed journals.  Data from this study will be made available upon 
written request 30 days after the publication acceptance of primary study findings. 
De-identified requests will be honored for a period of 3 years of anniversary date by 
contacting principal investigator, David J. Lee.