Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Group Cognitive Behavioral Therapy
* Behavioral: General Health Education
* Drug: Transdermal Nicotine Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identify as African American/Black, Hispanic (any race), or White non-Hispanic Smoke at least 5 cigarettes/day or carbon monoxide (CO) reading of at least 8 ppm be over age 18 speak/read English and/or Spanish Exclusion Criteria: Contraindications for transdermal nicotine patch therapy (TNP) Cognitive or mental health impairment that inhibits group treatment Currently being treated for smoking cessation, alcoholism, or illicit drug use Unable to attend sessions Indications that participant is not appropriate for the study (e.g., aggressive, intoxicated, disruptive, visibly ill) Does not self-identify as African American, Hispanic, or White (non-Hispanic)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Cognitive Behavioral Therapy<br>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)]. | Behavioral: Group Cognitive Behavioral Therapy<br>* 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.<br>Drug: Transdermal Nicotine Patch<br>* 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.<br>* Other names: Nicotine Patch;|
| Active Comparator: General Health Education<br>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)]. | Behavioral: General Health Education<br>* 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).<br>Drug: Transdermal Nicotine Patch<br>* 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.<br>* Other names: Nicotine Patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Reporting 7 Day Point Prevalence Abstinence | Reported will be the number of participants reporting 7 day point prevalence of smoking abstinence | 12-months | 
| Change in Perceived Stress Scores | The Perceived Stress Scale (PSS) is a 10-item questionnaire with scores ranging from 0-40 with higher scores indicated greater stress. | Baseline, 4 weeks | 
| Change in Depressive Symptoms Scores | Depressive scores based on Center for Epidemiologic Studies Depression Scale (CESD). CESD has a total score ranging from 0-60 with a higher score indicating greater depressive symptoms. | Baseline, 4 weeks |