Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention
Condition: Smoking Cessation
Intervention: Group Cognitive Behavioral Therapy; General Health Education; Transdermal Nicotine Patch
Intervention description: 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.; 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).; 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.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 356.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        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)