Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

PHASE4CompletedINTERVENTIONAL
Enrollment

356

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

October 23, 2019

Study Completion Date

October 23, 2019

Conditions
Smoking Cessation
Interventions
BEHAVIORAL

Group Cognitive Behavioral Therapy

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.

BEHAVIORAL

General Health Education

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).

DRUG

Transdermal Nicotine Patch

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.

Trial Locations (2)

33124

University of Miami, Coral Gables

33612

H Lee Moffitt Cancer Center, Tampa

All Listed Sponsors
collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

collaborator

James and Esther King Biomedical Research Program

OTHER

lead

University of Miami

OTHER

NCT02511236 - Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention | Biotech Hunter | Biotech Hunter