Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

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.

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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute

  collaborator OTHER

• James and Esther King Biomedical Research Program

  collaborator OTHER

• University of Miami

  lead OTHER

Principal Investigators

• David Lee, PhD · University of Miami

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2019-10-23

Completion

2019-10-23

FDA Drug

Yes

Countries

• United States

Study Locations