Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

University of Miami

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Behavioral: General Health Education; Behavioral: Group Cognitive Behavioral Therapy; Drug: Transdermal Nicotine Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02511236

20150356

Details and patient eligibility

About

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.

Enrollment: 356 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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356 participants in 2 patient groups

Group Cognitive Behavioral Therapy

Experimental group

Description:

Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].

Treatment:

Drug: Transdermal Nicotine Patch

Behavioral: Group Cognitive Behavioral Therapy

General Health Education

Active Comparator group

Description:

Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].

Treatment:

Drug: Transdermal Nicotine Patch

Behavioral: General Health Education