Culturally Specific Interventions: African American Smokers (SB2)

University of Miami

Status and phase: Completed; Phase 2; Phase 1

Conditions: Smoking; Smoking Cessation

Treatments: Behavioral: Culturally Specific CBT; Behavioral: Standard CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT01811758

SmokeBreak2

Details and patient eligibility

About

The investigators expect that a culturally specific group intervention targeting African American smokers will result in greater smoking cessation rates compared to a standard intervention.

Enrollment: 345 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. self-identification as African American
2. current smoker of ≥ 5 cigarettes/day or expired CO level of ≥ 8 ppm;
3. age 18-65;
4. able to speak and read English;
5. permanent contact information;
6. access to transportation by public transit or car;
7. no current behavioral or pharmacological treatment ;
8. interest in quitting smoking; (9) have availability to attend sessions.

Exclusion criteria

1. enrolled in another cessation program,
2. do not speak and read English,
3. do not have access to transportation by car or bus to attend sessions,
4. do not have childcare during session times,
5. have contraindications for patch use (pregnant/breastfeeding),
6. if they are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse),
7. if they endorse active addiction to another substance (e.g., illicit drugs or alcohol),
8. if they have been diagnosed with an acute cardiac or respiratory condition;
9. people identified as having a severe mental illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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345 participants in 2 patient groups

Culturally Specific CBT

Experimental group

Description:

Culturally specific cognitive behavioral therapy. Group format, 8 sessions, approximately 90 minutes. Up to 8-weeks of transdermal nicotine patches. Focused on African Americans: smoking patterns, health outcomes, discrimination, stress, weight concerns, cultural beliefs and practices.

Treatment:

Behavioral: Culturally Specific CBT

Standard CBT (control)

Active Comparator group

Description:

Standard cognitive behavioral therapy. Group format, 8 sessions, approximately 90 minutes each. Up to 8-weeks of transdermal nicotine patches. Traditional CBT, with no focus on race: smoking and health, benefits of quitting, weight control, relapse prevention, coping skills.

Treatment:

Behavioral: Standard CBT