Culturally Specific Interventions: African American Smokers

Smoking Cessation Clinical Trial

— SB2  

Official title:

Culturally Specific Interventions and Acculturation in African American Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811758
• Other study ID #: SmokeBreak2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 12, 2013
• Last updated: July 9, 2015
• Start date: August 2011
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: April 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

Behavioral:
• Culturally Specific CBT

• Standard CBT

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hooper MW, Larry R, Okuyemi K, Resnicow K, Dietz NA, Robinson RG, Antoni MH. Culturally specific versus standard group cognitive behavioral therapy for smoking cessation among African Americans: an RCT protocol. BMC Psychol. 2013 Aug 21;1(1):15. doi: 10.1186/2050-7283-1-15. eCollection 2013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence abstinence	Generalized linear mixed model of overall intervention effect.	Overall effect at 12-months	No
Secondary	7-day point prevalence abstinence		6-months	No