Culturally Specific Interventions: African American Smokers (SB2)

This study has been completed.
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Monica W. Hooper, University of Miami
ClinicalTrials.gov Identifier:
NCT01811758
First received: March 12, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Smoking
Smoking Cessation
Behavioral: Culturally Specific CBT
Behavioral: Standard CBT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Culturally Specific Interventions and Acculturation in African American Smokers

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 7-day point prevalence abstinence [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment: 345
Study Start Date: August 2011
Study Completion Date: April 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Culturally Specific CBT
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.
Behavioral: Culturally Specific CBT
Active Comparator: Standard CBT (control)
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.
Behavioral: Standard CBT

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01811758

Locations
United States, Florida
University of Miami
Coral Gables, Florida, United States, 33124
Sponsors and Collaborators
University of Miami
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Monica Hooper, PhD University of Miami
  More Information

No publications provided

Responsible Party: Monica W. Hooper, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01811758     History of Changes
Other Study ID Numbers: SmokeBreak2
Study First Received: March 12, 2013
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Culturally Specific Cognitive Behavioral Therapy
Standard Cognitive Behavioral Therapy

ClinicalTrials.gov processed this record on October 20, 2014