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Culturally Specific Interventions: African American Smokers (SB2)

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ClinicalTrials.gov Identifier: NCT01811758
Recruitment Status : Completed
First Posted : March 15, 2013
Last Update Posted : July 10, 2015
Sponsor:
Collaborator:
University of Minnesota
Information provided by (Responsible Party):
Monica W. Hooper, University of Miami

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Smoking Cessation Behavioral: Culturally Specific CBT Behavioral: Standard CBT Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Culturally Specific Interventions and Acculturation in African American Smokers
Study Start Date : August 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 7-day point prevalence abstinence [ Time Frame: Overall effect at 12-months ]
    Generalized linear mixed model of overall intervention effect.


Secondary Outcome Measures :
  1. 7-day point prevalence abstinence [ Time Frame: 6-months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811758


Locations
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United States, Florida
University of Miami
Coral Gables, Florida, United States, 33124
Sponsors and Collaborators
University of Miami
University of Minnesota
Investigators
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Principal Investigator: Monica Hooper, PhD University of Miami

Publications:
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Responsible Party: Monica W. Hooper, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01811758     History of Changes
Other Study ID Numbers: SmokeBreak2
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: July 10, 2015
Last Verified: July 2015
Keywords provided by Monica W. Hooper, University of Miami:
Culturally Specific Cognitive Behavioral Therapy
Standard Cognitive Behavioral Therapy