Culturally Specific Interventions: African American Smokers (SB2)

July 9, 2015 updated by: Monica W. Hooper, University of Miami

Culturally Specific Interventions and Acculturation in African American Smokers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

345

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33124
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day point prevalence abstinence
Time Frame: Overall effect at 12-months
Generalized linear mixed model of overall intervention effect.
Overall effect at 12-months

Secondary Outcome Measures

Outcome Measure
Time Frame
7-day point prevalence abstinence
Time Frame: 6-months
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

University of Minnesota

Investigators

  • Principal Investigator: Monica Hooper, PhD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 15, 2013

Study Record Updates

Last Update Posted (Estimate)

July 10, 2015

Last Update Submitted That Met QC Criteria

July 9, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SmokeBreak2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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