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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00187603
Other study ID # 12AT-1700
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated May 5, 2008
Start date July 2003
Est. completion date June 2007

Study information

Verified date August 2005
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Among all racial/ethnic groups, African Americans have the greatest risk of becoming ill or dying from tobacco-related diseases. Because of this disproportionate disease burden, it is particularly urgent that researchers focusing on tobacco control partner with African American communities. Intervention strategies which hold the tobacco industry accountable for its behavior are effective in changing views of tobacco use. In earlier work, the investigators found that information from internal tobacco industry documents, when shown to African American smokers, stimulated reflection about quitting and interest in disseminating information about industry targeting behaviors to others. However, to date there have been no attempts to utilize the information in industry documents as part of a smoking cessation intervention. In this project, the investigators will test whether a community co-developed, tailored quit-smoking program featuring exposures to African American-specific tobacco industry documents and media exercises in addition to proven individual quitting strategies can increase the number of people who quit smoking at six months and one year, as compared with usual care.

The specific aims of the project are to:

1. test, using statistics, how well an innovative community-based, culturally tailored quit-smoking program for African Americans works at 6 and 12 months;

2. test selected variables for how well they predict who will return to smoking;

3. use interviews to identify additional individual and/or community factors associated with successful quitting or relapse; and

4. collect information to evaluate the overall effectiveness of the CARA project collaborative efforts in developing and sustaining the project over time, enhancing community awareness of tobacco issues, and creation or enhancement of community tobacco control resources.


Description:

Among all racial/ethnic groups, African Americans have the greatest risk of becoming ill or dying from tobacco-related diseases. Because of this disproportionate disease burden, it is particularly urgent that researchers focusing on tobacco control partner with African American communities. Intervention strategies which hold the tobacco industry accountable for its behavior are effective in changing views of tobacco use. In earlier work, we found that information from internal tobacco industry documents, when shown to African American smokers, stimulated reflection about quitting and interest in disseminating information about industry targeting behaviors to others. However, to date there have been no attempts to utilize the information in industry documents as part of a smoking cessation intervention. In this project, we will test whether a community co-developed, tailored quit-smoking program featuring exposures to African American-specific tobacco industry documents and media exercises in addition to proven individual quitting strategies can increase the number of people who quit smoking at six months and one year, as compared with usual care.

The specific aims of the project are to:

1. test, using statistics, how well an innovative community-based, culturally tailored quit-smoking program for African Americans works at 6 and 12 months;

2. test selected variables for how well they predict who will return to smoking;

3. use interviews to identify additional individual and/or community factors associated with successful quitting or relapse; and

4. collect information to evaluate the overall effectiveness of the CARA project collaborative efforts in developing and sustaining the project over time, enhancing community awareness of tobacco issues, and creation or enhancement of community tobacco control resources.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date June 2007
Est. primary completion date February 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- African American adults who have used tobacco in the last month

Exclusion Criteria:

- Unable to read or speak English

- Dependence on other substances (except for marijuana)

- Disabling health conditions that would prevent participation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
tobacco cessation program


Locations

Country Name City State
United States University of California San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco Tobacco Related Disease Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking cessation (cotinine validation) at 6 and 12 months
Secondary Qualitative interviews
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