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Treatment of Nicotine Dependence Among African Americans
RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and computer-assisted counseling may help people stop smoking. PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling helps African American smokers stop smoking.
OBJECTIVES: * Develop and evaluate the efficacy of an interactive, culturally sensitive, individualized, palmtop computer-delivered smoking cessation intervention for African American smokers. * Examine how hypothesized treatment mechanisms mediate the effects of computer-delivered treatment on abstinence. OUTLINE: This is a randomized study. A subset of 20 participants are assigned to arm II for pilot testing. All other participants are randomized to 1 of 2 intervention arms. * Arm I (standard care \[SC\]): Participants receive nicotine patch therapy on days -5 to 31. Participants also receive a Pathways to Freedom self-help guide and undergo 5 in-person counseling sessions based on the Treating Tobacco Use and Dependence Clinical Practice Guideline. The counseling sessions occur at 12 and 5 days prior to the quit smoking date and at 3, 10, and 31 days after the quit smoking date. * Arm II (computer-delivered treatment \[CDT\]): Participants receive the same intervention as in arm I. Participants also undergo CDT for 6 weeks comprising 5 modules (quitting strategies; motivation and support; general smoking information; calendars and fun stuff; and daily tips) beginning 12 days prior to the quit smoking date and continuing for 31 days after the quit smoking date. All participants complete questionnaires at baseline, during the counseling sessions, and then at approximately 6 months after the quit smoking date. After completion of study intervention, participants are followed at approximately 6 months. PROJECTED ACCRUAL: A total of 500 participants will be accrued for this study.
Age
21 - 65 years
Sex
ALL
Healthy Volunteers
No
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Start Date
April 8, 2002
Primary Completion Date
August 17, 2006
Completion Date
August 30, 2016
Last Updated
August 22, 2017
462
ACTUAL participants
Smoking cessation intervention
BEHAVIORAL
Counseling intervention
OTHER
Nicotine patch
DRUG
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT06305754
NCT06498635
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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