Trial Information

Treatment of Nicotine Dependence Among African Americans

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.