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Treatment of Nicotine Dependence Among African Americans

21 Years
65 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Treatment of Nicotine Dependence Among African Americans


- 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.

Inclusion Criteria:

1. African American

2. Age 21 to 65 years

3. Current Smoker (history of at least 5 cigarettes/day for the last year)

4. Motivated to quit within the next 14 days

5. Participants must provide a viable home address and functioning home telephone number

6. Can speak, read, write in English at a sixth-grade literacy level

7. Provide viable collateral contact information

8. Register "8" or more on a carbon monoxide breath test

Exclusion Criteria:

1. Contraindication for nicotine patch use

2. Active substance dependence (exclusive of nicotine dependence)

3. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless)

4. Use of bupropion or nicotine products other than nicotine patches supplied by the

5. Pregnancy or lactation

6. Any active illness that precludes full participation in the study protocol

7. Another household member enrolled in the study

Type of Study:


Study Design:

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

Outcome Measure:

Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment

Outcome Time Frame:

6 months after treatment

Safety Issue:


Principal Investigator

David W. Wetter, PhD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2002

Completion Date:

Related Keywords:

  • Lung Cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • Lung Neoplasms
  • Tobacco Use Disorder



M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030