Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility Criteria

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 study

5. Pregnancy or lactation

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

7. Another household member enrolled in the study

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

David W. Wetter, PhD, MS

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00310141
Information obtained from ClinicalTrials.gov on November 20, 2012

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