Combined Treatment for Tobacco and Alcohol Use

Smoking Cessation Clinical Trial

Official title: Combined Treatment for Tobacco and Alcohol Use

Status Withdrawn

Clinical Trial Summary

The specific aims are to:

• Develop a "Motivational Relapse Prevention Plus Alcohol Risk Reduction" (MRP+) approach to simultaneously treating both smoking and "at-risk" alcohol use among smokers attempting to quit smoking.

• Estimate the effect size for MRP+ relative to Motivational Relapse Prevention without a focus on alcohol (MRP) with respect to alcohol at-risk behaviors. The estimated effect size will be utilized to help guide sample size estimates for a potential clinical trial.

Clinical Trial Description

Study Participation If you agree to take part in this study, you will come to M. D. Anderson and use a computer to complete a series of questionnaires. You will be asked questions about your living situation, mood, depression, anxiety, appetite, smoking and alcohol use habits, social status, finances, job, physical activity, and support from family and/or friends. These questionnaires may take a total of about 1 hour to complete.

After completing the questionnaires, you will be randomly assigned (as in the toss of a coin) to one of two groups. One group will receive counseling (called motivational relapse prevention counseling), which will focus on smoking cessation. The other group will also receive counseling (called motivational relapse prevention plus alcohol risk reduction counseling), which will focus on smoking cessation as well but will also include discussion about at-risk alcohol use. Both groups will receive reading materials related to smoking cessation. The motivational relapse prevention plus alcohol risk reduction group will also receive reading materials related to alcohol use.

You will receive a total of 6 counseling calls during this study. Your first counseling call will be to set up your quit date. You will then have 5 additional counseling calls within the 12 weeks after your enrollment in the study. The timing of these calls will be determined between you and your counselor. Depending on which group you are in, you will be counseled on strategies for quitting smoking and/or decreasing alcohol use to help decrease your risk of cancer. These calls will take about 20 to 30 minutes each to complete. You will be asked to provide contact information for friends and/or relatives. The research staff will contact them only if you are unable to be contacted after multiple attempts.

Final Visit At Week 12, you will be requested to return to M. D. Anderson to complete the last computerized series of questionnaires.

Your counseling calls will be tape recorded so researchers can make sure that correct procedures are being followed. Only the study staff will be allowed to listen to these tapes. Your identity will be kept secure and confidential. These tapes will be erased when this study has ended.

Study Length Your participation in this study will be over after the evaluation visit at Week 12. ;

Study Design

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Smoking Cessation

• NCT number: NCT00592085
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: N/A
• Start date: December 2007
• Completion date: November 2008