Combined Treatment for Tobacco and Alcohol Use
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Overall At-risk Drinking Status
Baseline and Week 12
David Wetter, PHD, MS, BA
M.D. Anderson Cancer Center
United States: Institutional Review Board
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