Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2007-12-31
2008-11-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Relapse Prevention Counseling
Motivational Relapse Counseling: 6 counseling calls over two weeks accompanied by questionnaires
Questionnaires
Participants will use a computer to complete a series of questionnaires.
Motivational Relapse Prevention Counseling
Total of 6 counseling calls for Smoking Relapse: First counseling call will be to set up your quit date; then 5 additional counseling calls within 12 weeks after enrollment, each 20 to 30 minutes to complete.
Relapse Prevention + Alcohol Counseling
Motivational Relapse Prevention Plus Alcohol Risk Reduction Counseling: 6 counseling calls over two weeks for both smoking cessation and at-risk alcohol use accompanied by questionnaires
Questionnaires
Participants will use a computer to complete a series of questionnaires.
Relapse Plus Alcohol Risk Reduction Counseling
Total of 6 counseling calls for both Smoking Relapse and Alcohol Risk: First counseling call will be to set up your quit date; then 5 additional counseling calls within 12 weeks after enrollment, each 20 to 30 minutes to complete.
Interventions
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Questionnaires
Participants will use a computer to complete a series of questionnaires.
Motivational Relapse Prevention Counseling
Total of 6 counseling calls for Smoking Relapse: First counseling call will be to set up your quit date; then 5 additional counseling calls within 12 weeks after enrollment, each 20 to 30 minutes to complete.
Relapse Plus Alcohol Risk Reduction Counseling
Total of 6 counseling calls for both Smoking Relapse and Alcohol Risk: First counseling call will be to set up your quit date; then 5 additional counseling calls within 12 weeks after enrollment, each 20 to 30 minutes to complete.
Eligibility Criteria
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Inclusion Criteria
* Exhibit at least one of the following criteria for at-risk drinking: a) an average of \> or equal to 2 alcoholic beverages/day during the past 30 days for men or \> or equal to 1 drink/day for women, OR b) two or more occasions of consuming \> or equal to 5 alcoholic beverages during the past 30 days for men or \> or equal to 4 drinks for women, OR c) driving after consuming \> or equal to 3 drinks in the past 30 days,
* Age 18 or above
* Motivated to quit smoking in the next 30 days
* Viable (working) telephone number and home address
* No other household member enrolled in this protocol
* Score equal to or less than 15 on the Alcohol Use Disorders Identification Test (AUDIT) measure.
* Must be able to speak English.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Wetter, PHD, MS, BA
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Related Links
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MD Anderson Cancer Center website
Other Identifiers
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2007-0111
Identifier Type: -
Identifier Source: org_study_id
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