Combined Treatment for Tobacco and Alcohol Use
Primary Purpose
Smoking Cessation
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Questionnaires
Motivational Relapse Prevention Counseling
Relapse Plus Alcohol Risk Reduction Counseling
Sponsored by

About this trial
This is an interventional prevention trial for Smoking Cessation focused on measuring Tobacco Use, Smoking, Alcohol Use, Smoking Cessation
Eligibility Criteria
Inclusion Criteria:
- Current daily smoker who averages 5 or more cigarettes/day.
- 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:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Relapse Prevention Counseling
Relapse Prevention + Alcohol Counseling
Arm Description
Motivational Relapse Counseling: 6 counseling calls over two weeks accompanied by questionnaires
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
Outcomes
Primary Outcome Measures
Overall at-risk drinking status
At-risk drinking, defined by National Institute on Alcohol Abuse and Alcoholism, refers to a constellation of alcohol use behaviors that increase risk for physical and psychosocial problems including (a) an average of > 2 alcoholic beverages/day during the past 30 days for men or >1 drink/day for women, OR (b) two or more occasions of consuming > 5 alcoholic beverages during the past 30 days for men or >4 drinks for women, OR (c) driving after consuming >3 drinks in the past 30 days.
Secondary Outcome Measures
Effectiveness of certain type of telephone counseling ability to help participants decrease both their smoking and at-risk alcohol use as measured by Smoking Cessation and At-Risk Drinking Evaulation
Effectiveness evaluated using descriptive data from questionnaires to evaluate theoretically- and empirically-based "Motivational Relapse Prevention Plus Alcohol Risk Reduction" (MRP+) approach for simultaneously intervening on both smoking and at risk alcohol use. Evaluation through questionnaire results, smoking cessation and overall at-risk drinking status, a dichotomous variable defined previously.
Full Information
NCT ID
NCT00592085
First Posted
December 27, 2007
Last Updated
July 18, 2016
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00592085
Brief Title
Combined Treatment for Tobacco and Alcohol Use
Official Title
Combined Treatment for Tobacco and Alcohol Use
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Withdrawn
Why Stopped
No patients registered; study terminated.
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
Keywords
Tobacco Use, Smoking, Alcohol Use, Smoking Cessation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Relapse Prevention Counseling
Arm Type
Active Comparator
Arm Description
Motivational Relapse Counseling: 6 counseling calls over two weeks accompanied by questionnaires
Arm Title
Relapse Prevention + Alcohol Counseling
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Intervention Description
Participants will use a computer to complete a series of questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Relapse Prevention Counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relapse Plus Alcohol Risk Reduction Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall at-risk drinking status
Description
At-risk drinking, defined by National Institute on Alcohol Abuse and Alcoholism, refers to a constellation of alcohol use behaviors that increase risk for physical and psychosocial problems including (a) an average of > 2 alcoholic beverages/day during the past 30 days for men or >1 drink/day for women, OR (b) two or more occasions of consuming > 5 alcoholic beverages during the past 30 days for men or >4 drinks for women, OR (c) driving after consuming >3 drinks in the past 30 days.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Effectiveness of certain type of telephone counseling ability to help participants decrease both their smoking and at-risk alcohol use as measured by Smoking Cessation and At-Risk Drinking Evaulation
Description
Effectiveness evaluated using descriptive data from questionnaires to evaluate theoretically- and empirically-based "Motivational Relapse Prevention Plus Alcohol Risk Reduction" (MRP+) approach for simultaneously intervening on both smoking and at risk alcohol use. Evaluation through questionnaire results, smoking cessation and overall at-risk drinking status, a dichotomous variable defined previously.
Time Frame
Up to 3 months for baseline and repeat assessments at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Current daily smoker who averages 5 or more cigarettes/day.
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:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wetter, PHD, MS, BA
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center website
Learn more about this trial
Combined Treatment for Tobacco and Alcohol Use
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