Combined Treatment for Tobacco and Alcohol Use
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Smoking Cessation |
Behavioral: Questionnaires Behavioral: Motivational Relapse Prevention Counseling Behavioral: Relapse Plus Alcohol Risk Reduction Counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Combined Treatment for Tobacco and Alcohol Use |
- Overall At-risk Drinking Status [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
- Effectiveness of Certain Type of Telephone Counseling Ability to Help Participants Decrease Both Their Smoking and At-risk Alcohol Use. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | December 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Relapse Prevention Counseling |
Behavioral: Questionnaires
Participants will use a computer to complete a series of questionnaires.
Behavioral: Motivational Relapse Prevention Counseling
Total of 6 counseling calls: 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.
|
|
Active Comparator: Relapse Prevention + Alcohol Counseling
Motivational Relapse Prevention Plus Alcohol Risk Reduction Counseling
|
Behavioral: Questionnaires
Participants will use a computer to complete a series of questionnaires.
Behavioral: Relapse Plus Alcohol Risk Reduction Counseling
Total of 6 counseling calls: 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Texas | |
| U.T. M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | David Wetter, PHD, MS, BA | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | David Wetter, PHD, MS, BA /Professor, U.T. M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00592085 History of Changes |
| Other Study ID Numbers: | 2007-0111 |
| Study First Received: | December 27, 2007 |
| Results First Received: | September 8, 2009 |
| Last Updated: | October 7, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Tobacco Use Smoking Alcohol Use Smoking Cessation |
Additional relevant MeSH terms:
|
Alcohol Drinking Smoking Drinking Behavior Habits Ethanol Anti-Infective Agents, Local |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013