Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combined Treatment for Tobacco and Alcohol Use
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, October 2008
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00592085
  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: Motivational Relapse Prevention Plus Alcohol Risk Reduction Counseling

MedlinePlus related topics: Alcohol Consumption Quitting Smoking Smoking
Drug Information available for: Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Combined Treatment for Tobacco and Alcohol Use

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To examine the effectiveness of telephone counseling for smokers who also use alcohol. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Researchers want to learn if a certain type of telephone counseling might help participants decrease both their smoking and at-risk alcohol use. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2007
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Motivational Relapse Prevention Counseling
Behavioral: Questionnaires
Participants will use a computer to complete a series of questionnaires.
Behavioral: Motivational Relapse Prevention Counseling
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. These calls will take about 20 to 30 minutes each to complete.
2: Active Comparator
Motivational Relapse Prevention Plus Alcohol Risk Reduction Counseling
Behavioral: Questionnaires
Participants will use a computer to complete a series of questionnaires.
Behavioral: Motivational Relapse Prevention Plus Alcohol Risk Reduction Counseling
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. These calls will take about 20 to 30 minutes each 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592085

Contacts
Contact: David Wetter, PHD, MS, BA 713-745-2682

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: David Wetter, PHD, MS, BA            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: David Wetter, PHD, MS, BA U.T. M.D. Anderson Cancer Center
  More Information

MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

Responsible Party: U.T. M.D. Anderson Cancer Center ( David Wetter, PHD, MS, BA /Professor )
Study ID Numbers: 2007-0111
Study First Received: December 27, 2007
Last Updated: October 1, 2008
ClinicalTrials.gov Identifier: NCT00592085  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Tobacco Use
Smoking
Alcohol Use
Smoking Cessation

Study placed in the following topic categories:
Smoking
Drinking Behavior
Alcohol Drinking
Ethanol

Additional relevant MeSH terms:
Habits

ClinicalTrials.gov processed this record on January 16, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services