Combined Treatment for Tobacco and Alcohol Use

This study has been terminated.
(No patients registered; study terminated.)
Sponsor:
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00592085
First received: December 27, 2007
Last updated: October 7, 2009
Last verified: September 2009
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall At-risk Drinking Status [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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 April 17, 2014