search
Back to results

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Withdrawn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
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking Cessation focused on measuring Tobacco Use, Smoking, Alcohol Use, Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 27, 2007
    Last Updated
    July 18, 2016
    Sponsor
    M.D. Anderson Cancer Center
    search

    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

    We'll reach out to this number within 24 hrs