Combined Treatment for Tobacco and Alcohol Use

NCT00592085 | Withdrawn DMC

• 1 other identifier: 2007-0111
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Smoking Cessation

Keywords

Tobacco Use; Smoking; Alcohol Use; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12

Secondary Outcomes (1)

• 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

  Up to 3 months for baseline and repeat assessments at 12 weeks

Study Arms (2)

Relapse Prevention Counseling

ACTIVE COMPARATOR

Motivational Relapse Counseling: 6 counseling calls over two weeks accompanied by questionnaires

Behavioral: Questionnaires; Behavioral: Motivational Relapse Prevention Counseling

Relapse Prevention + Alcohol Counseling

ACTIVE COMPARATOR

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

Behavioral: Questionnaires; Behavioral: Relapse Plus Alcohol Risk Reduction Counseling

Interventions

Questionnaires BEHAVIORAL

Participants will use a computer to complete a series of questionnaires.

Relapse Prevention + Alcohol Counseling; Relapse Prevention Counseling

Motivational Relapse Prevention Counseling BEHAVIORAL

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.

Relapse Prevention Counseling

Relapse Plus Alcohol Risk Reduction Counseling BEHAVIORAL

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.

Relapse Prevention + Alcohol Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Related Links

• MD Anderson Cancer Center website

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use; Smoking; Alcohol Drinking

Interventions

Surveys and Questionnaires; Ethanol

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Drinking Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Alcohols; Organic Chemicals

Study Officials

• David Wetter, PHD, MS, BA

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 11, 2008
• Study Start: December 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 20, 2016

Record last verified: 2009-09