Combined Treatment for Tobacco and Alcohol Use

Smoking Cessation Clinical Trial

Official title:

Combined Treatment for Tobacco and Alcohol Use

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00592085
• Other study ID #: 2007-0111
• Status: Withdrawn
• Phase: N/A
• First received: December 27, 2007
• Last updated: July 18, 2016
• Start date: December 2007
• Est. completion date: November 2008

Study information

• Verified date: September 2009
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Drinking
• Smoking Cessation

Intervention

Behavioral:
• Questionnaires
Participants will use a computer to complete a series of questionnaires.
• Motivational Relapse Prevention Counseling
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 Plus Alcohol Risk Reduction Counseling
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Up to 3 months for baseline and repeat assessments at 12 weeks	No

External Links

•   MD Anderson Cancer Center website