Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

Phase 2

Completed

• Conditions: Tobacco Use Cessation; Alcohol-related Disorders
• Interventions: Behavioral: behavioral counseling plus contingency management

• Registration Number: NCT00861146
• Lead Sponsor: Yale University

Brief Summary

The majority of individuals with alcohol problems remain current smokers, and the negative health consequences of smoking among these individuals are substantial. This study will investigate the impact of smoking cessation interventions initiated during intensive alcohol treatment on processes reflecting risk of alcohol relapse.

Detailed Description

Objectives:

Most alcohol and drug treatment programs do not systematically address cigarette smoking during treatment. One obstacle is a concern that smoking cessation early in recovery might increase risk of alcohol relapse. This study followed patients enrolled in intensive outpatient alcohol treatment to compare the effects of a Concurrent Smoking Cessation (CSC) intervention to a Deferred Smoking Cessation (DSC) control group on process measures reflecting risk of alcohol relapse.

Research Design:

Participants were enrolled in intensive outpatient alcohol treatment and then randomized to CSC or DSC groups in a 2:1 ratio. The CSC group received smoking treatment concurrent with intensive alcohol treatment and the DSC group received smoking treatment three months after alcohol treatment. The smoking treatment protocol included behavioral counseling, contingency management with voucher rewards for verified smoking abstinence, and prescribed nicotine patch and gum. During a three-month period after the CSC target smoking quit date, both groups of subjects were asked to participate in a prospective daily monitoring procedure, calling into an Interactive Voice Response system once a day to complete self-report assessments of relapse risk factors. By comparing participants in the CSC group composed of many participants who have stopped smoking with the DSC group who are expected to continue smoking during this daily monitoring period, we will determine the impact of smoking cessation on alcohol relapse risk factors.

Methodology:

This study was conducted in the substance abuse day treatment programs located at Newington and West Haven campuses of VA Connecticut Healthcare System. These are three-week treatment programs meeting Monday-Friday for 4-5 hrs/day. Participants were recruited either before or soon after day program admission. Participants 151 individuals that are 18 years of age or older, meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol abuse or dependence, report currently smoking 1 or more cigarettes per day, and are screened for medical contraindications for nicotine patch and gum use. Dependent variables are process assessments reflecting alcohol relapse risk obtained using daily Interactive Voice Response (IVR) technology. These relapse risk processes include alcohol craving, negative affect, alcohol abstinence self efficacy, alcohol outcome expectancies, motivation for alcohol abstinence, and self-control demands. Given the mixed results from previous clinical trials, we conducted bidirectional tests of the hypothesis that smoking cessation has an impact on alcohol relapse risk factors, examining whether smoking cessation leads to increased or decreased alcohol relapse risk.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Study Start: 2009-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2014-01-15
• Results First Submitted QC: 2014-02-27
• Results First Posted: 2014-04-07
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• DSM-IV criteria for alcohol abuse or dependence
• Age 18 or older
• English speaking
• Smoking 1 or more cigarettes/day
• Male or female veterans eligible for VA healthcare
• Female nonveterans also eligible

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Exclusion Criteria

• Allergy or hypersensitivity to nicotine or adhesives used in nicotine patch
• Weigh less than 100 lbs
• Lack of interest in stopping smoking
• Pregnant or lactating females or females not practicing acceptable form of contraception

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 deferred smoking cessation	behavioral counseling plus contingency management	smoking cessation delivered 12 weeks after intensive alcohol treatment
1 concurrent smoking cessation	behavioral counseling plus contingency management	smoking cessation delivered concurrent with intensive alcohol treatment

Primary Outcome Measures

Name	Time	Method
Smoking Abstinence	2 weeks	7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking

Secondary Outcome Measures

Name	Time	Method
Proportion of Days Heavy Drinking	follow-up weeks 9-12	Heavy drinking days were defined as days with \> 6 standard drinks per day for men and \> 4 standard drinks per day for women. This measure examined the proportion of days heavy drinking across 28 days in follow-up weeks 9-12.

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States