Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

Tobacco Use Cessation Clinical Trial

Official title:

Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861146
• Other study ID #: 0804003723
• Secondary ID: R01AA011197
• Status: Completed
• Phase: Phase 2
• Start date: April 2009
• Est. completion date: March 2013

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Alcohol-related Disorders
• Recurrence
• Tobacco Use Cessation

Intervention

Behavioral:
• behavioral counseling plus contingency management
Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	Newington	Connecticut
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Abstinence	7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking	12 weeks
Primary	Smoking Abstinence	7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking	2 weeks
Secondary	Proportion of Days Heavy Drinking	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.	follow-up weeks 9-12