Clinical trial NCT00861146: Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
Official title: Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Cessation
Alcohol-related Disorders
Keywords: nicotine dependence
tobacco dependence
smoking cessation
alcoholism
self-efficacy
relapse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2009-03-13
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Abstinence
timeFrame: 12 weeks
measure: Smoking Abstinence
timeFrame: 2 weeks
Secondary outcomes:
measure: Proportion of Days Heavy Drinking
timeFrame: follow-up weeks 9-12
Other outcomes:
Locations:
city: Newington
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Ned L Cooney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cooney NL, Litt MD, Sevarino KA, Levy L, Kranitz LS, Sackler H, Cooney JL. Concurrent alcohol and tobacco treatment: Effect on daily process measures of alcohol relapse risk. J Consult Clin Psychol. 2015 Apr;83(2):346-58. doi: 10.1037/a0038633. Epub 2015 Jan 26.