Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

1. 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 will follow 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.

2. Research Design:

Participants will be enrolled in intensive outpatient alcohol treatment and then
randomized to CSC or DSC groups in a 2:1 ratio. The CSC group will receive smoking
treatment concurrent with intensive alcohol treatment and the DSC group will receive
smoking treatment three months after alcohol treatment. The smoking treatment protocol
will include 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 will
be 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.

3. Methodology:

This study will be 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 may be recruited
either before or soon after day program admission. Participants will be 144 individuals that
are 18 years of age or older, meet DSM-IV diagnostic criteria for current alcohol abuse or
dependence, report currently smoking 10 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 will conduct 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.

Inclusion Criteria:

- DSM-IV criteria for alcohol abuse or dependence

- Age 18 or older

- English speaking

- Smoking 10 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