Clinical Trial: Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

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 Summary:

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.
Sponsor: Yale University

Current Primary Outcome:

  • Smoking Abstinence [ Time Frame: 12 weeks ]
    7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
  • Smoking Abstinence [ Time Frame: 2 weeks ]
    7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking


Original Primary Outcome: Prolonged smoking abstinence verified by breath carbon monoxide [ Time Frame: 12 weeks ]

Current Secondary Outcome: Proportion of Days Heavy Drinking [ Time Frame: 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.


Original Secondary Outcome: Prolonged alcohol abstinence [ Time Frame: 12 weeks ]

Information By: Yale University

Dates:
Date Received: March 11, 2009
Date Started: April 2009
Date Completion:
Last Updated: February 27, 2014
Last Verified: February 2014