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Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00861146
Recruitment Status : Completed
First Posted : March 13, 2009
Results First Posted : April 7, 2014
Last Update Posted : April 3, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Alcohol-related Disorders Behavioral: behavioral counseling plus contingency management Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
Study Start Date : April 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 concurrent smoking cessation
smoking cessation delivered concurrent with intensive alcohol treatment
 Behavioral: behavioral counseling plus contingency management
Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
Active Comparator: 2 deferred smoking cessation
smoking cessation delivered 12 weeks after intensive alcohol treatment
 Behavioral: behavioral counseling plus contingency management
Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum


Outcome Measures
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Primary Outcome Measures :
  1. Smoking Abstinence [ Time Frame: 12 weeks ]
    7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking

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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861146


Locations
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United States, Connecticut
VA Connecticut Healthcare System
Newington, Connecticut, United States, 06111
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Ned L Cooney, PhD Yale University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00861146    
Other Study ID Numbers: 0804003723
R01AA011197 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2009    Key Record Dates
Results First Posted: April 7, 2014
Last Update Posted: April 3, 2020
Last Verified: April 2020
Keywords provided by Yale University:
nicotine dependence
tobacco dependence
smoking cessation
 alcoholism
self-efficacy
relapse
Additional relevant MeSH terms:
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Recurrence
Alcohol-Related Disorders
Disease Attributes
Pathologic Processes
 Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders