Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ned Cooney, Yale University
ClinicalTrials.gov Identifier:
NCT00861146
First received: March 11, 2009
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Tobacco Use Cessation
Alcohol-related Disorders
Behavioral: behavioral counseling plus contingency management
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Smoking Abstinence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking

  • Smoking Abstinence [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking


Secondary Outcome Measures:
  • Proportion of Days Heavy Drinking [ Time Frame: follow-up weeks 9-12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 151
Study Start Date: April 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861146

Locations
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
Investigators
Principal Investigator: Ned L Cooney, PhD Yale University
  More Information

No publications provided

Responsible Party: Ned Cooney, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00861146     History of Changes
Other Study ID Numbers: NIAAA-Cooney-AA011197, R01AA011197, NIH Grant R01AA011197
Study First Received: March 11, 2009
Results First Received: January 15, 2014
Last Updated: February 27, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
nicotine dependence
tobacco dependence
smoking cessation
alcoholism
self-efficacy
relapse

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Alcohol-Related Disorders
Habits
Substance-Related Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 20, 2014