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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

March 11, 2009
February 27, 2014
April 2009
March 2013   (final data collection date for primary outcome measure)
  • 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
Prolonged smoking abstinence verified by breath carbon monoxide [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00861146 on ClinicalTrials.gov Archive Site
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.
Prolonged alcohol abstinence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Tobacco Use Cessation
  • Alcohol-related Disorders
Behavioral: behavioral counseling plus contingency management
Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
  • Experimental: 1 concurrent smoking cessation
    smoking cessation delivered concurrent with intensive alcohol treatment
    Intervention: Behavioral: behavioral counseling plus contingency management
  • Active Comparator: 2 deferred smoking cessation
    smoking cessation delivered 12 weeks after intensive alcohol treatment
    Intervention: Behavioral: behavioral counseling plus contingency management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00861146
NIAAA-Cooney-AA011197, R01AA011197, NIH Grant R01AA011197
No
Ned Cooney, Yale University
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Ned L Cooney, PhD Yale University
Yale University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP