Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
Primary Purpose
Tobacco Use Cessation, Alcohol-related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
behavioral counseling plus contingency management
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Cessation focused on measuring nicotine dependence, tobacco dependence, smoking cessation, alcoholism, self-efficacy, relapse
Eligibility 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
Sites / Locations
- VA Connecticut Healthcare System
- VA Connecticut Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1 concurrent smoking cessation
2 deferred smoking cessation
Arm Description
smoking cessation delivered concurrent with intensive alcohol treatment
smoking cessation delivered 12 weeks after intensive alcohol treatment
Outcomes
Primary Outcome Measures
Smoking Abstinence
7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Smoking Abstinence
7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Secondary Outcome Measures
Proportion of Days Heavy Drinking
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.
Full Information
NCT ID
NCT00861146
First Posted
March 11, 2009
Last Updated
April 1, 2020
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00861146
Brief Title
Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
Official Title
Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Cessation, Alcohol-related Disorders
Keywords
nicotine dependence, tobacco dependence, smoking cessation, alcoholism, self-efficacy, relapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 concurrent smoking cessation
Arm Type
Experimental
Arm Description
smoking cessation delivered concurrent with intensive alcohol treatment
Arm Title
2 deferred smoking cessation
Arm Type
Active Comparator
Arm Description
smoking cessation delivered 12 weeks after intensive alcohol treatment
Intervention Type
Behavioral
Intervention Name(s)
behavioral counseling plus contingency management
Intervention Description
Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
Primary Outcome Measure Information:
Title
Smoking Abstinence
Description
7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Time Frame
12 weeks
Title
Smoking Abstinence
Description
7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Proportion of Days Heavy Drinking
Description
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.
Time Frame
follow-up weeks 9-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ned L Cooney, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
Newington
State/Province
Connecticut
ZIP/Postal Code
06111
Country
United States
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25622198
Citation
Cooney NL, Litt MD, Sevarino KA, Levy L, Kranitz LS, Sackler H, Cooney JL. Concurrent alcohol and tobacco treatment: Effect on daily process measures of alcohol relapse risk. J Consult Clin Psychol. 2015 Apr;83(2):346-58. doi: 10.1037/a0038633. Epub 2015 Jan 26.
Results Reference
derived
Learn more about this trial
Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
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