Phase 2
N=151
Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
Tobacco Use Cessation · Alcohol-related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00861146 ↗Enrolled (actual)
151
Serious AEs
4.0%
Results posted
Apr 2014
Primary outcome: Primary: Smoking Abstinence — 20; 1 participants — p=<.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- behavioral counseling plus contingency management (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Abstinence |
53; 1 | <.001 sig |
| PRIMARY Smoking Abstinence |
53; 1 | <.001 sig |
| SECONDARY Proportion of Days Heavy Drinking |
.0332; .0132 | > .15 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00861146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.