The purpose of this study is to develop and test an integrated cognitive-behavioral intervention for smoking and alcohol among heavy drinking smokers. The current pre-pilot phase will be used to refine this protocol for the subsequent randomized, controlled pilot phase. The current study phase has two parts: 1) an intake session and brief physical; 2) a 12-week treatment phase in which participants receive varenicline (Chantix) and weekly, personalized counseling.
The purpose of the proposed project is to develop and test a 12-week integrated cognitive-behavioral therapy (CBT) intervention for smoking and alcohol (SA) + varenicline (Chantix) among heavy drinking smokers (i.e., CBT for SA). The project involves two phases. In Phase 1, an open-label pre-pilot study of CBT for SA will be conducted with 10 heavy drinking smokers. The primary results of this phase will be used to refine the CBT for SA protocol. In Phase 2, a randomized, controlled pilot study will be conducted with 40 heavy drinking smokers comparing CBT for SA with standard smoking counseling (SC). All participants in the randomized pilot study will also receive varenicline (Chantix). Primary and Study Completion dates were changed 6/2016 to reflect an additional year added year to the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day
Yale University School of Medicine
New Haven, Connecticut, United States
Number of Participants With Smoking Abstinence at 6 Months
Number of participants with point prevalence smoking abstinence (i.e., no smoking, not even a puff over the last 7 days) 6 months after treatment completion.
Time frame: 6 months post treatment start
Log Transformed Percentage of Heavy Drinking Days
Log transformed percentage of heavy drinking days 6 months post treatment start.
Time frame: 6 months post treatment start
Number of Participants Who Completed Treatment.
To assess feasibility/acceptability, the number of participants who completed treatment will be assessed.
Time frame: 12 weeks
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