NCT02151591

New Approaches to Smoking Cessation in Heavy Drinkers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Nicotine Dependence
• Cigarette Smoking
• Alcohol Consumption
• Heavy Drinking

Interventions

Type	Name	Description
DRUG	Varenicline	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

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-06-01
• Completion: 2018-08-01
• First posted: 2014-05-30
• Last updated: 2020-02-24
• Results posted: 2020-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study