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New Approaches to Smoking Cessation in Heavy Drinkers

NCT02151591 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-02-24

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Lisa Fucito, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-06-01
Completion
2018-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02151591 on ClinicalTrials.gov