CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Vareniclinedrug
Likely dose
Varenicline 0.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02151591
NCT02151591Phase 1Completed
CompareCT.gov

New Approaches to Smoking Cessation in Heavy Drinkers

Yale University·interventional·Posted May 30, 2014·Updated Feb 24, 2020

In Brief

A Phase 1 clinical trial evaluating Varenicline for Nicotine Dependence and 3 related conditions. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Dependence, Cigarette Smoking, Alcohol Consumption, Heavy Drinking
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 30, 2014
Enrollment StartMar 1, 2017
Primary CompletionJun 1, 2018
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.1 years ago

Interventions

Vareniclinedrug

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