CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
varenicline +1 moredrug
Likely dose
varenicline 2mgfrom 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/NCT00580645
NCT00580645Phase 2Completed
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Do Treatments for Smoking Cessation Affect Alcohol Drinking?

Yale University·interventional·Posted Dec 27, 2007·Updated Feb 7, 2018

In Brief

A Phase 2 clinical trial evaluating varenicline and placebo for Alcohol Drinking. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated. Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior. Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Drinking
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 27, 2007
Enrollment StartApr 1, 2007
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 18.5 years ago

Interventions

vareniclinedrug

2mg/day or 1mg/day with 1-week medication lead-in period.

placebodrug

placebo