MedTrace Logo

Varenicline for Alcohol Dependence

NCT01146613 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-08-27

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as "very heavy" drinkers).

Conditions

  • Alcoholism

Interventions

DRUG

Varenicline

0.5mg capsules x 2, 2x a day for 12 weeks

DRUG

Placebo

identical matched placebo x 2, 2xday, 13 weeks

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Raye Z. Litten, PhD · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  • Joanne Fertig, PhD · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  • Daniel E Falk, PhD · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-06-30
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01146613 on ClinicalTrials.gov