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A Pilot Clinical Trial of Varenicline as a Treatment for Alcohol Dependence

NCT01011907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2013-02-25

Study results available
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Summary

Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which either varenicline (twice daily) or placebo will be administered over a 12 week study period to examine genetic influences on treatment response to varenicline for reduction of hazardous drinking.

Conditions

  • Substance Dependence

Interventions

DRUG

varenicline

12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).

DRUG

placebo

12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

Sponsors & Collaborators

Principal Investigators

  • Howard Fields, MD PhD · UCSF: Ernest Gallo CLinic and Research Center

  • Jennifer Mitchell, PhD · UCSF: Ernest Gallo Clinic and Research Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-07-31
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT01011907 on ClinicalTrials.gov