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Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

NCT00006205 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2013-03-15

No results posted yet for this study

Summary

The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.

Conditions

  • Alcoholism

Interventions

DRUG

ondansetron + cognitive behavioral therapy

ondansetron (4 mcg/kg b.i.d)

DRUG

topiramate + cognitive behavioral therapy

topiramate (up to 300 mg/day)

DRUG

Placebo + cognitive behavioral therapy

placebo

DRUG

ondansetron + topiramate + cognitive behavioral therapy

ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Bankole Johnson

    lead OTHER

Principal Investigators

  • Bankole Johnson, DSc, MD, PhD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2013-06-30
Completion
2013-12-31

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 NCT00006205 on ClinicalTrials.gov