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Combined Pharmacotherapies for Alcoholism

NCT00768508 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-03-15

No results posted yet for this study

Summary

This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence.

Conditions

  • Alcoholism

Interventions

DRUG

Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy

Ondansetron 4 ug/kg b.i.d.for 12 weeks

DRUG

Naltrexone 50 mg/day + Cognitive Behavioral Therapy

Naltrexone 50 mg/day for 12 weeks

DRUG

Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy

Combination of ondansetron 4 ug/kg b.i.d. and naltrexone 50 mg/day for 12 weeks

OTHER

Placebo + Cognitive Behavioral Therapy

Placebo comparator

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
2008-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

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 NCT00768508 on ClinicalTrials.gov