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Optimizing Pharmacotherapy for Bipolar Alcoholics

NCT00302133 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2016-05-17

Study results available
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Summary

The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.

Conditions

Interventions

DRUG

Naltrexone hydrochloride

Naltrexone hydrochloride 50 mg capsule daily for 12 weeks

OTHER

Placebo

Placebo arm

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Ihsan M Salloum, MD, MPH · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2013-04-30
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00302133 on ClinicalTrials.gov