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Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

NCT01342549 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2016-06-09

Study results available
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Summary

The purpose of this research study is to understand the effectiveness of valproate (a common mood stabilizer) to further reduce alcohol misuse when given in addition to attending an alcohol rehabilitation program as well as the treatment of mood disorders or PTSD. The main goal of this project is to understand if people receiving valproate will have a better recovery than people receiving the standard treatment for alcohol dependence: naltrexone.

Conditions

  • Alcohol Dependence

Interventions

DRUG

Valproate

250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60 mg per kg per day. Usual dosage is between 1250mg to 2000mg per day

DRUG

Naltrexone

25mg per day, taken by mouth for 7 days, then 50mg per day

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Ricardo E Jorge, MD · Michael E. DeBakey VA Medical Center, Houston, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-06-30
Completion
2015-06-30

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 NCT01342549 on ClinicalTrials.gov