CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
Valproate +1 moredrug
Likely dose
Valproate 250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01342549
NCT01342549Phase 3Completed
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Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

VA Office of Research and Development·interventional·Posted Apr 27, 2011·Updated Jun 9, 2016

In Brief

A Phase 3 clinical trial evaluating Valproate and Naltrexone for Alcohol Dependence. Completed, enrolled 62 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 27, 2011
Enrollment StartSep 1, 2011
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.2 years ago

Interventions

Valproatedrug

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

Naltrexonedrug

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