Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

Phase 3

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: Valproate; Drug: Naltrexone

• Registration Number: NCT01342549
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed Description

Veterans are vulnerable to develop complex forms of addictive disorders characterized by the presence of traumatic brain injury and psychiatric conditions such as post-traumatic stress disorder and mood disturbances. Alcohol use disorders are frequently observed among veterans and exert a detrimental effect on community reintegration after deployment. Attending to this veteran health problem, the VA is devoting extraordinary efforts to develop adequate treatment strategies. In this study we will evaluate treatment outcomes and identify specific factors that influence alcohol use disorders treatment response in a VA Intensive Outpatient Program offering rehabilitation treatment to the growing number of veterans with alcohol use disorders. Cooperation between researchers and clinical staff will allow optimizing treatment strategies that enhance the recovery of veterans with alcohol use disorders.

Study Timeline

• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-04-26
• Study First Posted: 2011-04-27
• Study Start: 2011-09
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-05
• Results First Submitted: 2016-05-02
• Results First Submitted QC: 2016-05-02
• Last Update Submitted: 2016-05-02
• Results First Posted: 2016-06-09
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62

Inclusion Criteria

• Veterans attending alcohol use disorders rehabilitation treatment within the VA
• Presence of a diagnosis of alcohol dependence according to DSM-IV
• A history of heavy drinking
• Absence of withdrawal symptoms

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Exclusion Criteria

• Evidence of other substance abuse different from nicotine or cannabis (DSM-IV criteria) or by 2 consecutive positive urine drug screens
• Unstable medical conditions such as severe heart disease, liver or renal failure or evidence of neoplasia.
• Liver Enzymes (ALT, AST) serum levels >3 times the upper limit of normal
• Unstable psychiatric conditions that requires treatment in a more structured setting (i.e. active SI, worsening psychotic symptoms or acute mania)
• Diagnosis of schizophrenia or schizoaffective disorder
• Requiring therapy with valproate or naltrexone or has a history of significant side effects from either study drug
• Requiring therapy with topiramate, lamotrigine or carbamazepine
• Requiring chronic treatment with opioid analgesics for refractory pain
• Failed 3 previous intensive alcohol rehabilitation programs in the past 2 years
• Females

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Valproate	sodium valproate
Arm 2	Naltrexone	naltrexone

Primary Outcome Measures

Name	Time	Method
Time to Relapse to Heavy Drinking as Defined by Having 5 or More Drinks in a Sitting for Men and Will be Assessed Using the Time Line Follow Back for Recent Drinking Method. A Structured Questionnaire Will Review Alcohol Consumed on the Previous Week.	24 weeks

Trial Locations

Locations (2)

Iowa City VA Health Care System, Iowa City, IA; 🇺🇸 Iowa City, Iowa, United States

Michael E. DeBakey VA Medical Center, Houston, TX; 🇺🇸 Houston, Texas, United States