Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Anxiety Disorders Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Chemically-Induced Disorders Craniocerebral Trauma Mental Disorders Nervous System Diseases Substance-Related Disorders Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Iowa City VA Health Care System, Iowa City, IA, Iowa City, Iowa, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Valproate

Drug

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

Other names: Depakote ER

Naltrexone

Drug

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

Other names: Revia

Primary outcomes

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.

Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: AUD

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Apr 27, 2011
Registry last updated: Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed