Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

Completed · Phase 3

Conditions studied: Alcohol Dependence

In brief

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.

Key facts

Study ID

NCT01342549

Run by

VA Office of Research and Development

People needed

62

Starts

2011-09-01

Expected to finish

2015-06-01

Last updated by the study team

2016-06-09

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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