Treatment Strategy for Alcohol Use Disorders in Veterans With TBI (AUD)

VA Office of Research and Development

Status and phase

Completed

Phase 3

Conditions

Alcohol Dependence

Treatments

Drug: Naltrexone

Drug: Valproate

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01342549

D7201-I

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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