Treatment Strategy for Alcohol Use Disorders in Veterans With TBI



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:4/21/2016
Start Date:September 2011
End Date:June 2015

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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.

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 in Iowa, Illinois and Northern Missouri. Cooperation between
researchers and clinical staff will allow optimizing treatment strategies that enhance the
recovery of veterans with alcohol use disorders.

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
We found this trial at
2
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Iowa City, IA
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Houston, TX
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