Clinical trial NCT01342549: Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
Official title: Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Dependence
Keywords: Alcohol Use Disorders
Traumatic Brain Injury
Mood and Anxiety Disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-04-27
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Iowa City VA Health Care System, Iowa City, IA
state: Iowa
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Ricardo E Jorge, MD
role: PRINCIPAL_INVESTIGATOR
References: