Treatment Strategy for Alcohol Use Disorders in Veterans With TBI (AUD)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Treatment Strategy for Alcohol Use Disorders in Veterans With TBI|
- Primary outcome variable will be time to relapse to heavy drinking [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Primary Outcome variable will be 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. The time frame will be the week previous to the evaluation. Thus, a structured questionnaire will review the amount of alcohol that the patient had consumed on each of the days of the previous week.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1
250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day
Active Comparator: Arm 2
25mg per day, taken by mouth for 7 days, then 50mg per day
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.
|United States, Iowa|
|Iowa City VA Medical Center, Iowa City, IA|
|Iowa City, Iowa, United States, 52246-2208|
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ricardo E. Jorge, MD||Michael E. DeBakey VA Medical Center, Houston, TX|