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

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: April 25, 2011
Last updated: May 2, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Alcohol Dependence
Drug: Valproate
Drug: Naltrexone
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: September 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
sodium valproate
Drug: Valproate
250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60 mg per kg per day. Usual dosage is between 1250mg to 2000mg per day
Other Name: Depakote ER
Active Comparator: Arm 2
Drug: Naltrexone
25mg per day, taken by mouth for 7 days, then 50mg per day
Other Name: Revia

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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01342549

United States, Iowa
Iowa City VA Health Care System, 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
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Ricardo E Jorge, MD Michael E. DeBakey VA Medical Center, Houston, TX
  More Information

Responsible Party: VA Office of Research and Development Identifier: NCT01342549     History of Changes
Other Study ID Numbers: D7201-I 
Study First Received: April 25, 2011
Results First Received: May 2, 2016
Last Updated: May 2, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
Alcohol Use Disorders
Traumatic Brain Injury
Mood and Anxiety Disorders

Additional relevant MeSH terms:
Alcohol Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior
Valproic Acid
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Tranquilizing Agents
Psychotropic Drugs processed this record on October 21, 2016