- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01342549
Treatment Strategy for Alcohol Use Disorders in Veterans With TBI (AUD)
May 2, 2016 updated by: VA Office of Research and Development
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52246-2208
- Iowa City VA Health Care System, Iowa City, IA
-
-
Texas
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Houston, Texas, United States, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1
sodium 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 Names:
|
Active Comparator: Arm 2
naltrexone
|
25mg per day, taken by mouth for 7 days, then 50mg per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ricardo E Jorge, MD, Michael E. DeBakey VA Medical Center, Houston, TX
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
April 25, 2011
First Submitted That Met QC Criteria
April 26, 2011
First Posted (Estimate)
April 27, 2011
Study Record Updates
Last Update Posted (Estimate)
June 9, 2016
Last Update Submitted That Met QC Criteria
May 2, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Drinking Behavior
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcohol Drinking
- Alcoholism
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- GABA Agents
- Narcotic Antagonists
- Anticonvulsants
- Antimanic Agents
- Alcohol Deterrents
- Naltrexone
- Valproic Acid
Other Study ID Numbers
- D7201-I
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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