Treatment Strategy for Alcohol Use Disorders in Veterans With TBI (AUD)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01342549 |
Recruitment Status :
Completed
First Posted : April 27, 2011
Results First Posted : June 9, 2016
Last Update Posted : June 9, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcohol Dependence | Drug: Valproate Drug: Naltrexone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Treatment Strategy for Alcohol Use Disorders in Veterans With TBI |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
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
naltrexone
|
Drug: Naltrexone
25mg per day, taken by mouth for 7 days, then 50mg per day
Other Name: Revia |
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Principal Investigator: | Ricardo E Jorge, MD | Michael E. DeBakey VA Medical Center, Houston, TX |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT01342549 |
Other Study ID Numbers: |
D7201-I |
First Posted: | April 27, 2011 Key Record Dates |
Results First Posted: | June 9, 2016 |
Last Update Posted: | June 9, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Alcohol Use Disorders Traumatic Brain Injury Mood and Anxiety Disorders |
Alcoholism Alcohol Drinking Drinking Behavior Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Naltrexone Valproic Acid Alcohol Deterrents Narcotic Antagonists Physiological Effects of Drugs |
Sensory System Agents Peripheral Nervous System Agents Anticonvulsants Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |