Phase 3
Completed N=62
Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
Source: ClinicalTrials.gov NCT01342549 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: 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. — 8.78; 15.99 Weeks
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
8.78; 15.99 | — |
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
Data sourced from ClinicalTrials.gov (NCT01342549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.