Treatment Strategy for Alcohol Use Disorders in Veterans With TBI (AUD)
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Purpose
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 |
- 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.
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated 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 60mg per day. Usual dosage is between 1250mg to 2000mg per day
|
|
Active Comparator: Arm 2
naltrexone
|
Drug: Naltrexone
25mg per day, taken by mouth for 7 days, then 50mg per day
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01342549
| Contact: Ricardo E Jorge, MD | (319) 338-0581 | Ricardo.Jorge@va.gov | |
| Contact: Helen L Lin, PhD | (713) 791-1414 ext 24898 | helen.lin2@va.gov |
| United States, Iowa | |
| Iowa City VA Medical Center, Iowa City, IA | Recruiting |
| Iowa City, Iowa, United States, 52246-2208 | |
| Contact: Ricardo E Jorge, MD 319-338-0581 Ricardo.Jorge@va.gov | |
| Contact: Thomas Brashers-Krug Tom.Brashers-Krug@va.gov | |
| United States, Texas | |
| Michael E. DeBakey VA Medical Center, Houston, TX | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Laura A Petersen, MD MPH 713-794-8623 laura.petersen@va.gov | |
| Contact: Diana Nieto (713) 794-7920 dnieto@bcm.tmc.edu | |
| Principal Investigator: Ricardo E. Jorge, MD | |
| Principal Investigator: | Ricardo E. Jorge, MD | Michael E. DeBakey VA Medical Center, Houston, TX |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01342549 History of Changes |
| Other Study ID Numbers: | D7201-I |
| Study First Received: | April 25, 2011 |
| Last Updated: | October 2, 2014 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Alcohol Use Disorders Traumatic Brain Injury Mood and Anxiety Disorders |
ClinicalTrials.gov processed this record on March 03, 2015