Treatment Strategy for Alcohol Use Disorders in Veterans With TBI - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Alcohol

Drug Information available for: Valproic acid Valproate sodium Naltrexone Naltrexone hydrochloride Divalproex sodium

U.S. FDA Resources

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 naltrexone	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.

Eligibility


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

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

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 ClinicalTrials.gov identifier: NCT01342549

Locations


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

Investigators


Principal Investigator:	Ricardo E Jorge, MD	Michael E. DeBakey VA Medical Center, Houston, TX

More Information


Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov 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:


Alcoholism Alcohol Drinking Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Drinking Behavior Ethanol Valproic Acid Naltrexone Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants	Physiological Effects of Drugs Narcotic Antagonists Sensory System Agents Peripheral Nervous System Agents Anticonvulsants Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Antimanic Agents Tranquilizing Agents Psychotropic Drugs

ClinicalTrials.gov processed this record on September 23, 2016

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