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

• ClinicalTrials.gov Identifier: NCT01342549
• Recruitment Status: Completed
• First Posted: April 27, 2011
• Results First Posted: June 9, 2016
• Last Update Posted: June 9, 2016
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Alcohol Dependence	Drug: Valproate; Drug: Naltrexone	Phase 3

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 Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes 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

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
• Other Study ID Numbers: D7201-I
• First Posted: April 27, 2011
• 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

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; 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