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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01342549
First received: April 25, 2011
Last updated: October 25, 2013
Last verified: October 2013
  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:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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: July 2014
Estimated Primary Completion Date: July 2014 (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 65 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342549

Locations
United States, Iowa
Iowa City VA Medical Center, 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
Investigators
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 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Alcohol Use Disorders
Traumatic Brain Injury
Mood and Anxiety Disorders

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Valproic Acid
Naltrexone
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 14, 2014