search
Back to results

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

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Valproate
Naltrexone
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol Use Disorders, Traumatic Brain Injury, Mood and Anxiety Disorders

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Iowa City VA Health Care System, Iowa City, IA
  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

sodium valproate

naltrexone

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2011
Last Updated
May 2, 2016
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT01342549
Brief Title
Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
Acronym
AUD
Official Title
Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol Use Disorders, Traumatic Brain Injury, Mood and Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
sodium valproate
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
naltrexone
Intervention Type
Drug
Intervention Name(s)
Valproate
Other Intervention Name(s)
Depakote ER
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Revia
Intervention Description
25mg per day, taken by mouth for 7 days, then 50mg per day
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo E Jorge, MD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa City VA Health Care System, Iowa City, IA
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246-2208
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

We'll reach out to this number within 24 hrs