Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

Alcohol Dependence Clinical Trial

— AUD  

Official title:

Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342549
• Other study ID #: D7201-I
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2011
• Last updated: August 20, 2015
• Start date: September 2011
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcohol Drinking
• Alcoholism

Intervention

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
• Naltrexone
25mg per day, taken by mouth for 7 days, then 50mg per day

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas
United States	Iowa City VA Health Care System, Iowa City, IA	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome variable will be time to relapse to heavy drinking	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.	24 weeks	No