Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

NCT01342549 | Completed Phase 3 Results DMC

• 1 other identifier: D7201-I
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcohol Dependence

Keywords

Alcohol Use Disorders; Traumatic Brain Injury; Mood and Anxiety Disorders

Outcome Measures

Primary Outcomes (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.

  24 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

sodium valproate

Drug: Valproate

Arm 2

ACTIVE COMPARATOR

naltrexone

Drug: Naltrexone

Interventions

Valproate DRUG

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

Also known as: Depakote ER

Arm 1

Naltrexone DRUG

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

Also known as: Revia

Arm 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Alcoholism; Brain Injuries, Traumatic; Anxiety Disorders

Interventions

Valproic Acid; Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Ricardo Jorge
• Organization: Michael E. DeBakey VAMC

ricardo.jorge@va.gov

713-794-7010

Study Officials

• Ricardo E Jorge, MD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 27, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 9, 2016
• Results First Posted: June 9, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)