AUD: Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
Study Details
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 |
|---|---|---|
| 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
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 Names:
|
| Active Comparator: Arm 2 naltrexone |
Drug: Naltrexone
25mg per day, taken by mouth for 7 days, then 50mg per day
Other Names:
|
Outcome Measures
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. [24 weeks]
Eligibility Criteria
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Iowa City VA Health Care System, Iowa City, IA | Iowa City | Iowa | United States | 52246-2208 |
| 2 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D7201-I
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm 1 | Arm 2 |
|---|---|---|
| Arm/Group Description | sodium valproate 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 Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day |
| Period Title: Overall Study | ||
| STARTED | 31 | 31 |
| COMPLETED | 31 | 31 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Arm/Group Description | sodium valproate 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 Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day | Total of all reporting groups |
| Overall Participants | 31 | 31 | 62 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
31
100%
|
31
100%
|
62
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
46.71
(9.52)
|
48.13
(8.79)
|
47.42
(9.17)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
31
100%
|
31
100%
|
62
100%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
31
100%
|
31
100%
|
62
100%
|
Outcome Measures
| 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. |
|---|---|
| Description | |
| Time Frame | 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm 1 | Arm 2 |
|---|---|---|
| Arm/Group Description | sodium valproate 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 Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day |
| Measure Participants | 31 | 31 |
| Mean (Standard Deviation) [Weeks] |
8.78
(0.97)
|
15.99
(1.36)
|
Adverse Events
| Time Frame | 6 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Arm 1 | Arm 2 | ||
| Arm/Group Description | sodium valproate 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 Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day | ||
All Cause Mortality |
||||
| Arm 1 | Arm 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Arm 1 | Arm 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/31 (0%) | 0/31 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Arm 1 | Arm 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/31 (38.7%) | 10/31 (32.3%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 3/31 (9.7%) | 9/31 (29%) | ||
| Diarrhea | 10/31 (32.3%) | 9/31 (29%) | ||
| Abdominal Pain | 3/31 (9.7%) | 5/31 (16.1%) | ||
| Nervous system disorders | ||||
| Drowsiness | 12/31 (38.7%) | 10/31 (32.3%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Sweating | 5/31 (16.1%) | 10/31 (32.3%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Ricardo Jorge |
|---|---|
| Organization | Michael E. DeBakey VAMC |
| Phone | 713-794-7010 |
| ricardo.jorge@va.gov |
- D7201-I