A Phase 3 interventional study of Valproate and Naltrexone in Alcohol Dependence, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-06-09.
Sponsored by VA Office of Research and Development · Phase 3, Interventional, and Treatment
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.
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 62 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
sodium valproate
Drug: Valproate
naltrexone
Drug: Naltrexone
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
25mg per day, taken by mouth for 7 days, then 50mg per day
Also known as: Revia
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
| Milestone | Arm 1 | Arm 2 |
|---|---|---|
| Started | 31 | 31 |
| Completed | 31 | 31 |
| Not completed | 0 | 0 |
| Weeks | Arm 1 | Arm 2 |
|---|---|---|
| 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. | 8.78 ± 0.97 | 15.99 ± 1.36 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | — | 0/31 (0%) | 12/31 (38.7%) |
| Arm 2 | — | 0/31 (0%) | 10/31 (32.3%) |
| Event | Arm 1 | Arm 2 |
|---|---|---|
| DrowsinessNervous system disorders | 12/31 | 10/31 |
| DiarrheaGastrointestinal disorders | 10/31 | 9/31 |
| SweatingSkin and subcutaneous tissue disorders | 5/31 | 10/31 |
| NauseaGastrointestinal disorders | 3/31 | 9/31 |
| Abdominal PainGastrointestinal disorders | 3/31 | 5/31 |
1. Veterans age 18 to 60 2. Presence of a diagnosis of alcohol dependence (DSM-IV criteria); 3. A recent history of heavy drinking defined as 5 or more drinks in a sitting at least twice in a week during the previous 2 months;4. Absence of withdrawal symptoms CIWA-Ar (94);5. Presence of a knowledgeable informant
| Age, Categorical(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 31 | 31 | 62 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Mean | 46.71 ± 9.52 | 48.13 ± 8.79 | 47.42 ± 9.17 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 31 | 31 | 62 |
| Region of Enrollment(participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| United States | 31 | 31 | 62 |
Plan to share: No
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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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VA Office of Research and Development