Alcohol Dependence
Conditions
Keywords
Alcohol Use Disorders, Traumatic Brain Injury, Mood and Anxiety Disorders
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.
Interventions
DRUGValproate
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
DRUGNaltrexone
25mg per day, taken by mouth for 7 days, then 50mg per day
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 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 | 31 |
| Arm 2 naltrexone
Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day | 31 |
| Total | 62 |
Baseline characteristics
| Characteristic | Arm 2 | Arm 1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 31 Participants | 62 Participants |
| Age, Continuous | 48.13 years STANDARD_DEVIATION 8.79 | 46.71 years STANDARD_DEVIATION 9.52 | 47.42 years STANDARD_DEVIATION 9.17 |
| Region of Enrollment United States | 31 participants | 31 participants | 62 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 31 Participants | 31 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 31 | 10 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 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. | 8.78 Weeks | Standard Deviation 0.97 |
| 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. | 15.99 Weeks | Standard Deviation 1.36 |