An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/1/2017 |
| Start Date: | April 2008 |
| End Date: | May 2011 |
The principal aim of this exploratory study is to examine whether the addition of
aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week
randomized, placebo-controlled clinical trial, in which all subjects will be provided medical
management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication
treatment will reduce drinking compared to placebo treatment alone in the context of medical
management and whether naltrexone plus aripiprazole will reduce drinking compared to
naltrexone treatment alone in the context of medical management.
aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week
randomized, placebo-controlled clinical trial, in which all subjects will be provided medical
management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication
treatment will reduce drinking compared to placebo treatment alone in the context of medical
management and whether naltrexone plus aripiprazole will reduce drinking compared to
naltrexone treatment alone in the context of medical management.
Inclusion Criteria:
1. Age 18 70
2. Subjects will meet criteria for primary alcohol dependence operationalized as follows:
A. Meets the DSM IV criteria for alcohol dependence including loss of control over
drinking (criterion 3) B. Has not had more than one previous inpatient medical
detoxification
3. Consumes, on average, at least 10 standard drinks per drinking day for men and 8
drinks per day for women in the 90 days pre-screening (to select an appropriately
heavy drinking population)
4. Able to maintain sobriety for four days (with or without the aid of alcohol
detoxification medications) as determined by self report, collateral report, and
breathalyzer measurements
5. Able to read and understand questionnaires and informed consent
6. Lives within approximately 50 miles of the study site -
Exclusion Criteria:
1. Currently meets DSM IV criteria for any other psychoactive substance dependency
disorder except nicotine dependence
2. Ever abused opiates
3. Any psychoactive substance abuse, except marijuana and nicotine, within the last 30
days as evidenced by subject report, collateral report, or urine drug screen
4. Meets DSM IV criteria for current axis I disorders of major depression, panic
disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar
affective disorder, schizophrenia, or any other psychotic disorder or organic mental
disorder
5. Meets DSM IV current criteria for dissociative disorder or eating disorders
6. Has current suicidal ideation or homicidal ideation
7. Need for maintenance or acute treatment with any psychoactive medication including
anti-seizure medications
8. Current use of disulfiram
9. Clinically significant medical problems such as cardiovascular, renal, GI, or
endocrine problem that would impair participation or limit medication ingestion
10. Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at
least 3.0 times normal at screening and/or after 5 days abstinence
11. Sexually active female of child-bearing potential who is pregnant (by urine HCG),
nursing, or who is not using a reliable form of birth control
12. Has current charges pending for a violent crime (not including DUI-related offenses)
13. Does not have a stable living situation and a reliable source of collateral reporting
14. Has taken an opiate antagonist drug in the last month
15. Has taken aripiprazole in the last month or has experienced adverse effects from it at
any time in the past
We found this trial at
1
site
Charleston, South Carolina 29425
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