Status:
COMPLETED
An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 cli...
Eligibility Criteria
Inclusion
- Age 18 70
- 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
- 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)
- 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
- Able to read and understand questionnaires and informed consent
- Lives within approximately 50 miles of the study site -
Exclusion
- Currently meets DSM IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
- Ever abused opiates
- Any psychoactive substance abuse, except marijuana and nicotine, within the last 30 days as evidenced by subject report, collateral report, or urine drug screen
- 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
- Meets DSM IV current criteria for dissociative disorder or eating disorders
- Has current suicidal ideation or homicidal ideation
- Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications
- Current use of disulfiram
- Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion
- 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
- 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
- Has current charges pending for a violent crime (not including DUI-related offenses)
- Does not have a stable living situation and a reliable source of collateral reporting
- Has taken an opiate antagonist drug in the last month
- Has taken aripiprazole in the last month or has experienced adverse effects from it at any time in the past
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00667875
Start Date
April 1 2008
End Date
May 1 2011
Last Update
September 29 2017
Active Locations (1)
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1
Medical University of South Carolina, Center for Drug and Alcohol Programs
Charleston, South Carolina, United States, 29425