Status:
COMPLETED
Aripiprazole Effects on Alcohol Reactivity and Consumption
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer) is effective in reducing of alcohol craving compared to placebo.
Detailed Description
Non-treatment seeking individuals meeting criteria for alcohol dependence (N=30) will be recruited through advertisement and paid for their participation. Alcoholics, after baseline evaluation, will b...
Eligibility Criteria
Inclusion
- Age 21 - 65
- Meets the DSM IV criterion for current alcohol dependence including "loss of control over drinking" (criterion 3 and/or 4).
- Currently is not engaged in, and does not want treatment for, alcohol related problems.
- Able to read and understand questionnaires and informed consent.
- Lives within 50 miles of the study site.
- Able to maintain abstinence for up to two days (without the aid of detox medications) as determined by self report and breathalyzer measurements.
- \*Inclusion for fMRI imaging:
- Does not have metal objects in the head/neck.
- Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.
Exclusion
- Currently meets DSM IV criteria for any other psychoactive substance dependence disorder.
- Any psychoactive substance use (except marijuana and nicotine) within the last 30 days as evidenced by self-report and urine drug screen. For marijuana - no use within the last seven days.
- 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, dissociate disorders and eating disorders, any other psychotic disorder or organic mental disorder.
- 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.
- Past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.
- Hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2 1/2 times normal at screening.
- Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00183235
Start Date
June 1 2005
End Date
February 1 2006
Last Update
May 5 2010
Active Locations (1)
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1
Center for Drug and Alcohol Programs, Medical University of South Carolina
Charleston, South Carolina, United States, 29425