Aripiprazole Effects on Alcohol Reactivity and Consumption

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer) is effective in reducing of alcohol craving compared to placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Aripiprazole; Ethanol

Criteria

Inclusion Criteria:

• 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 Criteria:

1. Currently meets DSM IV criteria for any other psychoactive substance dependence disorder.

2. 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.

3. 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.

4. Has current suicidal ideation or homicidal ideation.

5. Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications.

6. Current use of disulfiram.

7. Clinically significant medical problems such as, cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion.

8. Past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.

9. Hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2 1/2 times normal at screening.

10. Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.

11. Has current charges pending for a violent crime (not including DUI related offenses).

12. Does not have a stable living situation.