Aripiprazole Effects on Alcohol Drinking and Craving
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Aripiprazole; Placebo
Intervention description: Aripiprazole(up to 15 mg/day) for 8 days; Placebo to match active drug Aripiprazole for 8 days
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 99.0
Sex: All
Minimum age: 21 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Alcohol; Aripiprazole; Impulsivity; Alcoholism; drinking; treatment; craving; brain imaging; genetics

Summary:

      The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer)
      is effective in reducing of alcohol craving and drinking compared to placebo depending on
      participant's baseline level of impulsivity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 21 - 40 (to focus on an age group still on a trajectory of increasing alcohol
             consumption).

          2. Meets the DSM IV criteria for current alcohol dependence including criterion 3 and/or
             4 "loss of control over drinking" or "the inability to cut-down or stop drinking".

          3. Currently not engaged in, and does not want treatment for, alcohol related problems.

          4. Able to read and understand questionnaires and informed consent.

          5. Lives within 50 miles of the study site.

          6. Able to maintain abstinence for two days (without the aid of detoxification
             medications) as determined by self report and breathalyzer measurements.

        Inclusion for fMRI (functional magnetic resonance imaging) Imaging:

          1. Does not have metal objects in the head/neck.

          2. 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
             by self-report and urine drug screen. For marijuana, no use within the last seven days
             by verbal report and negative (or decreasing) urine THC (tetrahydrocannabinol) levels.

          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 and medications for ADHD (attention deficit hyperactivity
             disorder .

          6. Currently taking medication known to affect alcohol intake (e.g., disulfiram,
             naltrexone, acamprosate, topiramate).

          7. Clinically significant medical problems such as cardiovascular, renal, GI, or
             endocrine problems 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 2.5 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 (Driving Under
             Intoxication) related offenses).

         12. Does not have a stable living situation.