Aripiprazole Effects on Alcohol Reactivity and Consumption

May 4, 2010 updated by: Medical University of South Carolina

Effectiveness of Aripiprazole to Reduce Craving for Alcohol and Drinking Under Natural Observation, During Cue Induced Brain Imaging, and During a Motivated Free Choice Drinking Procedure Compared to Placebo

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 be assigned through urn randomization to one of two experimental groups in which they will receive either aripiprazole (up to 15 mg/day) or an identical placebo. Subjects will take the study drug or placebo for 8 days (day 1-6 being the natural observation period). After a minimum of 24 hours of abstinence from alcohol (day 7-8) they will undergo an alcohol administration (priming dose) and motivated free choice drinking procedure (on day 8). Alcoholic subjects will receive a brief counseling session at the end of the study to enhance their awareness of problem drinking and to motivate them to seek treatment. Referral for treatment will be offered.

Each subject will undergo a functional MRI brain scan with cue stimulation on day 7, on the evening before the alcohol administration paradigm. fMRI brain imaging technology will be used to determine if alcoholics treated with aripiprazole differ in alcohol cue-induced activity in the nucleus accumbens. It is hypothesized that aripiprazole will reduce nucleus accumbens activation to alcohol cues compared to placebo.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Center for Drug and Alcohol Programs, Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
For the Efficacy Hypotheses, the primary dependent variables are
(First) "Natural" alcohol consumption period -- total number of drinks consumed during the 5-day observation period
(Second) Limited access alcohol consumption paradigm -- Total number of drinks consumed
(Third) Activation of nucleus accumbens after cue stimulation
For the Safety and Tolerability Hypotheses, the primary dependent variables are
(First) Number of drop-outs due to adverse events
(Second) Number of side effects on symptom checklist
(Third) Change in liver function as indicated by ALT, AST

Secondary Outcome Measures

Outcome Measure
Blood alcohol levels after priming drink
Average BAES stimulation score
SHAS score after alcohol priming drink
Change in POMS sub-scale scores
Change in Epworth Sleepiness Scale
Differential effects on the Quality of Sleep Scale
Craving (OCDS) change between day 1 and 6
Craving after alcohol priming

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

May 5, 2010

Last Update Submitted That Met QC Criteria

May 4, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAANT010761-2005b
  • P50AA010761 (U.S. NIH Grant/Contract)
  • NIH P50 AA010761

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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