Aripiprazole Effects on Alcohol Drinking and Craving

July 7, 2017 updated by: Raymond F. Anton, Medical University of South Carolina

Impulsivity and Drinking/Craving: Effect of a Dopamine Stabilizer Medication

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Non-treatment seeking individuals meeting criteria for alcohol dependence (N=120) will be recruited through advertisement and paid for their participation. Subjects will have blood drawn for DNA analysis of various brain dopamine system genes. Alcoholics, after baseline evaluation, will be assigned through urn randomization to one of two experimental groups, depending on their baseline level of impulsivity, 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 (functional magnetic resonance imaging) brain scan with cue stimulation on day 7, on the evening before the alcohol administration paradigm. fMRI (functional magnetic resonance) imaging 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.

Whether dopamine system genetic differences will be predict drinking, nucleus accumbens activity, and aripiprazole response will be explored.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 3

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
        • Medical University of South Carolina, Institute of Psychiatry, Center for Drug and Alcohol Programs

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

21 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sugar pill
Drug: Placebo
Placebo to match active drug Aripiprazole for 8 days
Active Comparator: Aripiprazole
Medication
Drug: Aripiprazole
Aripiprazole(up to 15 mg/day) for 8 days
Other Names:
  • Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Drinks Per Day During Natural (Usual Environment) Conditions
Time Frame: 6-day observation period
"Natural" alcohol consumption period -- drinks per day consumed during the 6-day observation period
6-day observation period
Total Number of Drinks Consumed in Bar Lab
Time Frame: 2 hours during the bar lab paradigm
This measure refers to a "bar lab" paradigm in which individuals received an initial "priming" drink of alcohol, targeted to produce a breath alcohol concentration (BrAC) of 30 mg%, and could then choose to consume up to 8 additional drinks, each targeted to produce a BrAC of 15 mg%, during the subsequent 2 hours. Thus, the total number of drinks consumed could range between 0 and 8.
2 hours during the bar lab paradigm

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)

Investigators

  • Principal Investigator: Raymond Anton, M.D., Medical University of South Carolian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

February 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

July 7, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIH P50 AA010761
  • P50AA010761 (U.S. NIH Grant/Contract)

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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