Aripiprazole Effects on Alcohol Drinking and Craving

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01292057
Recruitment Status : Completed
First Posted : February 9, 2011
Results First Posted : July 7, 2017
Last Update Posted : August 8, 2017
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Raymond F. Anton, Medical University of South Carolina

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Aripiprazole Drug: Placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Impulsivity and Drinking/Craving: Effect of a Dopamine Stabilizer Medication
Study Start Date : February 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Aripiprazole
Drug: Aripiprazole
Aripiprazole(up to 15 mg/day) for 8 days
Other Name: Abilify
Placebo Comparator: Sugar pill Drug: Placebo
Placebo to match active drug Aripiprazole for 8 days

Primary Outcome Measures :
  1. 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

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01292057

United States, South Carolina
Medical University of South Carolina, Institute of Psychiatry, Center for Drug and Alcohol Programs
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Raymond Anton, M.D. Medical University of South Carolian

Additional Information:
Responsible Party: Raymond F. Anton, Professor, Medical University of South Carolina Identifier: NCT01292057     History of Changes
Other Study ID Numbers: NIH P50 AA010761
P50AA010761 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2011    Key Record Dates
Results First Posted: July 7, 2017
Last Update Posted: August 8, 2017
Last Verified: July 2017

Keywords provided by Raymond F. Anton, Medical University of South Carolina:
brain imaging

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs