Aripiprazole Effects on Alcohol Drinking and Craving

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Medical University of South Carolina
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Raymond F. Anton, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01292057
First received: February 7, 2011
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Alcohol Dependence
Drug: Aripiprazole
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Impulsivity and Drinking/Craving: Effect of a Dopamine Stabilizer Medication

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • total number of drinks per day during natural (usual environment) conditions [ Time Frame: 5-day observation period ] [ Designated as safety issue: No ]
    "Natural" alcohol consumption period -- drinks per day consumed during the 5-day observation period

  • Total number of drinks under controlled conditions (bar lab) [ Time Frame: 2 hours during the alcohol challenge procedure ] [ Designated as safety issue: No ]
    Limited access alcohol consumption paradigm -- Total number of drinks consumed


Estimated Enrollment: 120
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aripiprazole
Medication
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292057

Contacts
Contact: Konstantin F. Voronin, MD, PhD 843-792-4887 voronin@musc.edu
Contact: Raymond F. Anton, MD 843-792-1226 antonr@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina, Institute of Psychiatry, Center for Drug and Alcohol Programs Recruiting
Charleston, South Carolina, United States, 29425
Contact: Konstantin E. Voronin, MD, PhD    843-792-4887    voronin@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Raymond Anton, M.D. Medical University of South Carolian
  More Information

Additional Information:
No publications provided

Responsible Party: Raymond F. Anton, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01292057     History of Changes
Other Study ID Numbers: NIH P50 AA010761, P50AA010761
Study First Received: February 7, 2011
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Alcohol
Aripiprazole
Impulsivity
Alcoholism
drinking
treatment
craving
brain imaging
genetics

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

ClinicalTrials.gov processed this record on October 19, 2014