Aripiprazole Effects on Alcohol Reactivity and Consumption

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00183235
First received: September 13, 2005
Last updated: May 4, 2010
Last verified: May 2010
  Purpose

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


Condition Intervention Phase
Alcohol Dependence
Drug: aripiprazole (up to 15 mg/day) for 8 days
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 30
Study Start Date: June 2005
Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00183235

Locations
United States, South Carolina
Center for Drug and Alcohol Programs, Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Raymond F. Anton, MD Medical University of South Carolina
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00183235     History of Changes
Other Study ID Numbers: NIAAAANT010761-2005b, P50AA010761, NIH P50 AA010761
Study First Received: September 13, 2005
Last Updated: May 4, 2010
Health Authority: United States: Federal Government

Keywords provided by Medical University of South Carolina:
Alcohol dependence
Alcoholism
Craving

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 September 22, 2014