NCT00183235

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

May 5, 2010

Status Verified

May 1, 2010

First QC Date

September 13, 2005

Last Update Submit

May 4, 2010

Conditions

Alcohol Dependence

Keywords

Alcohol dependenceAlcoholismCraving

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Interventions

aripiprazole (up to 15 mg/day) for 8 daysDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Does not have metal objects in the head/neck.
  • Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.

You may not qualify if:

  • Currently meets DSM IV criteria for any other psychoactive substance dependence disorder.
  • 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.
  • 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.
  • Has current suicidal ideation or homicidal ideation.
  • Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications.
  • Current use of disulfiram.
  • Clinically significant medical problems such as, cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion.
  • Past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.
  • Hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2 1/2 times normal at screening.
  • Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
  • Has current charges pending for a violent crime (not including DUI related offenses).
  • Does not have a stable living situation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Raymond F. Anton, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

June 1, 2005

Study Completion

February 1, 2006

Last Updated

May 5, 2010

Record last verified: 2010-05

Locations

US(1)