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Aripiprazole Effects on Alcohol Reactivity and Consumption

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aripiprazole (up to 15 mg/day) for 8 days
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol dependence, Alcoholism, Craving

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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.

Sites / Locations

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

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
May 4, 2010
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00183235
Brief Title
Aripiprazole Effects on Alcohol Reactivity and Consumption
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol dependence, Alcoholism, Craving

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
aripiprazole (up to 15 mg/day) for 8 days
Primary Outcome Measure Information:
Title
For the Efficacy Hypotheses, the primary dependent variables are
Title
(First) "Natural" alcohol consumption period -- total number of drinks consumed during the 5-day observation period
Title
(Second) Limited access alcohol consumption paradigm -- Total number of drinks consumed
Title
(Third) Activation of nucleus accumbens after cue stimulation
Title
For the Safety and Tolerability Hypotheses, the primary dependent variables are
Title
(First) Number of drop-outs due to adverse events
Title
(Second) Number of side effects on symptom checklist
Title
(Third) Change in liver function as indicated by ALT, AST
Secondary Outcome Measure Information:
Title
Blood alcohol levels after priming drink
Title
Average BAES stimulation score
Title
SHAS score after alcohol priming drink
Title
Change in POMS sub-scale scores
Title
Change in Epworth Sleepiness Scale
Title
Differential effects on the Quality of Sleep Scale
Title
Craving (OCDS) change between day 1 and 6
Title
Craving after alcohol priming

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond F. Anton, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Drug and Alcohol Programs, Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Aripiprazole Effects on Alcohol Reactivity and Consumption

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