Aripiprazole Effects on Alcohol Drinking and Craving

Alcohol Dependence Clinical Trial

Official title:

Impulsivity and Drinking/Craving: Effect of a Dopamine Stabilizer Medication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292057
• Other study ID #: NIH P50 AA010761
• Secondary ID: P50AA010761
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2011
• Last updated: March 17, 2016
• Start date: February 2011
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Aripiprazole
Aripiprazole(up to 15 mg/day) for 8 days
• Placebo
Placebo to match active drug Aripiprazole for 8 days

Locations

Country	Name	City	State
United States	Medical University of South Carolina, Institute of Psychiatry, Center for Drug and Alcohol Programs	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total number of drinks per day during natural (usual environment) conditions	"Natural" alcohol consumption period -- drinks per day consumed during the 5-day observation period	5-day observation period	No
Primary	Total number of drinks under controlled conditions (bar lab)	Limited access alcohol consumption paradigm -- Total number of drinks consumed	2 hours during the alcohol challenge procedure	No

External Links

•   Alcoholism
•   Aripiprazole
•   Clinical trials
•   Ethanol