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Aripiprazole Effects on Alcohol Drinking and Craving

Primary Purpose

Alcohol Dependence

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Aripiprazole

Placebo

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol, Aripiprazole, Impulsivity, Alcoholism, drinking, treatment, craving, brain imaging, genetics

Eligibility Criteria

21 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 21 - 40 (to focus on an age group still on a trajectory of increasing alcohol consumption).
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".
Currently 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 two days (without the aid of detoxification medications) as determined by self report and breathalyzer measurements.

Inclusion for fMRI (functional magnetic resonance imaging) 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 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.
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 and medications for ADHD (attention deficit hyperactivity disorder .
Currently taking medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate).
Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problems 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 2.5 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 (Driving Under Intoxication) related offenses).
Does not have a stable living situation.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aripiprazole

Sugar pill

Arm Description

Medication

Outcomes

Primary Outcome Measures

Total Number of Drinks Per Day During Natural (Usual Environment) Conditions

"Natural" alcohol consumption period -- drinks per day consumed during the 6-day observation period

Total Number of Drinks Consumed in Bar Lab

This measure refers to a "bar lab" paradigm in which individuals received an initial "priming" drink of alcohol, targeted to produce a breath alcohol concentration (BrAC) of 30 mg%, and could then choose to consume up to 8 additional drinks, each targeted to produce a BrAC of 15 mg%, during the subsequent 2 hours. Thus, the total number of drinks consumed could range between 0 and 8.

Secondary Outcome Measures

Full Information

NCT ID

NCT01292057

First Posted

February 7, 2011

Last Updated

July 7, 2017

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT01292057

Brief Title

Aripiprazole Effects on Alcohol Drinking and Craving

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

Yes

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 and drinking compared to placebo depending on participant's baseline level of impulsivity.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Dependence

Keywords

Alcohol, Aripiprazole, Impulsivity, Alcoholism, drinking, treatment, craving, brain imaging, genetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aripiprazole

Arm Type

Active Comparator

Arm Description

Medication

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Aripiprazole

Other Intervention Name(s)

Abilify

Intervention Description

Aripiprazole(up to 15 mg/day) for 8 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to match active drug Aripiprazole for 8 days

Primary Outcome Measure Information:

Title

Total Number of Drinks Per Day During Natural (Usual Environment) Conditions

Description

"Natural" alcohol consumption period -- drinks per day consumed during the 6-day observation period

Time Frame

6-day observation period

Title

Total Number of Drinks Consumed in Bar Lab

Description

Time Frame

2 hours during the bar lab paradigm

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 21 - 40 (to focus on an age group still on a trajectory of increasing alcohol consumption). 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". Currently 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 two days (without the aid of detoxification medications) as determined by self report and breathalyzer measurements. Inclusion for fMRI (functional magnetic resonance imaging) 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 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. 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 and medications for ADHD (attention deficit hyperactivity disorder . Currently taking medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate). Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problems 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 2.5 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 (Driving Under Intoxication) related offenses). Does not have a stable living situation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raymond Anton, M.D.

Organizational Affiliation

Medical University of South Carolian

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28493623

Citation

Anton RF, Schacht JP, Voronin KE, Randall PK. Aripiprazole Suppression of Drinking in a Clinical Laboratory Paradigm: Influence of Impulsivity and Self-Control. Alcohol Clin Exp Res. 2017 Jul;41(7):1370-1380. doi: 10.1111/acer.13417. Epub 2017 Jun 5.

Results Reference

background

Links:

URL

http://www.nlm.nih.gov/medlineplus/

Description

Alcoholism

URL

http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp

Description

Ethanol

URL

http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp

Description

Aripiprazole

URL

http://clinicaltrials.gov/ct2/info/fdalinks

Description

Clinical trials

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Aripiprazole Effects on Alcohol Drinking and Craving

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