NCT01292057

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_3

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

February 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 7, 2017

Completed
Last Updated

August 8, 2017

Status Verified

July 1, 2017

Enrollment Period

4.8 years

First QC Date

February 7, 2011

Results QC Date

June 8, 2017

Last Update Submit

July 7, 2017

Conditions

Alcohol Dependence

Keywords

AlcoholAripiprazoleImpulsivityAlcoholismdrinkingtreatmentcravingbrain imaginggenetics

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    2 hours during the bar lab paradigm

Study Arms (2)

Aripiprazole

ACTIVE COMPARATOR

Medication

Drug: Aripiprazole

Sugar pill

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AripiprazoleDRUG

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

Also known as: Abilify
Aripiprazole
PlaceboDRUG

Placebo to match active drug Aripiprazole for 8 days

Sugar pill

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • 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.

    PMID: 28493623BACKGROUND

Related Links

MeSH Terms

Conditions

AlcoholismImpulsive Behavior

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Joseph Schacht, Ph.D.
Organization
Medical University of South Carolina
schacht@musc.edu
(843) 792-7497

Study Officials

  • Raymond Anton, M.D.

    Medical University of South Carolian

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2011

First Posted

February 9, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 8, 2017

Results First Posted

July 7, 2017

Record last verified: 2017-07

Locations

US(1)