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Mifepristone Treatment of Alcohol Use Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Mifepristone Treatment of Alcohol Use Disorder

Glucocorticoid Antagonist Treatment of Alcohol Use Disorder

NCT02179749•The Scripps Research Institute

Summary

This is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups, study of 1-week of treatment with mifepristone (0, 1200 mg/d) given in conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female volunteers, 18-65 years of age
•Meets Diagnostic and Statistical Manual (DSM)-V criteria for current alcohol use disorder of moderate or greater severity, defined by DSM-V as ≥ 4 symptoms
•Abstinent a minimum of 3 days (but not more than 30 days) prior to randomization
•In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, ECG, urine test and lab tests
•Females with childbearing potential must have a negative serum pregnancy test on the screening visit and a negative urine pregnancy test at randomization and agree to use non-hormonal effective birth control for the study duration and one month thereafter

Exclusion Criteria

•A medical condition or chronic use of a medication that contraindicates the administration of mifepristone
•Significant medical disorders or clinically significant findings on ECG (e.g., prolongation of the corrected QT interval,urine or blood tests that increase potential risk or interfere with study participation as determined by the Study Physician. Note: serum potassium below the normal range must be replaced to normal prior to randomization; individuals with serum potassium outside the range of normal will not be randomized
•Liver function tests more than 3 times the upper limit of normal or elevated bilirubin
•Female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective non hormonal birth control for the 1-week of medication administration and one month thereafter
•Meets Diagnostic and Statistical Manual -V criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders other than alcohol or nicotine use disorders

Locations (1)

The Scripps Research Institute

La Jolla, California, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

November 1, 2019

Completion Date

November 6, 2019

Last Updated

October 6, 2022

Enrollment

103

ACTUAL participants

Conditions

Alcohol DependenceAlcohol Use DisordersAlcohol AbuseAlcoholism

Interventions

Mifepristone 1200 mg daily

DRUG

Standardized behavioral therapy

BEHAVIORAL

Placebo

DRUG

Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder

NCT06939088

Alcohol Use DisorderAlcohol Abuse/Dependence+6 more

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RECRUITINGNA

Virtual Incentive Treatment for Alcohol

NCT06265506

Alcohol Use DisorderAlcohol Drinking+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Mifepristone Treatment of Alcohol Use Disorder

Inclusion Criteria

Exclusion Criteria

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