Mifepristone Treatment of Alcohol Use Disorder

NCT02179749 | Completed Phase 2 Results

• 1 other identifier: 1R01AA023152
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Dependence; Alcohol Use Disorders; Alcohol Abuse; Alcoholism

Keywords

Alcohol-Related Disorders; Substance-Related Disorders; Mental Disorders; Mifepristone; Glucocorticoid Antagonists; Alcohol Treatment; Alcohol

Outcome Measures

Primary Outcomes (1)

• Drinking Quantity Per Day

  Drinking quantity in standard drinks per day is measured by the Timeline Followback interview. A standard drink contains 14 grams of alcohol, e.g., 1.5 ounces of distilled spirits, 5 ounces of wine, or 12 ounces of beer.

  Participants will be followed for up to 12 weeks post-assignment

Secondary Outcomes (1)

• Craving

  Participants will be followed for up to 12 weeks

Study Arms (2)

Experimental: mifepristone 1200 mg daily

ACTIVE COMPARATOR

1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy

Drug: Mifepristone 1200 mg daily; Behavioral: Standardized behavioral therapy

Placebo daily, 1-week

PLACEBO COMPARATOR

Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy

Behavioral: Standardized behavioral therapy; Drug: Placebo

Interventions

Mifepristone 1200 mg daily DRUG

Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.

Also known as: Korlym

Experimental: mifepristone 1200 mg daily

Standardized behavioral therapy BEHAVIORAL

Standardized behavioral therapy 1 time per week for 8 week duration.

Also known as: Manually-guided therapy

Experimental: mifepristone 1200 mg daily; Placebo daily, 1-week

Placebo DRUG

Placebo tablets, Four tablets daily/am for 1-week duration.

Also known as: Placebo Comparator

Placebo daily, 1-week

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Scripps Research Institute: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

The Scripps Research Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Mental Disorders

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Barbara J. Mason, Ph.D.
• Organization: The Scripps Research Institute

mason@scripps.edu

858-784-7328

Study Officials

• Barbara J. Mason, Ph.D

  The Scripps Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: July 2, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: November 6, 2019
• Last Updated: October 6, 2022
• Results First Posted: October 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)