Mifepristone Treatment of Alcohol Use Disorder

Alcoholism Clinical Trial

Official title:

Glucocorticoid Antagonist Treatment of Alcohol Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179749
• Other study ID #: 1R01AA023152
• Status: Completed
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: November 6, 2019

Study information

• Verified date: September 2022
• Source: The Scripps Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: November 6, 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcohol Drinking
• Alcohol Use Disorders
• Alcoholism
• Disease

Intervention

Drug:
• Mifepristone 1200 mg daily
Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.

Behavioral:
• Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 8 week duration.

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

Locations

Country	Name	City	State
United States	The Scripps Research Institute	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
The Scripps Research Institute	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	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	Craving	Alcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol.	Participants will be followed for up to 12 weeks