Mifepristone Treatment of Alcohol Use Disorder

Phase 2

Completed

Conditions: Alcohol Abuse
Alcohol Use Disorders
Alcoholism
Alcohol Dependence

Interventions: Behavioral: Standardized behavioral therapy
Drug: Mifepristone 1200 mg daily
Drug: Placebo

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Placebo daily, 1-week	Placebo	Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Placebo daily, 1-week	Standardized behavioral therapy	Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Experimental: mifepristone 1200 mg daily	Mifepristone 1200 mg daily	1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Experimental: mifepristone 1200 mg daily	Standardized behavioral therapy	1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy

Primary Outcome Measures

Name	Time	Method
Drinking Quantity Per Day	Participants will be followed for up to 12 weeks post-assignment	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.

Secondary Outcome Measures

Name	Time	Method
Craving	Participants will be followed for up to 12 weeks	Alcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol.