Mifepristone Treatment of Alcohol Use Disorder

The Scripps Research Institute

Status and phase: Completed; Phase 2

Conditions: Alcoholism; Alcohol Abuse; Alcohol Use Disorders; Alcohol Dependence

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02179749

1R01AA023152

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 2 patient groups, including a placebo group

Experimental: mifepristone 1200 mg daily

Active Comparator group

Description:

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

Treatment:

Behavioral: Standardized behavioral therapy

Drug: Mifepristone 1200 mg daily

Placebo daily, 1-week

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Behavioral: Standardized behavioral therapy