Mifepristone Treatment of Alcohol Use Disorder

Glucocorticoid Antagonist Treatment of Alcohol Use Disorder

Sponsors

Lead Sponsor: The Scripps Research Institute

Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Source The Scripps Research Institute
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.

Overall Status Completed
Start Date 2014-09-01
Completion Date 2019-11-06
Primary Completion Date 2019-11-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Drinking Participants will be followed for up to 8 weeks
Secondary Outcome
Measure Time Frame
Craving Participants will be followed for up to 8 weeks
Enrollment 103
Condition
Intervention

Intervention Type: Drug

Intervention Name: Mifepristone 1200 mg daily

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

Arm Group Label: Experimental: mifepristone 1200 mg daily

Other Name: Korlym

Intervention Type: Behavioral

Intervention Name: Standardized behavioral therapy

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

Other Name: Manually-guided therapy

Intervention Type: Drug

Intervention Name: Placebo

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

Arm Group Label: Placebo daily, 1-week

Other Name: Placebo Comparator

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Barbara J. Mason, Ph.D Principal Investigator The Scripps Research Institute
Location
Facility: The Scripps Research Institute
Location Countries

United States

Verification Date

2021-03-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Experimental: mifepristone 1200 mg daily

Type: Active Comparator

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

Label: Placebo daily, 1-week

Type: Placebo Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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