Mifepristone Treatment of Alcohol Use Disorder
Condition: Alcohol Dependence; Alcohol Use Disorders; Alcohol Abuse; Alcoholism
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Mifepristone 1200 mg daily; Standardized behavioral therapy; Placebo
Intervention description: Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.; Standardized behavioral therapy 1 time per week for 8 week duration.; Placebo tablets, Four tablets daily/am for 1-week duration.
Intervention MeSH terms: Mifepristone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcohol-Related Disorders; Substance-Related Disorders; Mental Disorders; Mifepristone; Glucocorticoid Antagonists; Alcohol Treatment; Alcohol

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.
    

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