Mifepristone Treatment of Alcohol Use Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Glucocorticoid Antagonist Treatment of Alcohol Use Disorder

Conditions
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Alcohol Abuse, Alcohol Dependence, Alcohol Use Disorders, Alcoholism

Intervention / Treatment
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* Drug: Mifepristone 1200 mg daily
* Behavioral: Standardized behavioral therapy
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental: mifepristone 1200 mg daily<br>1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy | Drug: Mifepristone 1200 mg daily<br>* Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.<br>* Other names: Korlym;Behavioral: Standardized behavioral therapy<br>* Standardized behavioral therapy 1 time per week for 8 week duration.<br>* Other names: Manually-guided therapy;|
| Placebo Comparator: Placebo daily, 1-week<br>Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy | Behavioral: Standardized behavioral therapy<br>* Standardized behavioral therapy 1 time per week for 8 week duration.<br>* Other names: Manually-guided therapy;Drug: Placebo<br>* Placebo tablets, Four tablets daily/am for 1-week duration.<br>* Other names: Placebo Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders, Mifepristone, Glucocorticoid Antagonists, Alcohol Treatment, Alcohol