Mifepristone Treatment of Alcohol Use Disorder
Primary Purpose
Alcohol Dependence, Alcohol Use Disorders, Alcohol Abuse
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mifepristone 1200 mg daily
Standardized behavioral therapy
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders, Mifepristone, Glucocorticoid Antagonists, Alcohol Treatment, Alcohol
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
Sites / Locations
- The Scripps Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Experimental: mifepristone 1200 mg daily
Placebo daily, 1-week
Arm Description
1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Craving
Alcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol.
Full Information
NCT ID
NCT02179749
First Posted
June 26, 2014
Last Updated
September 8, 2022
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT02179749
Brief Title
Mifepristone Treatment of Alcohol Use Disorder
Official Title
Glucocorticoid Antagonist Treatment of Alcohol Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Alcohol Use Disorders, Alcohol Abuse, Alcoholism
Keywords
Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders, Mifepristone, Glucocorticoid Antagonists, Alcohol Treatment, Alcohol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: mifepristone 1200 mg daily
Arm Type
Active Comparator
Arm Description
1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Arm Title
Placebo daily, 1-week
Arm Type
Placebo Comparator
Arm Description
Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Intervention Type
Drug
Intervention Name(s)
Mifepristone 1200 mg daily
Other Intervention Name(s)
Korlym
Intervention Description
Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.
Intervention Type
Behavioral
Intervention Name(s)
Standardized behavioral therapy
Other Intervention Name(s)
Manually-guided therapy
Intervention Description
Standardized behavioral therapy 1 time per week for 8 week duration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo tablets, Four tablets daily/am for 1-week duration.
Primary Outcome Measure Information:
Title
Drinking Quantity Per Day
Description
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.
Time Frame
Participants will be followed for up to 12 weeks post-assignment
Secondary Outcome Measure Information:
Title
Craving
Description
Alcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol.
Time Frame
Participants will be followed for up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J. Mason, Ph.D
Organizational Affiliation
The Scripps Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Scripps Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mifepristone Treatment of Alcohol Use Disorder
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