Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2014-09-30
2019-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental: mifepristone 1200 mg daily
1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Mifepristone 1200 mg daily
Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.
Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 8 week duration.
Placebo daily, 1-week
Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 8 week duration.
Placebo
Placebo tablets, Four tablets daily/am for 1-week duration.
Interventions
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Mifepristone 1200 mg daily
Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.
Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 8 week duration.
Placebo
Placebo tablets, Four tablets daily/am for 1-week duration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
The Scripps Research Institute
OTHER
Responsible Party
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Principal Investigators
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Barbara J. Mason, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Scripps Research Institute
Locations
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The Scripps Research Institute
La Jolla, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol -IND
Document Type: Statistical Analysis Plan: Statistical Analysis Plan
Document Type: Informed Consent Form: Informed Consent
Other Identifiers
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