Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-07-31

Brief Summary

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The primary hypotheses under test are that alcohol dependent subjects treated with mifepristone will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.

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Detailed Description

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Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Korlym (mifepristone)

600 mg daily taken orally for one week

Group Type ACTIVE_COMPARATOR

Korlym (mifepristone)

Intervention Type DRUG

600 mg/day, oral pill, 7 days

Sugar Pill

placebo pill daily taken orally for one week

Group Type PLACEBO_COMPARATOR

Sugar Pill

Intervention Type DRUG

600 mg/day, oral pill, 7 days

Interventions

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Korlym (mifepristone)

600 mg/day, oral pill, 7 days

Intervention Type DRUG

Sugar Pill

600 mg/day, oral pill, 7 days

Intervention Type DRUG

Other Intervention Names

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Mifepristone C-1073 Mifeprex RU-486 Placebo

Eligibility Criteria

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Inclusion Criteria

* Male or female volunteers, 18-65 years of age
* Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Addition (DSM-IV) criteria for current alcohol dependence
* Subjects will not be seeking treatment because the medication studies are not treatment trials
* Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session
* Negative Breath Alcohol Concentration (BAC) and a Clinical Institute Withdrawal Assessment-Alcohol (CIWA-A) score of \< 8 at screening and time of lab session to eliminate acute alcohol or withdrawal effects on dependent measures
* Subjects must be able to complete and understand questionnaires and study procedures in English and sign an informed consent

Exclusion Criteria

* Significant medical disorders that will increase potential risk or interfere with study participation as determined by the Study Physician
* Female subjects with childbearing potential who are pregnant, nursing, or refuse to use double barrier (non-hormonal) methods of birth control for the duration of the study and one month thereafter
* Meets DSM-IV criteria for a major Axis I disorder including mood or anxiety disorders or substance dependence disorders other than alcohol or nicotine dependence
* History of allergy or hypersensitivity to the study drugs or the ingredients
* Treatment within the month prior to screening with 1.) an investigational drug or vaccine; 2.) drugs that may influence study outcomes, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), anticonvulsants, antidepressants.
* In need of or currently taking any psychoactive medications.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No