Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Sugar Pill	Sugar Pill	placebo pill daily taken orally for one week
Korlym (mifepristone)	Korlym (mifepristone)	600 mg daily taken orally for one week

Primary Outcome Measures

Name	Time	Method
Craving to Drink	1 week	Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.

Secondary Outcome Measures

Name	Time	Method
Drinking	2 weeks	Number of standard drinks per week using the Timeline Followback Interview. Total number of alcoholic drinks consumed per week with a minimum value of 0 and a maximum value of 70.