Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

Study Overview
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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.

Official Title
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Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

Conditions
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Alcoholism

Intervention / Treatment
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* Drug: Korlym (mifepristone)
* Drug: Sugar Pill


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 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.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Korlym (mifepristone)<br>600 mg daily taken orally for one week | Drug: Korlym (mifepristone)<br>* 600 mg/day, oral pill, 7 days<br>* Other names: RU-486;|
| Placebo Comparator: Sugar Pill<br>placebo pill daily taken orally for one week | Drug: Sugar Pill<br>* 600 mg/day, oral pill, 7 days<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving to Drink | 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinking | 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol, Relapse