Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

The Scripps Research Institute

Status and phase

Completed

Phase 2

Conditions

Alcoholism

Treatments

Drug: Sugar Pill

Drug: Korlym (mifepristone)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01548417

2R01AA012602-11A1 (U.S. NIH Grant/Contract)

AA012602-11A1

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.