Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

This study has been completed.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute Identifier:
First received: March 5, 2012
Last updated: October 29, 2015
Last verified: October 2015
The primary hypotheses under test are that alcohol dependent subjects treated with mifepristone will report decreased craving for alcohol following cue- and stress induced exposure in the laboratory and report fewer symptoms of protracted abstinence (e.g., craving, anxiety, mood and sleep disturbances) under naturalistic conditions, significantly more than those treated with placebo.

Condition Intervention Phase
Drug: Korlym (mifepristone)
Drug: Sugar Pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

Resource links provided by NLM:

Further study details as provided by The Scripps Research Institute:

Primary Outcome Measures:
  • Craving to Drink [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues.

Secondary Outcome Measures:
  • Drinking [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Number of standard drinks per week using the Timeline Followback Interview

Enrollment: 56
Study Start Date: March 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Korlym (mifepristone) Drug: Korlym (mifepristone)
600 mg/day, oral pill, 7 days
Other Names:
  • Mifepristone
  • C-1073
  • Mifeprex
  • RU-486
Placebo Comparator: Sugar Pill Drug: Sugar Pill
600 mg/day, oral pill, 7 days


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female volunteers, 18-65 years of age
  • Meets 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 BAC and a CIWA 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.
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Please refer to this study by its identifier: NCT01548417

United States, California
The Scripps Research Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
The Scripps Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Barbara J Mason, PhD The Scripps Research Institute
  More Information

Additional Information:
No publications provided by The Scripps Research Institute

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Barbara J. Mason, PI, The Scripps Research Institute Identifier: NCT01548417     History of Changes
Other Study ID Numbers: AA012602-11A1  2R01AA012602-11A1 
Study First Received: March 5, 2012
Last Updated: October 29, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The Scripps Research Institute:

Additional relevant MeSH terms:
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Abortifacient Agents
Abortifacient Agents, Steroidal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital
Contraceptives, Postcoital, Synthetic
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on February 04, 2016