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OpenTrials
Completed

NCT Number: NCT01548417

Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Scripps Research Institute

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Korlym (mifepristone)

Drug

600 mg/day, oral pill, 7 days

Other names: Mifepristone, C-1073, Mifeprex, RU-486

Sugar pill

Drug

600 mg/day, oral pill, 7 days

Other names: Placebo

Primary outcomes

  1. Craving to Drink

    Time frame: 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 outcomes

  1. Drinking

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Scripps Research Institute

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 8, 2012
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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