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Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01548417
Recruitment Status : Completed
First Posted : March 8, 2012
Results First Posted : May 19, 2016
Last Update Posted : June 24, 2016
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Korlym (mifepristone) Drug: Sugar Pill Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists
Study Start Date : March 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Korlym (mifepristone)
600 mg daily taken orally for one week
 Drug: Korlym (mifepristone)
600 mg/day, oral pill, 7 days
Other Names:
  • Mifepristone
  • C-1073
  • Mifeprex
  • RU-486
Placebo Comparator: Sugar Pill
placebo pill daily taken orally for one week
 Drug: Sugar Pill
600 mg/day, oral pill, 7 days
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548417


Locations
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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)
Investigators
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Principal Investigator: Barbara J Mason, PhD The Scripps Research Institute
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Barbara J. Mason, PI, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT01548417    
Other Study ID Numbers: AA012602-11A1
2R01AA012602-11A1 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2012    Key Record Dates
Results First Posted: May 19, 2016
Last Update Posted: June 24, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Barbara J. Mason, The Scripps Research Institute:
Alcohol
Relapse
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
 Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Hormonal
Menstruation-Inducing Agents