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Trial record 1 of 1 for:    Mifepristone + Standardized behavioral therapy - Ethanol dependence
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Mifepristone Treatment of Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT02179749
Recruitment Status : Recruiting
First Posted : July 2, 2014
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
The Scripps Research Institute

Brief Summary:
This is an 8-week, randomized, double-blind, placebo-controlled, 3 arm, parallel groups, dose-ranging study of 1-week of treatment with mifepristone (0, 600, 1200 mg/d) given in conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Alcohol Use Disorders Alcohol Abuse Alcoholism Drug: Mifepristone 1200 mg daily Behavioral: Standardized behavioral therapy Drug: Mifepristone 600 mg daily Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Glucocorticoid Antagonist Treatment of Alcohol Use Disorder
Study Start Date : September 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: Experimental: mifepristone 600 mg daily
600 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Behavioral: Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 8 week duration.
Other Name: Manually-guided therapy

Drug: Mifepristone 600 mg daily
Mifepristone, 300 mg tablets, Two tablets daily/am plus two placebo tablets daily/am for 1-week duration.
Other Name: Korlym

Active Comparator: Experimental: mifepristone 1200 mg daily
1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Drug: Mifepristone 1200 mg daily
Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.
Other Name: Korlym

Behavioral: Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 8 week duration.
Other Name: Manually-guided therapy

Placebo Comparator: Placebo daily, 1-week
Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Behavioral: Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 8 week duration.
Other Name: Manually-guided therapy

Drug: Placebo
Placebo tablets, Four tablets daily/am for 1-week duration.
Other Name: Placebo Comparator




Primary Outcome Measures :
  1. Drinking [ Time Frame: Participants will be followed for up to 8 weeks ]
    Drinking quantity


Secondary Outcome Measures :
  1. Craving [ Time Frame: Participants will be followed for up to 8 weeks ]
    Alcohol Craving Questionnaire



Information from the National Library of Medicine

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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 (DSM)-V criteria for current alcohol use disorder of moderate or greater severity, defined by DSM-V as ≥ 4 symptoms
  • Abstinent a minimum of 3 days (but not more than 30 days) prior to randomization
  • In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, ECG, urine test and lab tests
  • Females with childbearing potential must have a negative serum pregnancy test on the screening visit and a negative urine pregnancy test at randomization and agree to use non-hormonal effective birth control for the study duration and one month thereafter

Exclusion Criteria:

  • A medical condition or chronic use of a medication that contraindicates the administration of mifepristone
  • Significant medical disorders or clinically significant findings on ECG (e.g., prolongation of the corrected QT interval,urine or blood tests that increase potential risk or interfere with study participation as determined by the Study Physician. Note: serum potassium below the normal range must be replaced to normal prior to randomization; individuals with serum potassium outside the range of normal will not be randomized
  • Liver function tests more than 3 times the upper limit of normal or elevated bilirubin
  • Female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective non hormonal birth control for the 1-week of medication administration and one month thereafter
  • Meets Diagnostic and Statistical Manual -V criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders other than alcohol or nicotine use disorders

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): NCT02179749


Contacts
Contact: Susan Quello, B.A. B.S 858-784-7327 squello@scripps.edu

Locations
United States, California
The Scripps Research Institute Recruiting
La Jolla, California, United States, 92037
Contact: Susan Quello, B.A. B.S.    858-784-7327    squello@scripps.edu   
Principal Investigator: Barbara J. Mason, Ph.D         
Sponsors and Collaborators
The Scripps Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Barbara J. Mason, Ph.D The Scripps Research Institute

Responsible Party: The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT02179749     History of Changes
Other Study ID Numbers: 1R01AA023152 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Scripps Research Institute:
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Mifepristone
Glucocorticoid Antagonists
Alcohol Treatment
Alcohol

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Ethanol
Mifepristone
Disease
Alcoholism
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Glucocorticoids
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents