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Trial record 2 of 2 for:    mifepristone barbara mason
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Mifepristone Treatment of Alcohol Use Disorder

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: NCT02179749
Recruitment Status : Completed
First Posted : July 2, 2014
Results First Posted : October 6, 2022
Last Update Posted : October 6, 2022
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
The Scripps Research Institute

Study Description
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Brief Summary:
This is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups, study of 1-week of treatment with mifepristone (0, 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: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 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
Actual Primary Completion Date : November 2019
Actual Study Completion Date : November 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Drinking Quantity Per Day [ Time Frame: Participants will be followed for up to 12 weeks post-assignment ]

    Drinking quantity in standard drinks per day is measured by the Timeline Followback interview.

    A standard drink contains 14 grams of alcohol, e.g., 1.5 ounces of distilled spirits, 5 ounces of wine, or 12 ounces of beer.



Secondary Outcome Measures :
  1. Craving [ Time Frame: Participants will be followed for up to 12 weeks ]
    Alcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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): NCT02179749


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, Ph.D The Scripps Research Institute
  Study Documents (Full-Text)

Documents provided by The Scripps Research Institute:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol -IND  [PDF] July 2, 2014
Statistical Analysis Plan: Statistical Analysis Plan  [PDF] February 7, 2014
Informed Consent Form: Informed Consent  [PDF] April 12, 2019

More Information
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Responsible Party: The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT02179749    
Other Study ID Numbers: 1R01AA023152 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2014    Key Record Dates
Results First Posted: October 6, 2022
Last Update Posted: October 6, 2022
Last Verified: September 2022
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:
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Mifepristone
Disease
Alcoholism
Alcohol Drinking
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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