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Trial record 1 of 1 for:    Prevention of Relapses of Alcohol Drinking Mifepristone
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Mifepristone for the Prevention of Relapses of Alcohol Drinking

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ClinicalTrials.gov Identifier: NCT02243709
Recruitment Status : Recruiting
First Posted : September 18, 2014
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Carolina Haass-Koffler, Brown University

Brief Summary:
The goal of this study is to determine if, under stress, alcohol drinking is reduced using mifepristone

Condition or disease Intervention/treatment Phase
Alcohol Use Disorders (AUD) Drug: Mifepristone 600-mg/day or placebo for a week Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Pilot Study on the Safety and Efficacy of Mifepristone for the Prevention of Relapses of Alcohol Drinking
Actual Study Start Date : September 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: Mifepristone
mifepristone 600-mg/day for a week, in a stress-induced condition triggered by a single dose of 32.4-mg of yohimbine
Drug: Mifepristone 600-mg/day or placebo for a week
600-mg of mifepristone for a week, compared to placebo for a week, in a stress-induced condition triggered by a single dose of 32.4 mg of yohimbine

Placebo Comparator: Sugar pill
matching placebo/day for a week, in a stress-induced condition triggered by a single dose of 32.4-mg of yohimbine
Drug: Mifepristone 600-mg/day or placebo for a week
600-mg of mifepristone for a week, compared to placebo for a week, in a stress-induced condition triggered by a single dose of 32.4 mg of yohimbine




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 11-weeks ]

Secondary Outcome Measures :
  1. Alcohol craving score on the Alcohol Craving Questionnaire [ Time Frame: 11-weeks ]
  2. Drinking consumption [ Time Frame: 11-weeks ]
    Number of drinks during alcohol session



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

Inclusion Criteria:

  • Male or female, 21 to 65 years of age
  • Females must be postmenopausal for at least one year or surgically sterile (proven by medical record)
  • Meet criteria for Alcohol Use Disorders (AUD) DSM-5 diagnosis
  • Meet drinking criteria (≥3 drinks/day for men; ≥2 drinks /day for women)
  • Must be in good health as confirmed by medical history, physical examination, ECG, lab tests
  • Participants must be willing to take oral medication and adhere to the study procedures
  • Breath alcohol (BrAC) = 0.00 at each visit
  • Be able to understand informed consent and questionnaire in English at an 8th grade level

Exclusion Criteria:

  • Individuals expressing interest in treatment for alcoholism
  • Premenopausal women
  • Participants who have significant alcohol withdrawal symptoms, defined as a CIWA-Ar score ≥7
  • A repeated positive urine drug screen at baseline for any illegal substance except marijuana.
  • Individuals diagnosed with a current "severe" Substance Use Disorder (SUD) diagnosis, other than alcohol or nicotine
  • Meet DSM-5 criteria for a diagnosis of schizophrenia, bipolar disorder, or other psychoses
  • An active illness within the past six months of the screening visit that meets the DSM-5 criteria for a diagnosis of Major Depressive Disorder (MDD) or Anxiety Disorder, or history of attempted suicide
  • Clinically significant medical abnormalities: unstable hypertension, clinically significant abnormal ECG, bilirubin >150% of the upper normal limit, ALT/AST >300% the UNL, creatinine clearance ≤60 dl/min
  • Current use of psychotropic medications that may have an effect on alcohol consumption
  • Current use of any medication involved in the metabolism of alcohol such as aldehyde dehydrogenase (ALDH), alcohol dehydrogenase (ADH) and CYP2E1: Cefamandole, Cefotetan, Sulfamethoxazole, Nitroglycerin, Chlorpropamide, Glyburide.
  • Current use of any medication (CYP3A4 inhibitor and substrate) that may interact with mifepristone: cyclosporine, fentanyl, heparin, escitalopram, lovastatin, simvastatin, warfarin
  • Current use of any medication (CYP2D6 inhibitor and substrate) that may interact with yohimbine: amitriptyline, doxepin, nortriptyline, venlafaxine
  • Medical contraindications for use of mifepristone or yohimbine
  • A history of adverse reaction or hypersensitivity to mifepristone or yohimbine
  • History of suicide
  • History of seizure disorders
  • Hypokalemia (low potassium level)<3.5mEq/L
  • Participated in any behavioral and/or pharmacological study within minimum the past 30 days
  • Neuroendocrine disorders
  • Taking corticosteroids
  • Bleeding disorders
  • Pre-existing QT prolongation on ECG
  • History of porphyria (Mifepristone progesterone receptor antagonist is an inducer of CYP-450 and therefore may have the ability to precipitate or exacerbate attacks of acute porphyria)
  • Not willing to engage in protected sex (condom). This risk includes both women and men. Mifepristone long half-life (t1/2 = 18 hrs) and its three main metabolites retain considerable affinity toward human progesterone and glucocorticoid receptors, with serum level similar to the parent mifepristone and there are no studies on the presence of mifepristone or metabolites in semen

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): NCT02243709


Contacts
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Contact: Zoe Brown, BS 401-863-6646 zoe_brown@brown.edu

Locations
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United States, Rhode Island
Center for Alcohol and Addiction Studies, Brown University Recruiting
Providence, Rhode Island, United States, 02912
Contact: Victoria Long, BS    401-863-6646    alcohol.stress.study@gmail.com   
Principal Investigator: Carolina L Haass-Koffler, PharmD         
Sub-Investigator: Robert M Swift, MD, PhD         
Sponsors and Collaborators
Brown University
Investigators
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Principal Investigator: Carolina L Haass-Koffler, PharmD Brown University
Publications:
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Responsible Party: Carolina Haass-Koffler, Research Fellow, Brown University
ClinicalTrials.gov Identifier: NCT02243709    
Other Study ID Numbers: 1404001031
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Keywords provided by Carolina Haass-Koffler, Brown University:
Stress, alcohol craving, alcohol use disorders
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Mifepristone
Alcoholism
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
Menstruation-Inducing Agents