Mifepristone for the Prevention of Relapses of Alcohol Drinking

  • STATUS
    Recruiting
  • End date
    Dec 3, 2021
  • participants needed
    30
  • sponsor
    Brown University
Updated on 3 February 2021
Investigator
Zoe Brown, BS
Primary Contact
Center for Alcohol and Addiction Studies, Brown University (8.8 mi away) Contact

Summary

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

Details
Condition Alcohol abuse, Alcohol Use Disorder, Alcohol Use Disorders, Alcohol Dependence
Treatment Mifepristone 600-mg/day or placebo for a week
Clinical Study IdentifierNCT02243709
SponsorBrown University
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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