Mifepristone for the Prevention of Relapses of Alcohol Drinking

May 4, 2023 updated by: Carolina Haass-Koffler, Brown University

A Pilot Study on the Safety and Efficacy of Mifepristone for the Prevention of Relapses of Alcohol Drinking

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Center for Alcohol and Addiction Studies, Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Adverse Events in the Mifepristone Versus Placebo Group as a Measure of Safety and Tolerability
Time Frame: 5 weeks (one week of drug administration, 3 weeks of washout, followed by one week of drug administration)
Safety and tolerability was assessed by the number of participants who experienced adverse events (AEs) while taking the medication, in the mifepristone group verses the placebo group during Visit 2 through and until Visit 5. AEs were assessed at each visit and special attention was paid to any AEs experienced after administration of the oral administration of mifepristone or placebo- Visit 2 to Visit 3 (7 days total) and Visit 4 through Visit 5 (7 days total), and when it was administered with alcohol during the laboratory paradigms at visits 3 and 4.
5 weeks (one week of drug administration, 3 weeks of washout, followed by one week of drug administration)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Craving Score on the Alcohol Craving Questionnaire in the Mifepristone Versus Placebo Group
Time Frame: 1 day
Alcohol craving will be assessed by the Alcohol Craving Questionnaire Short Form - Revised (ACQ-SF-R). The ACQ-SF-R is a 12-item self-report scale that contains items from the 47-item Alcohol Craving Questionnaire (ACQ-Now). ACQ-SF-R also produces scores for compulsivity, expectancy, purposefulness, and emotionality. To assess this outcome, at the alcohol cue reactivity procedures/visits 3 and 5 during alcohol trial 1, the 12-item total ACQ will be summed for each participant and then the total score will be averaged for a mean score. The average ACQ score in the presence of alcohol cues will be compared when participants are taking mifepristone compared to placebo. The ACQ has a total score range between 0-84. A lower score indicates less subjective alcohol craving.
1 day
Drinking Consumption in the Mifepristone Verses Placebo Group
Time Frame: 1 day
Number of standard drinks desired to be consumed by participants during mifepristone administration compared to placebo administration during the open bar (free choice procedure) in the alcohol cue reactivity at visits 3 and 5.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Investigators

  • Principal Investigator: Carolina L Haass-Koffler, PHARMD, Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

December 21, 2021

Study Completion (Actual)

December 21, 2021

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimated)

September 18, 2014

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404001031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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