Alcohol Use Disorders (AUD)Phase 1/2NCT02243709

Mifepristone for the Prevention of Relapses of Alcohol Drinking

A Phase 1/2 study of Alcohol Use Disorders (AUD), run by Brown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Alcohol Use Disorders (AUD)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited States
Study dates: Sep 2014to 21 Dec 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 24Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: 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

Conditions: Alcohol Use Disorders (AUD)
Being tested: Mifepristone 600-mg/day or placebo for a week
Keywords: Stress, alcohol craving, alcohol use disorders
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mifepristone 600-mg/day or placebo for a weekDrug
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

Study groups in NCT02243709
Study group	Role	What they receive
Mifepristone	Active comparator	mifepristone 600-mg/day for a week, in a stress-induced condition triggered by a single dose of 32.4-mg of yohimbine Receives: Drug: Mifepristone 600-mg/day or placebo for a week
Sugar pill	Placebo comparator	matching placebo/day for a week, in a stress-induced condition triggered by a single dose of 32.4-mg of yohimbine Receives: Drug: Mifepristone 600-mg/day or placebo for a week

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Experiencing Adverse Events in the Mifepristone Versus Placebo Group as a Measure of Safety and Tolerability
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.
Measured: 5 weeks (one week of drug administration, 3 weeks of washout, followed by one week of drug administration)

Secondary outcomes (2)

Alcohol Craving Score on the Alcohol Craving Questionnaire in the Mifepristone Versus Placebo Group
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.
Measured: 1 day
Drinking Consumption in the Mifepristone Verses Placebo Group
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.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201421 Dec 2021

First posted18 Sep 2014 (estimated)
Study startSep 2014
Primary completion21 Dec 2021
Study completion21 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Alcohol Use Disorders (AUD)Studies of the same condition, open and under way.
More trials run by Brown UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02243709
Sponsor's protocol ID: 1404001031
Status last verified: Dec 2024
First submitted: 12 Sep 2014
Last updated: 10 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Simms JA, Haass-Koffler CL, Bito-Onon J, Li R, Bartlett SE. Mifepristone in the central nucleus of the amygdala reduces yohimbine stress-induced reinstatement of ethanol-seeking. Neuropsychopharmacology. 2012 Mar;37(4):906-18. doi: 10.1038/npp.2011.268. Epub 2011 Nov 2.
PubMed 22048462
Haass-Koffler CL, Magill M, Cannella N, Brown JC, Aoun EG, Cioe PA, Sinha R, Swift RM, Ciccocioppo R, Leggio L. Mifepristone as a pharmacological intervention for stress-induced alcohol craving: A human laboratory study. Addict Biol. 2023 Jul;28(7):e13288. doi: 10.1111/adb.13288.
PubMed 37369125
Haass-Koffler CL, Magill M, Cannella N, Brown JC, Aoun EG, Cioe PA, Sinha R, Swift RM, Ciccocioppo R, Leggio L. Mifepristone as a pharmacological intervention for stress-Induced alcohol craving: a translational crossover randomized trial. medRxiv [Preprint]. 2023 Jan 4:2023.01.02.23284122. doi: 10.1101/2023.01.02.23284122.
PubMed 36711869

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study on the Safety and Efficacy of Mifepristone for the Prevention of Relapses of Alcohol Drinking
ClinicalTrials.gov ID: NCT02243709
Acronym / sponsor ID: 1404001031
Conditions: Alcohol Use Disorders (AUD)
Keywords: Stress, alcohol craving, alcohol use disorders
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Brown UniversityUniversity, hospital or other
Study start: Sep 2014 (actual)
Primary completion: 21 Dec 2021 (actual)
Study completion: 21 Dec 2021 (actual)
First posted: 18 Sep 2014 (estimated)
Results: Posted 1 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mifepristone	Active comparator	Drug: Mifepristone 600-mg/day or placebo for a weekmifepristone 600-mg/day for a week, in a stress-induced condition triggered by a single dose of 32.4-mg of yohimbine
Sugar pill	Placebo comparator	Drug: Mifepristone 600-mg/day or placebo for a weekmatching placebo/day for a week, in a stress-induced condition triggered by a single dose of 32.4-mg of yohimbine

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (24 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mifepristone 600-mg/day or placebo for a week600-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	Drug	Mifepristone, Sugar pill

Primary outcome

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.

2 secondary outcomes

Alcohol Craving Score on the Alcohol Craving Questionnaire in the Mifepristone Versus Placebo Group
Time frame: 1 day
Drinking Consumption in the Mifepristone Verses Placebo Group
Time frame: 1 day

Results and safety

Results posted to the registry on 1 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mifepristone, Then Placebo	12	11
Placebo, Then Mifepristone	20	17

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Mifepristone n = 27	Placebo n = 31
Value	0	3

Mifepristone vs Placebo: p >.05, Chi-squared

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were monitored for 5 weeks (one week of medication administration, followed by a three week wash out period, then followed by another week of medication administration). Medication administration is randomized between subjects within a cross over design.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mifepristone	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Placebo	0 of 31 (0%)	3 of 31 (9.7%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22048462Simms JA, Haass-Koffler CL, Bito-Onon J, Li R, Bartlett SE. Mifepristone in the central nucleus of the amygdala reduces yohimbine stress-induced reinstatement of ethanol-seeking. Neuropsychopharmacology. 2012 Mar;37(4):906-18. doi: 10.1038/npp.2011.268. Epub 2011 Nov 2.
Results publication: PubMed 37369125Haass-Koffler CL, Magill M, Cannella N, Brown JC, Aoun EG, Cioe PA, Sinha R, Swift RM, Ciccocioppo R, Leggio L. Mifepristone as a pharmacological intervention for stress-induced alcohol craving: A human laboratory study. Addict Biol. 2023 Jul;28(7):e13288. doi: 10.1111/adb.13288.
Derived from this study: PubMed 36711869Haass-Koffler CL, Magill M, Cannella N, Brown JC, Aoun EG, Cioe PA, Sinha R, Swift RM, Ciccocioppo R, Leggio L. Mifepristone as a pharmacological intervention for stress-Induced alcohol craving: a translational crossover randomized trial. medRxiv [Preprint]. 2023 Jan 4:2023.01.02.23284122. doi: 10.1101/2023.01.02.23284122.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carolina L Haass-Koffler, PharmD principal investigator

Brown University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study of Alcohol Use Disorders (AUD), run by Brown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02243709, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.