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Corticosteroid

Mifepristone for Alcohol Use Disorder

N/A
Waitlist Available
Led By Mary E McCaul, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up single session on study day 6
Awards & highlights

Study Summary

This trial looks at the effects of a new medication, MIFE, on people with alcohol use disorder compared to a placebo group. They will use fMRI scans to look at how different areas of the brain are affected by alcohol cues, and also look at how well the medication works in reducing cravings and sensitivity to alcohol.

Who is the study for?
This trial is for English-speaking men and women who are heavy drinkers but not currently seeking treatment. They must be generally healthy and not pregnant or nursing. People can't join if they're on medications that interact with Mifepristone, have certain health or psychiatric conditions, low potassium levels, or metal implants incompatible with MRI scans.Check my eligibility
What is being tested?
The study tests the effects of a drug called Mifepristone against a placebo in reducing alcohol-related behaviors in heavy drinkers. Participants will undergo brain scans before and during the medication period to see how it affects their brain's response to alcohol cues and stress pathways.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants should be aware that Mifepristone could potentially affect mood, hormone levels, menstrual cycle in women, blood sugar control, and might cause fatigue or stomach discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~single session on study day 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and single session on study day 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
fMRI function connectivity
Secondary outcome measures
Alcohol motivated responding
Alcohol sensitivity

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MifepristoneActive Control1 Intervention
Mifepristone is a high affinity antagonist of the glucocorticoid receptor (GR). It is FDA approved to treatment hyperglycemia caused by high cortisol levels in adults with endogenous Cushing's syndrome.
Group II: Placebo - CapPlacebo Group1 Intervention
This is an inactive compound which appears physically identical to active medication.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,259 Previous Clinical Trials
14,820,588 Total Patients Enrolled
14 Trials studying Alcoholism
1,962 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
799 Previous Clinical Trials
1,362,446 Total Patients Enrolled
422 Trials studying Alcoholism
985,143 Patients Enrolled for Alcoholism
Mary E McCaul, PhDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Alcoholism
200 Patients Enrolled for Alcoholism

Media Library

Mifepristone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02989662 — N/A
Alcoholism Research Study Groups: Mifepristone, Placebo - Cap
Alcoholism Clinical Trial 2023: Mifepristone Highlights & Side Effects. Trial Name: NCT02989662 — N/A
Mifepristone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02989662 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this trial confined to participants over the age of 20?

"As stated in the recruitment criteria for this medical experiment, potential participants must be between 21 and 55 years old."

Answered by AI

Could you elaborate on prior research done concerning Mifepristone?

"Currently, there are 9 medical trials underway that involve the use of Mifepristone with 2 being in their final phase. While New york City is leading the charge, a total of 31 clinical sites have opened to conduct research on this compound."

Answered by AI

Is this experiment actively enlisting participants?

"Per the clinicaltrials.gov listing, this experiment is currently recruiting subjects. The trial was initially published on February 1st 2016, and its details were most recently revised on August 9th 2022."

Answered by AI

To what extent has the patient cohort grown for this experiment?

"Affirmative. In accordance with the clinicaltrials.gov database, this research project is actively seeking participants for enrollment. Initially posted on February 1st 2016 and subsequently edited in August 2022, the trial aims to enrol 150 patients from a single medical centre."

Answered by AI

To what purpose is Mifepristone typically applied?

"Mifepristone is a recommended treatment for medical procedures, hyperglycemia, and induced abortions."

Answered by AI

What are the criteria for people to qualify as volunteers in this clinical experiment?

"This trial seeks approximately 150 people who are between the legal drinking age and 55, and suffer from alcohol intoxication."

Answered by AI

Who else is applying?

What site did they apply to?
Integrated Program for Substance Abuse Research
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers
2016. "INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02989662.
~7 spots leftby Apr 2025
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