INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers
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ClinicalTrials.gov Identifier: NCT02989662 |
Recruitment Status :
Recruiting
First Posted : December 12, 2016
Last Update Posted : August 11, 2021
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Condition or disease | Intervention/treatment | Phase |
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Alcohol Use Disorder | Drug: Mifepristone Drug: Placebo - Cap | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Glucocorticoid Antagonists in Heavy Drinkers: Effects on fMRI Connectivity, Withdrawal and Drinking |
Study Start Date : | February 2016 |
Estimated Primary Completion Date : | January 2023 |
Estimated Study Completion Date : | January 2023 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Mifepristone
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.
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Drug: Mifepristone
Participants receive 6 doses.
Other Name: Korlym |
Placebo Comparator: Placebo - Cap
This is an inactive compound which appears physically identical to active medication.
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Drug: Placebo - Cap
Participants receive 6 doses |
- fMRI function connectivity [ Time Frame: Change from baseline to day 4 of MIFE dosing ]fMRI data including resting state and alcohol cue induced measures
- Alcohol motivated responding [ Time Frame: single session on study day 5 ]Participants can earn up to 5 standard drinks during a 1-hr session.
- Alcohol sensitivity [ Time Frame: single session on study day 6 ]Subjective and physiological effects of alcohol are measured repeatedly during a 4-hr session

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Nontreatment seeking AUD volunteers
- English speaking
- healthy
- Not pregnant or nursing
Exclusion Criteria:
- Women on hormonal birth control, pregnant or nursing
- Current health or psychiatric problems
- Potassium level below normal
- Any medication or health condition that is known to interact with MIFE or CORT metabolism
- History of metal implantation that would preclude MRI scan.

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): NCT02989662
Contact: Mary E McCaul, PhD | 410-955-9526 | mmccaul1@jhmi.edu | |
Contact: Gary S Wand, MD | 410-955-3921 | gwand1@jhmi.edu |
United States, Maryland | |
Integrated Program for Substance Abuse Research | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Mary E McCaul, PhD 410-955-9526 mmccaul1@jhmi.edu | |
Contact: JoAnna Mathena, MS 410-955-9524 jmathen5@jhmi.edu |
Principal Investigator: | Mary E McCaul, PhD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT02989662 |
Other Study ID Numbers: |
IRB00138426 U01AA020890 ( U.S. NIH Grant/Contract ) AA020890 ( Other Identifier: Other ) |
First Posted: | December 12, 2016 Key Record Dates |
Last Update Posted: | August 11, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Mifepristone Alcoholism Alcoholic Intoxication Alcohol-Related Disorders 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 Contraceptive Agents, Hormonal Menstruation-Inducing Agents |