Phase 2
N=16
INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02989662 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli — 0.267390; 0.040281; 0.058670; -0.069048 BOLD response
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mifepristone (Drug); Placebo - Cap (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Blood Oxygen Level Dependent (BOLD) fMRI Signal for Alcohol Versus Non-alcohol Stimuli |
0.267390; 0.040281; 0.058670; -0.069048; 0.037178; 0.052388 | — |
| SECONDARY Mean of Alcohol Motivated Responses Made |
9517 | — |
| SECONDARY Alcohol Motivated Responding - Number of Drinks Earned |
7 | — |
Summary
In alcohol use disorder (AUD) and matched healthy control (HC) men and women, the proposed research examines the effects of MIFE, with demonstrated preclinical effects on drinking-related behaviors, compared with placebo on a breadth of alcohol-related measures. All subjects will be randomized to daily MIFE or placebo. Before and during medication, AUD and HC subjects undergo fMRI scanning measuring resting-state functional connectivity and alcohol cue-induced brain activation focused on brain reward and stress pathways. All subjects are admitted to the Clinical Research Unit; AUD subjects undergo supervised alcohol withdrawal with daily measurements of alcohol craving and symptom severity. Using validated human laboratory procedures in AUD subjects, this study will examine the effects of stress on motivation to drink and alcohol sensitivity/reward as a function of GR antagonism.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02989662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.