INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT02989662

Run by

Johns Hopkins University

People needed

65

Starts

2017-09-26

Expected to finish

2024-01-31

Last updated by the study team

2025-05-30

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Nontreatment seeking AUD volunteers
• English speaking
• healthy
• Not pregnant or nursing

You may not qualify if…

• 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.

Where it is running

• Integrated Program for Substance Abuse Research — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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