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NCT02989662 · ClinicalTrials.gov registry record · Phase 1
INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT02989662: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT02989662 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 65 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02989662, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study 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.
Interventions
- DRUG Mifepristone
- DRUG Placebo - Cap
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2017-09-26 |
| Est. Completion | 2024-01-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02989662
The ClinicalTrials.gov registry entry for NCT02989662 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mifepristone is the first listed.
NCT02989662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02989662 about?
NCT02989662 is a clinical study titled "INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers". 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 da...
What is the current status of trial NCT02989662?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2017-09-26. Estimated completion is 2024-01-31.
What interventions are being tested in trial NCT02989662?
The interventions under investigation include: Mifepristone (DRUG), Placebo - Cap (DRUG).
Who is sponsoring clinical trial NCT02989662?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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