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NCT02187211 · ClinicalTrials.gov registry record · Phase 1
Minocycline's Effects on Alcohol Responses in Humans
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT02187211 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 54 participants.
The verdict
NCT02187211, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is a double-blind, placebo-controlled, outpatient study with a between-groups design. Sixty male and female heavy social drinkers will be randomly assigned to minocycline (200 or 400 mg/day) or placebo for 10 days. In the first 7 days of treatment, subjects will have 3 outpatient visits for medication administration, dispensing of take-home doses and monitoring of any adverse effects from study medications. On days 8 and 10 of treatment, subjects will have 2 laboratory sessions where alcohol or placebo will be administered intravenously using a clamp procedure. Alcohol administration will use a breath alcohol concentration (BrAc) method, targeting 100 mg %. The alcohol clamp procedure will allow collection of multiple outcome measures including subjective, motor, cognitive measurement and plasma cytokine levels.
Interventions
- DRUG Minocycline
- DRUG Placebo (for Minocycline)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2015-07-01 |
| Est. Completion | 2018-11-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02187211
The ClinicalTrials.gov registry entry for NCT02187211 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Minocycline is the first listed.
NCT02187211 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02187211 about?
NCT02187211 is a clinical study titled "Minocycline's Effects on Alcohol Responses in Humans". This is a double-blind, placebo-controlled, outpatient study with a between-groups design. Sixty male and female heavy social drinkers will be randomly assigned to minocycline (200 or 400 mg/day) or placebo for 10 days. In the first 7 days of treatment, subjects will have 3 outpatient visits for med...
What is the current status of trial NCT02187211?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2015-07-01. Estimated completion is 2018-11-01.
What interventions are being tested in trial NCT02187211?
The interventions under investigation include: Minocycline (DRUG), Placebo (for Minocycline) (DRUG).
Who is sponsoring clinical trial NCT02187211?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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