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NCT07204171 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of Oral MG001
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Not yet
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT07204171 is a Phase 1 study that has not yet begun recruiting, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 32 participants.
The verdict
NCT07204171, a Phase 1 study, has not yet begun recruiting, sponsored by National Institute on Drug Abuse (NIDA).
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This research study is the first time the new medication MG001 is being tested in people. MG001 is a formulation of mitragynine, a compound that comes from a plant called Mitragyna speciosa (sometimes known as kratom), which some people use on their own to help manage symptoms of opioid withdrawal. The purpose of this study is to understand how safe MG001 is, how well it is tolerated, and how the body processes it. About 32 healthy adult volunteers, both men and women, will take part. Before joining, participants will undergo screening tests up to four weeks in advance to make sure they are eligible and healthy enough. On the day before dosing, participants will be admitted to the clinic for final health checks, and those who qualify will be randomly assigned-by chance, like flipping a coin-to receive either a single dose of MG001 or a placebo (an inactive substance). Neither the participants nor the staff giving the medicine will know which one is given. The study drug will be administered after at least 10 hours of fasting, and participants will then remain in the research clinic under close medical observation for three nights, until Day 4. During this time, doctors and nurses will monitor participants' health, look for any side effects, and collect blood samples to see how MG001 moves through the body. A follow-up clinic visit on Day 7 will provide one last check-in and blood test. This design helps researchers gather important first information on the safety and tolerability of MG001, while protecting the health and well-being of participants.
Interventions
- DRUG Placebo
- DRUG mitragynine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2026-09 |
| Est. Completion | 2027-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07204171
The ClinicalTrials.gov registry entry for NCT07204171 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07204171 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07204171 about?
NCT07204171 is a clinical study titled "Phase 1 Study of Oral MG001". This research study is the first time the new medication MG001 is being tested in people. MG001 is a formulation of mitragynine, a compound that comes from a plant called Mitragyna speciosa (sometimes known as kratom), which some people use on their own to help manage symptoms of opioid withdrawal. ...
What is the current status of trial NCT07204171?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2026-09. Estimated completion is 2027-04.
What interventions are being tested in trial NCT07204171?
The interventions under investigation include: Placebo (DRUG), mitragynine (DRUG).
Who is sponsoring clinical trial NCT07204171?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
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