Phase 1 Study of Oral MG001 for Safety and Tolerability

This study is testing a new medication called MG001, which is a form of mitragynine (from the kratom plant). It's the first time MG001 is being given to people. The main goal is to see how safe MG001 is, how well people tolerate it, and how the body handles it. About 32 healthy adults, aged 18 to 65, can join. You must have used prescription or recreational oral opioids at least once in the past 30 days. Participants will receive either MG001 or a placebo (an inactive substance). The study will measure any side effects that happen during the study period, which includes 4 days in the clinic and a follow-up visit on day 7. The current recruitment status is unclear.

Study design: This is a Phase 1, randomized, double-blind, placebo-controlled study involving about 32 healthy participants. Participants will be randomly assigned to receive either MG001 or a placebo.
What's involved: You would undergo screening tests up to four weeks before the study, stay in a clinic for 4 days, and have a follow-up visit on day 7.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for safety and other assessments until discharge on Day 4, with a final follow-up visit on Day 7.

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Phase 1 Study of Oral MG001

Not Yet Recruiting

PHASE1Ages 18–65InterventionalTreatment

National Institute on Drug Abuse (NIDA)

~32 participants

Updated 2026-06-16 on ClinicalTrials.gov

What's tested:mitragyninePlacebo

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence of Treatment-Emergent Adverse Events in Healthy Adult Participants

Measured over 4 days in clinic, follow-up on day 7

Conditions

Safety and Tolerability in Healthy Subjects

Where it's being run

1 sites across 1 states

Kansas1

Study leadership

Julia Solarczyk Donnelly, MS, RAC · STUDY_DIRECTOR · National Institute on Drug Abuse, NIH

Who to contact

Debra Kelsh, MD

[email protected]

913-696-1601

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Any lifetime history of serious or recurrent suicidal behavior.

Previous history of suicidal behaviors in the past 10 years.

Suicidal ideation with or without a plan (active or passive, respectively) in the past year. 4. Has a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia; or any other conditions that increase seizure risk in the opinion of the study clinician. 5. Has a history of thyroid and/or parathyroid disease or abnormal T4 or PTH levels. 6. Has evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening ECG that, in the opinion of the study medical clinician, would preclude safe participation in the study. 7. Has any clinically significant abnormal laboratory values 8. Has taken kratom or any investigational drug in another study within 30 days of study consent. 9. Requires treatment with opioid-containing medications (e.g., opioid analgesics) during the study period. 10. Has used opioids intravenously or on 3 or more consecutive days during the 30 day period preceding screening. 11. Has a sitting systolic blood pressure (SBP) \>140 mmHg, diastolic BP (DBP) \>90 mmHg or HR \<50 or \>100 beats per minute (BPM) at screening and clinic intake. 12. Has orthostatic hypotension, defined as a 20 mmHg reduction in SBP and 10 mmHg in DBP. 13. Has an O2 saturation, defined as the percentage of hemoglobin in the blood that is carrying oxygen, below 95% from a 10 second reading. 14. Has donated blood (excluding plasma donation) of approximately 500 mL within 56 days prior to screening. 15. Has donated plasma within 7 days prior to screening. 16. Has taken any concomitant medications, including prescription, over-the-counter, dietary supplements, herbal products, vitamins, or medications interacting with CYP3A4, CYP2D6, or CYP1A2 within 14 days or 5-half-lives (whichever is longer) prior to study drug administration, and throughout the study.

What this trial measures

Incidence of Treatment-Emergent Adverse Events in Healthy Adult Participants4 days in clinic, follow-up on day 7
The incidence of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment. The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship to the treatment and maximum severity. Events will be identified either through subject self-report or clinically significant abnormal findings on: (i) Physical examination (ii) Vital signs assessments (heart rate (BPM), blood pressure (mmHg), respiration rate (BPM), hemoglobin saturation (%) and temperature (F)) (iii) ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist (iv) pupil constriction (mm) (v) sedation as measured by VAS (score) and MOAA/S (score (vi) Clinical Laboratory Assessments

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