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NCT04392011 · ClinicalTrials.gov registry record · Early Phase 1
Assessing the Pharmacokinetics and Drug Interaction Liability of Kratom, an Opioid-like Natural Product
A Early Phase 1 study, sponsored by Washington State University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
NCT04392011: Completed Early Phase 1 study, sponsored by Washington State University.
NCT04392011 is a Early Phase 1 study that has completed, run by Washington State University. The registered enrollment target is 15 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04392011, a Early Phase 1 study, has completed, sponsored by Washington State University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Kratom is a botanical natural product that has opioid-like effects. Kratom is commonly used to self-treat withdrawal symptoms associated with opioid addiction, as well as pain. Kratom products include pills, extracts, and powders, most of which contain two primary psychoactive constituents: mitragynine and 7-hydroxymitragynine. Preliminary data from the investigator's laboratory has shown that these two constituents and extracts made from commercially available kratom products are strong inhibitors of the drug metabolizing enzymes cytochrome P450 (CYP) 2D6 and CYP3A4. These enzymes are responsible for metabolizing more than 50% of marketed drugs, including several opioids, benzodiazepines, and antidepressants. Thus, co-consumption of kratom products with drugs metabolized by CYP2D6 and CYP3A4 could increase the risk of serious adverse effects. The effects of a well-characterized kratom product on CYP2D6 and CYP3A4 activity will be assessed in healthy volunteers using a 'cocktail' approach consisting of the validated probe drugs dextromethorphan and midazolam. Results will (1) provide useful information regarding risks associated with co-consuming kratom with opioids and other CYP2D6 and CYP3A4 drug substrates and (2) inform the design of future kratom-drug interactions studies.
Primary Outcome
Area under the plasma concentration time curve (AUC) of midazolam
Interventions
- DIETARY_SUPPLEMENT Kratom
- DRUG Midazolam HCl
- DRUG Dextromethorphan HBr
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2021-08-31 |
| Phase | Early Phase 1 |
What the finished NCT04392011 record still lists
NCT04392011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Kratom is the first listed.
NCT04392011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04392011 about?
NCT04392011 is a clinical study titled "Assessing the Pharmacokinetics and Drug Interaction Liability of Kratom, an Opioid-like Natural Product". Kratom is a botanical natural product that has opioid-like effects. Kratom is commonly used to self-treat withdrawal symptoms associated with opioid addiction, as well as pain. Kratom products include pills, extracts, and powders, most of which contain two primary psychoactive constituents: mitragyn...
What is the current status of trial NCT04392011?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2019-10-09. Estimated completion is 2021-08-31.
What interventions are being tested in trial NCT04392011?
The interventions under investigation include: Kratom (DIETARY_SUPPLEMENT), Midazolam HCl (DRUG), Dextromethorphan HBr (DRUG).
Who is sponsoring clinical trial NCT04392011?
This trial is sponsored by Washington State University, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04392011's enrollment target sits among peer trials
15 1404th of 2000 higher than 527 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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