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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 is a Early Phase 1 study that has completed, run by Washington State University. The registered enrollment target is 15 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04392011
The ClinicalTrials.gov registry entry for NCT04392011 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington State University, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Kratom is the first listed.
NCT04392011 reports 0 study locations.
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.
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