Assessing the Pharmacokinetics and Drug Interaction Liability of Kratom, an Opioid-like Natural Product
Status:
Recruiting
Trial end date:
2021-08-31
Target enrollment:
Participant gender:
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.
Phase:
Early Phase 1
Details
Lead Sponsor:
Washington State University
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)