Evaluating How Kratom Affects Oxycodone Processing and Effects Study of Potential Kratom-Oxycodone Interaction with Clinical Measures

What this Trial Is About

Researchers are investigating how the botanical product kratom influences the way the body processes the opioid drug oxycodone and whether kratom changes oxycodone's effects on the body. This early phase 1 study focuses on both the pharmacokinetic interaction, meaning how oxycodone is broken down and removed from the body, and the pharmacodynamic interaction, by measuring pupil diameter as a sensitive indicator of opioid effects on the central nervous system. Healthy adults aged 21 to 45 are participating to provide insight into these interactions. Participants will complete four study arms involving different combinations of kratom and oxycodone administration. These include a single dose of kratom tea, a single oral dose of immediate-release oxycodone tablet, both kratom tea and oxycodone given together, and kratom tea taken daily at home for four days followed by kratom tea and oxycodone given together in the research setting. The kratom tea is made by stirring 2 grams of dry leaf powder in hot water and cooled before drinking. During the study, participants will undergo assessments including measuring oxycodone levels in the blood over 24 hours to examine drug metabolism with and without kratom. Researchers will measure pupil size to evaluate opioid effects and monitor safety throughout. Participants must comply with dietary and medication restrictions and attend visits, with total involvement lasting as long as the four study arms require. This design aims to clarify how kratom may affect oxycodone's behavior and impact in the body.

Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints