NCT05846451

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Washington State University · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to investigate whether the botanical product kratom affects how the body processes the opioid drug oxycodone. The main research questions to be answered are two-fold: 1. How does kratom affect the manner in which oxycodone is metabolized (broken down and removed) by the body? 2. Does kratom change the effects oxycodone exerts on the body? Healthy adult participants will complete four study arms, during which they will be given the following: * Kratom (as a tea) * A single dose of oxycodone (as a tablet) * Kratom tea and a single dose of oxycodone * Kratom tea for four days, then kratom tea and a single dose of oxycodone

Detailed description

The primary objective of this study is to evaluate the potential for kratom to precipitate a pharmacokinetic interaction with the common opioid and dual cytochrome P450 (CYP) 3A/CYP2D6 substrate oxycodone. A secondary objective is to evaluate a potential pharmacodynamic interaction by measuring pupil diameter, the most sensitive measure of central nervous system opioid effects. To evaluate these objectives, participants will complete four arms, during which they will be administered the following: * Arm 1: a single low dose of kratom (by mouth, as a tea) * Arm 2: a single low dose of immediate-release oxycodone (by mouth, as a tablet) * Arm 3: a single low dose of kratom tea and a single low dose of oxycodone * Arm 4: daily at-home self-administration of kratom tea for four days, followed immediately by a single low dose of kratom tea and a single low dose of oxycodone in the research setting

Conditions

• Herbal Interaction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Kratom	Kratom (Moon Kratom Yellow Indonesian, lot 51) is supplied as a dry leaf powder in clear plastic bags, each weighing 5 kg. Two grams of kratom dry leaf powder will be stirred into 240 mL of hot water to make a tea. The tea will be cooled to 50 degrees Celsius before administration. Participants will drink the tea within 15 minutes.
DRUG	Oxycodone	Immediate-release oral tablet, 10 mg

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2023-05-06
• Last updated: 2024-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study