Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints
Washington State University
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
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 immediat…
Eligibility
- Age range
- 21–45 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Males and females, aged from 21-45 years and healthy * Body weight between 130 and 250 pounds (60-115 kg) and body mass index between 19 and 30 * Not taking any medications (prescription and non-prescription) or dietary supplements/botanical products known to alter the pharmacokinetics of either oxycodone or kratom * Willing to abstain from consuming dietary supplements/botanical products and fruit juices for several weeks * Willing to abstain from cannabis/marijuana, hemp, and THC- and/or CBD-containing products for several weeks * Willing to abstain from consuming caff…
Interventions
- Dietary SupplementKratom
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.
- DrugOxycodone
Immediate-release oral tablet, 10 mg
Location
- Washington State University College of Pharmacy and Pharmaceutical SciencesSpokane, Washington