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
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
Males and females under the age of 21 or over the age of 45
People who weigh less than 130 pounds or more than 250 pounds
People with a body mass index less than 19 or greater than 30
Any current major illness or chronic illness including but not limited to kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS
Crossover
Kratom
Dietary supplementKratom (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.
Oxycodone
DrugImmediate-release oral tablet, 10 mg
Oxycodone area under the concentration vs. time curve (AUC) ratio (presence to absence of kratom)
Ratio of the AUC of oxycodone in the presence to absence of kratom.
Area under the pupil diameter (effect) vs. time curve (AUEC) ratio
Ratio of AUEC in presence of oxycodone+kratom to oxycodone
Oxycodone maximum plasma concentration (Cmax) ratio (presence to absence of kratom)
Ratio of Cmax of oxycodone in the presence to absence of kratom.
Oxycodone half-life ratio (presence to absence of kratom)
Ratio of half-life of oxycodone in the presence to absence of kratom
Click on the lead sponsor to view all of their trials.
Washington State University
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
