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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-45
SponsorWashington State University

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Kratom
  • Oxycodone

Treatment groups

16 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Washington State University

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator