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

Recruiting now · Early Phase 1

Conditions studied: Herbal Interaction

In brief

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

Key facts

Study ID: NCT05846451
Run by: Washington State University
People needed: 16
Starts: 2023-06-01
Expected to finish: 2026-12-01
Last updated by the study team: 2026-06-03

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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 caffeinated beverages or other caffeine-containing products the evening before and morning of any inpatient visit
Willing to abstain from consuming alcoholic beverages for one day prior to any inpatient visit
Willing to use an additional method of contraception that does not include oral contraceptive pills, patches, or other hormonal methods (such as abstinence, copper IUD, or condoms)
Have consumed kratom previously and tolerated it well without any unpleasant effects
Willing to abstain from kratom for several weeks
Have consumed any opioid previously and tolerated it well without any unpleasant effects or addiction
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for the subject to comply with the requirements of the study
Geographically located within a 40-mile radius of Spokane and have the time to participate

You may not qualify if…

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
No previous exposure to kratom
No previous exposure to an opioid
History of anemia or any other significant hematologic disorder
History of substance abuse, dependence, or addiction or major psychiatric illness
A need for chronic opioid analgesics
Use of opioid analgesics 3 weeks prior to initiation of the study
An imminent likely need for opioid analgesics (e.g., planned dental or surgical procedure)
Pregnant or nursing
History of allergy or intolerance to kratom, other opioids, or oxycodone
Taking concomitant medications, both prescription and non-prescription (including dietary supplements/botanical products), known to alter the pharmacokinetics of kratom or oxycodone
Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
History of sleep apnea
Any prior use of amphetamines, benzodiazepines, cocaine, MDMA, opioids, PCP, or other drugs for recreational purposes
Use of cannabis/marijuana, hemp, THC-containing products, CBD-containing products, or CBD within the last month
Out-of-range clinical laboratory value that the study physician considers participation in the study a health risk
Inability to speak, read, and understand English

Where it is running

Washington State University College of Pharmacy and Pharmaceutical Sciences — Spokane, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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