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Kratom and Oxycodone Interaction Study

This study is looking at how kratom, an herbal product, affects the body's processing of oxycodone, a pain medication. Researchers want to understand if kratom changes how oxycodone is broken down and removed from your body, and if it changes the effects oxycodone has. Healthy adults between 21 and 45 years old can join. You should weigh between 130 and 250 pounds and have a body mass index (BMI) between 19 and 30. The study will measure how much oxycodone is in your body over 24 hours to see if kratom makes a difference. The current status of this study is unclear.

Study design
This interventional study plans to enroll 16 healthy adult participants. It involves four different treatment arms where participants will receive kratom, oxycodone, or both.
What's involved
Participants will complete four study arms, which involve taking kratom tea, an oxycodone tablet, or both. One arm includes taking kratom tea daily at home for four days.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement of oxycodone levels will be taken over 0-24 hours after administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05846451

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

Recruiting
EARLY_PHASE1Ages 21–45InterventionalBasic science
Washington State University
~16 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:KratomOxycodone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Oxycodone area under the concentration vs. time curve (AUC) ratio (presence to absence of kratom)
Measured over 0-24 hours

Conditions

Herbal Interaction

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Healthy Volunteers

NCT05846451

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Washington State University College of Pharmacy and Pharmaceutical Sciences

    Spokane, Washingtonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Mary Paine, PhD
[email protected]
509-358-7759
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Oxycodone area under the concentration vs. time curve (AUC) ratio (presence to absence of kratom)0-24 hours

    Ratio of the AUC of oxycodone in the presence to absence of kratom.