NCT05846451 · Washington State University
Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints
What this study is about
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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Kratom
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.
DRUG
Oxycodone
Immediate-release oral tablet, 10 mg
Primary outcome measures
Oxycodone area under the concentration vs. time curve (AUC) ratio (presence to absence of kratom)
Time frame: 0-24 hours
Ratio of the AUC of oxycodone in the presence to absence of kratom.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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 criteria
- 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
- Spokane, Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations