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

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