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

Eligibility 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
• * 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