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 19and 30

• Not taking any medications (prescription and non-prescription) or dietarysupplements/botanical products known to alter the pharmacokinetics of eitheroxycodone or kratom

• Willing to abstain from consuming dietary supplements/botanical products and fruitjuices for several weeks

• Willing to abstain from cannabis/marijuana, hemp, and THC- and/or CBD-containingproducts for several weeks

• Willing to abstain from consuming caffeinated beverages or other caffeine-containingproducts the evening before and morning of any inpatient visit

• Willing to abstain from consuming alcoholic beverages for one day prior to anyinpatient visit

• Willing to use an additional method of contraception that does not include oralcontraceptive pills, patches, or other hormonal methods (such as abstinence, copperIUD, 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 unpleasanteffects or addiction

• Written informed consent (and assent when applicable) obtained from subject orsubject's legal representative and ability for the subject to comply with therequirements of the study

• Geographically located within a 40-mile radius of Spokane and have the time toparticipate

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 kidneydisease, 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 surgicalprocedure)

• Pregnant or nursing

• History of allergy or intolerance to kratom, other opioids, or oxycodone

• Taking concomitant medications, both prescription and non-prescription (includingdietary supplements/botanical products), known to alter the pharmacokinetics ofkratom 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, orother 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 considersparticipation in the study a health risk

• Inability to speak, read, and understand English