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

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