Cannabinoid Tablets for the Treatment of Pain From Osteoarthritis of the Knee

Exclusion Criteria

• •1. Subject is pregnant or lactating;
• •2. Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops), palmitoylethanolamide, or terpenes;
• •3. Subject has a known allergy to active or inert ingredients of the investigational product;
• •4. Subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drug's effects (examples include: Cannabis or any cannabinoid products; Any drug or herbal product that influences the endocannabinoid system (ECS));
• •5. Subject is taking marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD for at least 14 days prior to this study, and does not promise that they will not take marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD while participating in this study;
• •6. Subject is currently being treated with antibiotics for sinus, throat, or lung infections;
• •7. Subject has shortness of breath associated with allergies;
• •8. Subject has uncontrolled asthma;
• •9. Subject has a fever and/or productive cough;
• •10. Subject has unstable angina, uncontrolled hypertension;
• •11. Subject currently or has a history of congestive heart failure;
• •12. Subject has any other unstable medical condition;
• •13. Subject has a personal or family history of schizophrenia;
• •14. Subject has a personal history or currently has suicidal ideation or attempted suicide;
• •15. Subject has a major neurological disorder, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures.
• •16. Subject has taken pharmaceutical pain medicine, including OTC pain medicine of any kind, or has taken a NSAID and/or acetaminophen within 2 days of starting study treatment.
• •17. Subject has taken a prohibited medication during the screening period and prior to starting study treatment or is unwilling to stop these medications.
• •18. Subject has an allergy to, or has an intolerance to, NSAIDs or acetaminophen.
• •19. Subject has taken any form of steroids, including a local steroid injection in the knee, within 1 month of starting study treatment.
• •20. Subject has received any invasive interventions or surgery of the knee.
• •21. Subject has a history of substance or alcohol abuse.
• •22. Subject has clinically significant illness, including cardiovascular disorders.
• •23. Subject has any condition in which the investigator believes will confound the data of the study or could put the subject at risk of harm.
• •24. Subject does not have access to a smart phone or does not know how to use a smart phone application.