The Pharmacokinetics and Pharmacodynamics of Hemp-based Topical Cannabinoid Products

Exclusion Criteria

• •1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month prior to the screening visit.
• •2. History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
• •3. Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), vitamin(s), or prescription medications (with the exception of birth control prescriptions) within 14 days of study entry; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
• •4. Use of hemp seeds or hemp oil in any form in the past 3 months.
• •5. Use of dronabinol (Marinol) within the past 6 months.
• •6. History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
• •7. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
• •8. Known allergy to any ingredients in the active or placebo topical products.
• •9. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
• •10. Epilepsy or a history of seizures.
• •11. Individuals with anemia.