A Double-Blind, Randomized, Placebo-Controlled Study of Various Cannabinoids on Sleep Quality

Exclusion criteria

• Participants meeting any of the following criteria will not be eligible for participation in the study: 1. Person has a known history of significant allergic condition or significant hypersensitivity to cannabis, cannabinoid medications, hemp products, melatonin, or excipients of the IP. 2. Person has been exposed to any investigational drug or device \< 30 days prior to screening or plans to use an investigational drug or device during the study. 3. Person has had a change in allowable medication, tobacco, alcohol, caffeine, cannabis (including individual or combination cannabinoid products), or supplement dose or regimen within 30 days of screening or has any plans to change dose or regimen during the study. 4. Person has used tetrahydrocannabinol (THC; e.g., delta-9, delta-8) or cannabinol (CBN)-containing product more than four times per week during the prior 30 days of screening or during the study. 5. Person has history of use of any synthetic cannabinoid receptor agonist (e.g., spice, K2) within the past year. 6. Person has used illicit substances (e.g., amphetamine, cocaine, methamphetamine, MDMA, LSD, ketamine, heroin, psilocybin, salvia, prescription medications not prescribed to the person) in the past 30 days or plans to use them during the study. 7. Person is currently using products or medications that may interact or overlap with one or more of the ingredients in the IP, including the following drugs or supplements: warfarin, clobazam, valproic acid, phenobarbital, mechanistic target of rapamycin \[mTOR\] inhibitors, oral tacrolimus, St. John's wort, Epidiolex, sleep supplements or prescription sleep aids. 8. Person has a positive screen (i.e., exceeds cut-point score) for any of the following sleep disorders on the Sleep Disorders Symptom Checklist-17 (SDS-CL-17): narcolepsy, obstructive sleep apnea, restless legs syndrome. 9. Person works night or swing shift. 10. Person has a personal or family history (first-degree relative) of a psychotic disorder and/or schizophrenia. 11. Person has an acute or progressive disease or disorder that is likely to interfere with the objectives of the study, or the ability to adhere to protocol requirements. 12. Person is currently pregnant, breastfeeding, or planning to become pregnant within 30 days of the study. 13. Woman of childbearing potential, unless she has not engaged in vaginal intercourse, or she has used effective contraception when doing so (for example, double barrier), for at least 30 days prior to the study. 14. Woman of childbearing potential, unless willing to ensure that she or her partner use effective contraception (for example, double barrier) during the study and for 30 days thereafter (however, a male condom should not be used in conjunction with a female condom). 15. Man whose partner is of childbearing potential, unless willing to ensure that he or his partner use effective contraception (for example, double barrier) during the study and for 30 days thereafter (however, a male condom should not be used in conjunction with a female condom). 16. Person has history of diagnosis related to hepatic function and/or significantly impaired hepatic function (alanine aminotransferase \[ALT\] \>5 ⋅ upper limit of normal \[ULN\] or total bilirubin \[TBL\] \>2 ⋅ ULN) OR the ALT or aspartate aminotransferase (AST) \>3 ⋅ ULN and TBL \>2 ⋅ ULN (or international normalized ratio \[INR\] \>1.5). 17. Person demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.