Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes

Radicle™ Rest: A Randomized, Blinded, Placebo-controlled, Direct-to-consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes

A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes

This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for better sleep, (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver disease, heavy drinkers, and those who are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking medications that warn against grapefruit consumption will be excluded.

Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Inclusion Criteria:

• 21 years of age and older
• Resides in the United States
• Endorses a desire for better sleep
• Selects sleep as a primary reason for taking a cannabinoid product
• Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, CBG, CBC, CBN, THC) for the duration of participant engagement (5 weeks)
• Expresses an interest in taking a study product and not knowing the product identity until the end of the study

Exclusion Criteria:

• Pregnant, trying to become pregnant, or breastfeeding
• Reports a diagnosis of liver disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Lack of reliable daily access to the internet
• Reports taking any medication that warns against grapefruit consumption