NCT05552898

Radicle Sleep: A Study of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,750 (actual)
• Sponsor: Radicle Science · Industry
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The aim of this study is to determine the safety and effects (if any) of different single agent and combination cannabinoid formulations on self-reported sleep and health in adults (21 years of age and older) that reside in the USA. It is a virtual, direct-to-consumer study that will recruit up to 300 participants per study arm (up to 1800 total). Participants will be followed for 5 weeks as they answer electronic surveys about their health, study product usage, and its impact on their health. There are no in-person visits for this study. After study completion, study investigators will compare the effects of each cannabinoid study product to melatonin isolate. Study investigators will also run post-hoc analyses (correcting for multiple comparisons) to evaluate the significance of health score changes within individual study product arms, and whether there were significant differences in the effect with the addition of components to comparable cannabinoid study products.

Conditions

• Sleep

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sleep Study Product Usage	Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-05-31
• Completion: 2022-08-26
• First posted: 2022-09-23
• Last updated: 2023-11-22

Locations

1 site across 1 country: United States