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

Sleep Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Sleep

• NCT number: NCT05552898
• Study type: Interventional
• Source: Radicle Science
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Completion date: August 26, 2022