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Radicle™ Sleep: A Randomized, Blinded, Controlled, Direct-to-Consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes
A randomized, blinded, controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes
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.
Age
21 - 105 years
Sex
ALL
Healthy Volunteers
Yes
Radicle Science, Inc
Del Mar, California, United States
Start Date
March 1, 2022
Primary Completion Date
May 31, 2022
Completion Date
August 26, 2022
Last Updated
November 22, 2023
1,750
ACTUAL participants
Sleep Study Product Usage
DIETARY_SUPPLEMENT
Lead Sponsor
Radicle Science
NCT06430957
NCT01778504
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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