NCT05511818

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,679 (actual)
• Sponsor: Radicle Science · Industry
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Sleep
• Sleep Disturbance
• Sleep Disorder

Interventions

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

Timeline

• Start date: 2022-09-12
• Primary completion: 2022-12-31
• Completion: 2023-04-11
• First posted: 2022-08-23
• Last updated: 2023-11-22

Locations

1 site across 1 country: United States