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

Sleep Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep
• Sleep Disorder
• Sleep Disturbance
• Sleep Wake Disorders

• NCT number: NCT05511818
• Study type: Interventional
• Source: Radicle Science
• Status: Completed
• Phase: N/A
• Start date: September 12, 2022
• Completion date: April 11, 2023