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

Not Applicable

Completed

• Conditions: Sleep
• Interventions: Dietary Supplement: Sleep Study Product Usage

• Registration Number: NCT05552898
• Lead Sponsor: Radicle Science

Brief 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.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-08-26
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1750

Inclusion Criteria

• 21 years of age and older
• Resides in the United States
• Endorses symptoms of sleep disturbance
• Selects sleep disturbance as a primary reason for taking a cannabinoid product
• Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, CBG, CBC, CBN, THC) for the duration of participant engagement (5 weeks)
• Expresses an interest in taking a study product and not knowing the product identity until the end of the study

Exclusion Criteria

• Pregnant, trying to become pregnant, or breastfeeding
• Reports a diagnosis of liver disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Lack of reliable daily access to the internet
• Reports taking any medication that warns against grapefruit consumption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Product 1.2	Sleep Study Product Usage	Sleep Product Form 1 - active product 2
Active Product 1.4	Sleep Study Product Usage	Sleep Product Form 1 - active product 4
Placebo Control 1	Sleep Study Product Usage	Sleep Product Form 1 - control
Active Product 1.1	Sleep Study Product Usage	Sleep Product Form 1 - active product 1
Active Product 1.3	Sleep Study Product Usage	Sleep Product Form 1 - active product 3
Active Product 1.5	Sleep Study Product Usage	Sleep Product Form 1 - active product 5

Primary Outcome Measures

Name	Time	Method
Change in sleep disturbance	4 weeks	Sleep disturbance as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance SF 8A (Scoring from 8 to 40, with higher scores translating to greater sleep disturbance. Scores are standardized to US general population \[T-score mapping\])

Secondary Outcome Measures

Name	Time	Method
Change in overall well-being	4 weeks	Change in well-being as assessed by World Health Organization 5 (WHO-5 scale; Scoring from 0 to 25, with higher scores translating to greater well-being)
Change in pain	4 weeks	Pain as assessed by Pain on average, Enjoyment of life, and General activity Score (PEG; scale 0-10 where 0 is no pain)
Achievement of minimum clinically important difference (MCID) in sleep disturbance	4 weeks	Odds of achieving a MCID in sleep disturbance as assessed by Sleep disturbance as assessed by PROMIS Sleep Disturbance SF 8A
Change in sleep quantity	4 weeks	Sleep quantity as assessed by average hours of sleep reported per night
Change in anxiety	4 weeks	Anxiety as assessed by PROMIS Anxiety 4A (Scoring from 4 to 20, with higher scores translating to greater anxiety. Scores are standardized to US general population \[T-score mapping)\]

Trial Locations

Locations (1)

Radicle Science, Inc; 🇺🇸 Del Mar, California, United States