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

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

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Dietary supplement: Sleep Study Product Usage

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 Type: Interventional
• Enrollment (Actual): 1750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014
      • Radicle Science, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control 1; Sleep Product Form 1 - control	Dietary supplement: Sleep Study Product Usage; Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Experimental: Active Product 1.1; Sleep Product Form 1 - active product 1	Dietary supplement: Sleep Study Product Usage; Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Experimental: Active Product 1.2; Sleep Product Form 1 - active product 2	Dietary supplement: Sleep Study Product Usage; Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Experimental: Active Product 1.3; Sleep Product Form 1 - active product 3	Dietary supplement: Sleep Study Product Usage; Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Experimental: Active Product 1.4; Sleep Product Form 1 - active product 4	Dietary supplement: Sleep Study Product Usage; Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Experimental: Active Product 1.5; Sleep Product Form 1 - active product 5	Dietary supplement: Sleep Study Product Usage; Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep disturbance	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])	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep quantity	Sleep quantity as assessed by average hours of sleep reported per night	4 weeks
Change in overall well-being	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)	4 weeks
Change in anxiety	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)]	4 weeks
Change in pain	Pain as assessed by Pain on average, Enjoyment of life, and General activity Score (PEG; scale 0-10 where 0 is no pain)	4 weeks
Achievement of minimum clinically important difference (MCID) in sleep disturbance	Odds of achieving a MCID in sleep disturbance as assessed by Sleep disturbance as assessed by PROMIS Sleep Disturbance SF 8A	4 weeks

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Emily K Pauli, PharmD, Radicle Science, Inc

Publications and helpful links

Helpful Links

• Radicle Science, Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): August 26, 2022

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RADX-22D01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with researchers outside of Radicle Collaborators on this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No