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

Sleep Clinical Trial

Official title:

Radicle™ Sleep: A Randomized, Blinded, Controlled, Direct-to-Consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05552898
• Other study ID #: RADX-22D01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 26, 2022

Study information

• Verified date: November 2023
• Source: Radicle Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1750
• Est. completion date: August 26, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Dietary Supplement:
• Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.

Locations

Country	Name	City	State
United States	Radicle Science, Inc	Del Mar	California

Sponsors (1)

Lead Sponsor	Collaborator
Radicle Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in sleep quantity	Sleep quantity as assessed by average hours of sleep reported per night	4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Radicle Science, Inc