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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05511818
• Other study ID #: RADX-22D03
• Status: Completed
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: April 11, 2023

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2679
• Est. completion date: April 11, 2023
• Est. primary completion date: December 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 a desire for better sleep

• Selects sleep 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

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

Intervention

Dietary Supplement:
• Rest Study Product Usage
Participants will use their Radicle Rest 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	Mean difference in sleep disturbance score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)	4 weeks
Secondary	Change in overall well-being	Mean difference in well-being score as assessed by World Health Organization 5 (WHO 5; scale 0-25; with 0 representing the worst imaginable well-being and 25 representing the best imaginable well-being)	4 weeks
Secondary	Change in overall quality of life (QOL)	Mean difference in QOL score as assessed by Kemp QOL (scale 1-7; with 1 representing very poor QOL and 7 representing excellent QOL)	4 weeks
Secondary	Change in anxiety	Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)	4 weeks
Secondary	Change in pain	Mean difference in pain score as assessed by the Pain on average, Enjoyment of life, and General activity score (PEG; scale 0-10; with 0 representing no pain and 10 representing the worst pain imaginable that completely interferes with enjoyment of life and general activities)	4 weeks
Secondary	Change in stress	Mean difference in stress score as assessed by PROMIS Stress 4A (scale 4-20; where higher scores correspond to more severe stress)	4 weeks
Secondary	Change in fatigue	Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)	4 weeks
Secondary	Minimal clinically important difference (MCID) in sleep disturbance	Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)	4 weeks

External Links

•   Radicle Science, Inc