Radicle™ Rest: A Randomized, Blinded, Placebo-controlled, Direct-to-consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,679
- Locations
- 2
- Primary Endpoint
- Change in sleep disturbance
Study Overview
Brief Summary
A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Masking Description
The investigator is blinded to the participants assigned study products. Participants are blinded to the study product they received.
Eligibility Criteria
- Ages
- 21 Years to 105 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in sleep disturbance
Time Frame: 4 weeks
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)
Secondary Outcomes
- Change in overall well-being(4 weeks)
- Change in anxiety(4 weeks)
- Change in overall quality of life (QOL)(4 weeks)
- Change in stress(4 weeks)
- Change in pain(4 weeks)
- Change in fatigue(4 weeks)
- Minimal clinically important difference (MCID) in sleep disturbance(4 weeks)