Radicle Sleep: A Study of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes
NCT ID: NCT05552898
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1750 participants
INTERVENTIONAL
2022-03-01
2022-08-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Placebo Control 1
Sleep Product Form 1 - control
Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Active Product 1.1
Sleep Product Form 1 - active product 1
Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Active Product 1.2
Sleep Product Form 1 - active product 2
Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Active Product 1.3
Sleep Product Form 1 - active product 3
Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Active Product 1.4
Sleep Product Form 1 - active product 4
Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Active Product 1.5
Sleep Product Form 1 - active product 5
Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Interventions
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Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
105 Years
ALL
Yes
Sponsors
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Radicle Science
INDUSTRY
Responsible Party
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Principal Investigators
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Emily K Pauli, PharmD
Role: PRINCIPAL_INVESTIGATOR
Radicle Science Inc.
Locations
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Radicle Science, Inc
Del Mar, California, United States
Countries
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Related Links
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Radicle Science, Inc
Other Identifiers
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RADX-22D01
Identifier Type: -
Identifier Source: org_study_id