Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes
NCT ID: NCT05511818
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
2679 participants
INTERVENTIONAL
2022-09-12
2023-04-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Placebo Control 1
Rest Product Form 1 - control
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Placebo Control 2
Rest Product Form 2 - control
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Placebo Control 3
Rest Product Form 3 - control
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Active Product 1.1
Rest Product Form 1 - active product 1
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Active Product 1.2
Rest Product Form 1 - active product 2
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Active Product 1.3
Rest Product Form 1 - active product 3
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Active Product 1.4
Rest Product Form 1 - active product 4
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Active Product 2.1
Rest Product Form 2 - active product 1
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Active Product 2.2
Rest Product Form 2 - active product 2
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Active Product 3.1
Rest Product Form 3 - active product 1
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Active Product 3.2
Rest Product Form 3 - active product 2
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Placebo Control 4
Rest Product Form 4 - control
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Active Product 4
Rest Product Form 4 - active product 1
Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Interventions
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Rest Study Product Usage
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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-22D03
Identifier Type: -
Identifier Source: org_study_id