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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05552898
Recruitment Status : Completed
First Posted : September 23, 2022
Last Update Posted : September 23, 2022
Sponsor:
Information provided by (Responsible Party):
Radicle Science

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

Condition or disease Intervention/treatment Phase
Sleep Dietary Supplement: Sleep Study Product Usage Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be stratified based on gender and endorsement of problems with energy and/or focus reported during enrollment, then randomized to one of the study arms
Masking: Single (Participant)
Masking Description: Participants will be blinded to the product they receive.
Primary Purpose: Other
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
Actual Study Start Date : March 1, 2022
Actual Primary Completion Date : May 31, 2022
Actual Study Completion Date : August 26, 2022
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Control 1
Sleep Product Form 1 - control
 Dietary Supplement: Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Experimental: Active Product 1.1
Sleep Product Form 1 - active product 1
 Dietary Supplement: Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Experimental: Active Product 1.2
Sleep Product Form 1 - active product 2
 Dietary Supplement: Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Experimental: Active Product 1.3
Sleep Product Form 1 - active product 3
 Dietary Supplement: Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Experimental: Active Product 1.4
Sleep Product Form 1 - active product 4
 Dietary Supplement: Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
Experimental: Active Product 1.5
Sleep Product Form 1 - active product 5
 Dietary Supplement: Sleep Study Product Usage
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change in sleep disturbance [ Time Frame: 4 weeks ]
    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])


Secondary Outcome Measures :
  1. Change in sleep quantity [ Time Frame: 4 weeks ]
    Sleep quantity as assessed by average hours of sleep reported per night

  2. Change in overall well-being [ Time Frame: 4 weeks ]
    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)

  3. Change in anxiety [ Time Frame: 4 weeks ]
    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. Change in pain [ Time Frame: 4 weeks ]
    Pain as assessed by Pain on average, Enjoyment of life, and General activity Score (PEG; scale 0-10 where 0 is no pain)

  5. Achievement of minimum clinically important difference (MCID) in sleep disturbance [ Time Frame: 4 weeks ]
    Odds of achieving a MCID in sleep disturbance as assessed by Sleep disturbance as assessed by PROMIS Sleep Disturbance SF 8A


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05552898


Locations
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United States, California
Radicle Science, Inc
Del Mar, California, United States, 92014
Sponsors and Collaborators
Radicle Science
Investigators
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Principal Investigator: Emily K Pauli, PharmD Radicle Science, Inc
More Information
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Additional Information:

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Responsible Party: Radicle Science
ClinicalTrials.gov Identifier: NCT05552898    
Other Study ID Numbers: RADX-22D01
First Posted: September 23, 2022    Key Record Dates
Last Update Posted: September 23, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared with researchers outside of Radicle Collaborators on this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No