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A randomized, blinded, controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control 1 | Placebo Comparator | Sleep Product Form 1 - control |
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| Active Product 1.1 | Experimental | Sleep Product Form 1 - active product 1 |
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| Active Product 1.2 | Experimental | Sleep Product Form 1 - active product 2 |
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| Active Product 1.3 | Experimental | Sleep Product Form 1 - active product 3 |
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| Active Product 1.4 | Experimental | Sleep Product Form 1 - active product 4 |
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| Active Product 1.5 | Experimental | Sleep Product Form 1 - active product 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Study Product Usage | Dietary Supplement | Participants will use their Radicle Sleep study product as directed for a period of 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep disturbance | 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]) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep quantity | Sleep quantity as assessed by average hours of sleep reported per night | 4 weeks |
| Change in overall well-being | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily K Pauli, PharmD | Radicle Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radicle Science, Inc | Del Mar | California | 92014 | United States |
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| Label | URL |
|---|---|
| Radicle Science, Inc | View source |
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Data will not be shared with researchers outside of Radicle Collaborators on this study.
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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
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The investigator is blinded to the participants assigned study products. Participants are blinded to the study product they received.
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| 4 weeks |
| Change in anxiety | 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 weeks |
| Change in pain | Pain as assessed by Pain on average, Enjoyment of life, and General activity Score (PEG; scale 0-10 where 0 is no pain) | 4 weeks |
| Achievement of minimum clinically important difference (MCID) in sleep disturbance | Odds of achieving a MCID in sleep disturbance as assessed by Sleep disturbance as assessed by PROMIS Sleep Disturbance SF 8A | 4 weeks |