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A randomized, blinded, placebo-controlled study of cannabinoid formulations and their effects on energy levels, focus, appetite and other health outcomes
This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm (3000 total), age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for more energy (less fatigue and/or better concentration/focus during screening); (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) indicate an interest in taking a plant derived cannabinoid product to help with their energy and/or focus.
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. People with a calculated BMI of 18.5 or less 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control 1 | Placebo Comparator | Energy Product Form 1 - control |
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| Control 2 | Placebo Comparator | Energy Product Form 2 - control |
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| Energy Product 1.1 | Experimental | Energy Product Form 1 - active product 1 |
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| Energy Product 1.2 | Experimental | Energy Product Form 1 - active product 2 |
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| Energy Product 2.1 | Experimental | Energy Product Form 2 - active 1 |
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| Energy Product 2.2 | Experimental | Energy Product Form 2 - active 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Study Product Usage | Dietary Supplement | Participants will use their Radicle Energy study product as directed for a period of 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in energy | Change in mean energy score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 7a (scale 1-5; where lower score is less fatigue) | 4 weeks |
| Change in focus | Change in concentration (ability to focus) score as assessed by PROMIS™ Cognition 6a (scale 1-5; where lower score is worse focus (cognitive function)) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in energy (measure 2) | Change in energy level score as assessed by a visual analog scale (VAS; Scoring from 0 to 10, with 0 being 'No energy' and 10 being 'More than enough energy') | 4 weeks |
| Change in body weight |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain | Change in pain score as assessed by the Pain on average, Enjoyment of life, and General activity Score (PEG; scale 0-10 where 0 is no pain) | 4 weeks |
| Change in Sleep quality | Change in sleep quality (sleep disturbance) score as assessed by the PROMIS Sleep Disturbance 4A (scale 4 to 20; where higher scores correspond to higher levels of sleep disturbance) |
Inclusion Criteria:
CBD, THC) for the duration of participant engagement
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 Calculated BMI 18.5 or less
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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.
|
Change in body weight as assessed by self-reported body weight in pounds
| 4 weeks |
| Change in appetite | Change in appetite as assessed by a visual appetite scale (VAS; Scoring from 0 to 10, with 0 being 'No hunger' and 10 being 'Always hungry') | 4 weeks |
| Change in overall quality of life (QOL) | Change in QOL score as assessed by Kemp QOL (scale 1-7; with higher scores corresponding to higher quality of life) | 4 weeks |
| Change in overall well-being | Change in well-being score as assessed by World Health Organization 5 Well-being Index (WHO-5 Well-being Index; with higher scores corresponding to greater well-being) | 4 weeks |
| 4 weeks |
| Change in feelings of anxiety | Change in anxiety score as assessed by the PROMIS Anxiety 4a (scale 4-20; where higher scores correspond to greater levels of anxiety) | 4 weeks |
| Change in Stress | Change in stress score as assessed by the PROMIS Stress 4a (scale 4-20; where higher scores correspond to greater levels of stress) | 4 weeks |