Radicle™ Energy: A Randomized, Blinded, Placebo-controlled Study of Cannabinoid Formulations and Their Effects on Energy Levels, Focus, Appetite and Other Health Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,427
- Locations
- 2
- Primary Endpoint
- Change in energy
Study Overview
Brief Summary
A randomized, blinded, placebo-controlled study of cannabinoid formulations and their effects on energy levels, focus, appetite and other health outcomes
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Masking Description
The investigator is blinded to the participants assigned study products. Participants are blinded to the study product they received.
Eligibility Criteria
- Ages
- 21 Years to 105 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •21 years of age and older
- •Resides in the United States
- •Endorses: a desire for more energy (less fatigue) and/or a desire for better concentration (focus/attention)
- •Selects more energy and/or better concentration as a primary reason for taking a cannabinoid product
- •Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e.
- •CBD, THC) for the duration of participant engagement
- •Expresses a willingness to take 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 Calculated BMI 18.5 or less
Outcomes
Primary Outcomes
Change in energy
Time Frame: 4 weeks
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)
Change in focus
Time Frame: 4 weeks
Change in concentration (ability to focus) score as assessed by PROMIS™ Cognition 6a (scale 1-5; where lower score is worse focus (cognitive function))
Secondary Outcomes
- Change in body weight(4 weeks)
- Change in overall quality of life (QOL)(4 weeks)
- Change in appetite(4 weeks)
- Change in energy (measure 2)(4 weeks)
- Change in overall well-being(4 weeks)