Clinical trial NCT05502328: Radicle Energy: A Study of Cannabinoids on Energy and Other Health Outcomes
Official title: Radicle™ Energy: A Randomized, Blinded, Placebo-controlled Study of Cannabinoid Formulations and Their Effects on Energy Levels, Focus, Appetite and Other Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy
Lead sponsor: Radicle Science
Sponsor class: INDUSTRY
First posted: 2022-08-16
Enrollment: 1427
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in energy
timeFrame: 4 weeks
measure: Change in focus
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in energy (measure 2)
timeFrame: 4 weeks
measure: Change in body weight
timeFrame: 4 weeks
measure: Change in appetite
timeFrame: 4 weeks
measure: Change in overall quality of life (QOL)
timeFrame: 4 weeks
measure: Change in overall well-being
timeFrame: 4 weeks
Other outcomes:
measure: Change in pain
timeFrame: 4 weeks
measure: Change in Sleep quality
timeFrame: 4 weeks
measure: Change in feelings of anxiety
timeFrame: 4 weeks
measure: Change in Stress
timeFrame: 4 weeks
Locations:
city: Del Mar
country: United States
facility: Radicle Science, Inc
state: California
Study officials:
affiliation: Radicle Science, Inc
name: Emily K Pauli, PharmD
role: PRINCIPAL_INVESTIGATOR
References: