Radicle Energy: A Study of Cannabinoids on Energy and Other Health Outcomes

Radicle™ Energy: A Randomized, Blinded, Placebo-controlled Study of Cannabinoid Formulations and Their Effects on Energy Levels, Focus, Appetite and Other Health Outcomes

A randomized, blinded, placebo-controlled study of cannabinoid formulations and their effects on energy levels, focus, appetite and other health outcomes

Study Overview

• Status: Completed
• Conditions: Energy
• Intervention / Treatment: Dietary supplement: Energy Study Product Usage

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 Type: Interventional
• Enrollment (Actual): 1427
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014
      • Radicle Science, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control 1; Energy Product Form 1 - control	Dietary supplement: Energy Study Product Usage; Participants will use their Radicle Energy study product as directed for a period of 4 weeks.
Placebo Comparator: Control 2; Energy Product Form 2 - control	Dietary supplement: Energy Study Product Usage; Participants will use their Radicle Energy study product as directed for a period of 4 weeks.
Experimental: Energy Product 1.1; Energy Product Form 1 - active product 1	Dietary supplement: Energy Study Product Usage; Participants will use their Radicle Energy study product as directed for a period of 4 weeks.
Experimental: Energy Product 1.2; Energy Product Form 1 - active product 2	Dietary supplement: Energy Study Product Usage; Participants will use their Radicle Energy study product as directed for a period of 4 weeks.
Experimental: Energy Product 2.1; Energy Product Form 2 - active 1	Dietary supplement: Energy Study Product Usage; Participants will use their Radicle Energy study product as directed for a period of 4 weeks.
Experimental: Energy Product 2.2; Energy Product Form 2 - active 2	Dietary supplement: Energy Study Product Usage; Participants will use their Radicle Energy study product as directed for a period of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Emily K Pauli, PharmD, Radicle Science, Inc

Publications and helpful links

Helpful Links

• Radicle Science, Inc

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RADX-22D02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with researchers outside of Radicle Collaborators on this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No