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

Radicle Science

Status: Completed

Conditions: Energy

Treatments: Dietary Supplement: Energy Study Product Usage

Study type: Interventional

Funder types: Industry

Identifiers

NCT05502328

RADX-22D02

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,427 patients

Sex: All

Ages: 21 to 105 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,427 participants in 6 patient groups, including a placebo group

Control 1

Placebo Comparator group

Description:

Energy Product Form 1 - control

Treatment:

Dietary Supplement: Energy Study Product Usage

Control 2

Placebo Comparator group

Description:

Energy Product Form 2 - control

Treatment:

Dietary Supplement: Energy Study Product Usage

Energy Product 1.1

Experimental group

Description:

Energy Product Form 1 - active product 1

Treatment:

Dietary Supplement: Energy Study Product Usage

Energy Product 1.2

Experimental group

Description:

Energy Product Form 1 - active product 2

Treatment:

Dietary Supplement: Energy Study Product Usage

Energy Product 2.1

Experimental group

Description:

Energy Product Form 2 - active 1

Treatment:

Dietary Supplement: Energy Study Product Usage

Energy Product 2.2

Experimental group

Description:

Energy Product Form 2 - active 2

Treatment:

Dietary Supplement: Energy Study Product Usage