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Completed

NCT Number: NCT05502328

Radicle Energy: A Study of Cannabinoids on Energy 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

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Key information

Conditions

Energy

Age range

21 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radicle Science, Inc

Del Mar, California, 92014, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Energy Study Product Usage

Dietary Supplement

Participants will use their Radicle Energy study product as directed for a period of 4 weeks.

Primary outcomes

  1. 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)

  2. 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

  1. Change in energy (measure 2)

    Time frame: 4 weeks

    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')

  2. Change in body weight

    Time frame: 4 weeks

    Change in body weight as assessed by self-reported body weight in pounds

  3. Change in appetite

    Time frame: 4 weeks

    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. Change in overall quality of life (QOL)

    Time frame: 4 weeks

    Change in QOL score as assessed by Kemp QOL (scale 1-7; with higher scores corresponding to higher quality of life)

  5. Change in overall well-being

    Time frame: 4 weeks

    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)

Other outcomes

  1. Change in pain

    Time frame: 4 weeks

    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)

  2. Change in Sleep quality

    Time frame: 4 weeks

    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)

  3. Change in feelings of anxiety

    Time frame: 4 weeks

    Change in anxiety score as assessed by the PROMIS Anxiety 4a (scale 4-20; where higher scores correspond to greater levels of anxiety)

  4. Change in Stress

    Time frame: 4 weeks

    Change in stress score as assessed by the PROMIS Stress 4a (scale 4-20; where higher scores correspond to greater levels of stress)

Sponsors and collaborators

Lead sponsor

Radicle Science

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 16, 2022
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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