EnergyNCT05502328
Radicle Energy: A Study of Cannabinoids on Energy and Other Health Outcomes
A study testing Energy Study Product Usage in people with Energy, run by Radicle Science at 1 site in United States.
Trial summary
A randomized, blinded, placebo-controlled study of cannabinoid formulations and their effects on energy levels, focus, appetite and other health outcomes Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy
- What is being tested?
- Energy Study Product Usage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,427 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2022to 24 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
A randomized, blinded, placebo-controlled study of cannabinoid formulations and their effects on energy levels, focus, appetite and other health outcomes
Read the 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.
- Conditions
- Energy
- Being tested
- Energy Study Product Usage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy Study Product UsageDietary supplement
Participants will use their Radicle Energy study product as directed for a period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control 1 | Placebo comparator | Energy Product Form 1 - control Receives: Dietary Supplement: Energy Study Product Usage |
| Control 2 | Placebo comparator | Energy Product Form 2 - control Receives: Dietary Supplement: Energy Study Product Usage |
| Energy Product 1.1 | Experimental | Energy Product Form 1 - active product 1 Receives: Dietary Supplement: Energy Study Product Usage |
| Energy Product 1.2 | Experimental | Energy Product Form 1 - active product 2 Receives: Dietary Supplement: Energy Study Product Usage |
| Energy Product 2.1 | Experimental | Energy Product Form 2 - active 1 Receives: Dietary Supplement: Energy Study Product Usage |
| Energy Product 2.2 | Experimental | Energy Product Form 2 - active 2 Receives: Dietary Supplement: Energy Study Product Usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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))
Measured: 4 weeks
Secondary outcomes (5)
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')
Measured: 4 weeks
Change in body weight
Change in body weight as assessed by self-reported body weight in pounds
Measured: 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')
Measured: 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)
Measured: 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)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start17 Aug 2022
- Primary completion31 Dec 2022
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnergyStudies of the same condition, open and under way.
- More trials run by Radicle ScienceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emily K Pauli, PharmD, Principal investigator, Radicle Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502328
- Sponsor's protocol ID
- RADX-22D02
- Status last verified
- Nov 2023
- First submitted
- 8 Aug 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with researchers outside of Radicle Collaborators on this study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05502328
- Acronym / sponsor ID
- RADX-22D02
- Conditions
- Energy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,427 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- 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
| Arm | Type | Receives |
|---|---|---|
| Control 1 | Placebo comparator | Dietary Supplement: Energy Study Product UsageEnergy Product Form 1 - control |
| Control 2 | Placebo comparator | Dietary Supplement: Energy Study Product UsageEnergy Product Form 2 - control |
| Energy Product 1.1 | Experimental | Dietary Supplement: Energy Study Product UsageEnergy Product Form 1 - active product 1 |
| Energy Product 1.2 | Experimental | Dietary Supplement: Energy Study Product UsageEnergy Product Form 1 - active product 2 |
| Energy Product 2.1 | Experimental | Dietary Supplement: Energy Study Product UsageEnergy Product Form 2 - active 1 |
| Energy Product 2.2 | Experimental | Dietary Supplement: Energy Study Product UsageEnergy Product Form 2 - active 2 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy Study Product UsageParticipants will use their Radicle Energy study product as directed for a period of 4 weeks. | Dietary supplement | Control 1, Control 2, Energy Product 1.1, Energy Product 1.2, Energy Product 2.1, Energy Product 2.2 |
Primary outcome
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))
5 secondary outcomes
Change in energy (measure 2)
Time frame: 4 weeks
Change in body weight
Time frame: 4 weeks
Change in appetite
Time frame: 4 weeks
Change in overall quality of life (QOL)
Time frame: 4 weeks
Change in overall well-being
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Radicle Science, IncLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside of Radicle Collaborators on this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily K Pauli, PharmD principal investigator
Radicle Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Study Product Usage in people with Energy, run by Radicle Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in energy (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.