PainRWE-ACESNCT05003882
Radicle ACES: A Study of Commercially Available CBD Used in the Real-world Setting
An observational study of Pain and Sleep Disturbance, run by Radicle Science at 1 site in United States.
Trial summary
A randomized, open-label study of commercially available, orally ingestible, Cannabidiol (CBD) products used in the real-world setting for pain, sleep, and anxiety. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Sleep Disturbance, Anxiety
- What is being tested?
- Commercially available, orally ingestible CBD product
- Type of treatment
- Pill or oral medicine
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 31 Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (21 yo and older) living in the USA
Who may be able to join
- Participants must be 21 years of age
- Live in the USA
- Endorse symptoms of anxiety, chronic pain, or sleep disturbances as a primary reason for taking a CBD product
- Must have regular access to a computer, mobile device, and/or the internet to complete surveys
Who cannot join
- A person pregnant, trying to become pregnant or breastfeeding
- Anyone diagnosed with liver disease or considered a heavy drinker
- Anyone taking medication that warns against grapefruit consumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label Study of Commercially Available, Orally Ingestible, Cannabidiol (CBD) Products Used in the Real-world Setting for Pain, Sleep, and Anxiety
A randomized, open-label study of commercially available, orally ingestible, Cannabidiol (CBD) products used in the real-world setting for pain, sleep, and anxiety.
Read the detailed description
Radicle ACES is a real-world evidence study that aims to determine the effect of CBD on overall well-being, anxiety, sleep, and pain over a 28-day period in treatment groups compared to a waitlist control group.
- Conditions
- Pain, Sleep Disturbance, Anxiety
- Being tested
- Commercially available, orally ingestible CBD product
- Medical subject headings
- Pain, Parasomnias, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercially available, orally ingestible CBD productOther
botanically-derived CBD extract product
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Commercially available, orally ingestible CBD product A Receives: Other: Commercially available, orally ingestible CBD product | |
| Arm B | Commercially available, orally ingestible CBD product B Receives: Other: Commercially available, orally ingestible CBD product | |
| Arm C | Commercially available, orally ingestible CBD product C Receives: Other: Commercially available, orally ingestible CBD product | |
| Arm D | Commercially available, orally ingestible CBD product D Receives: Other: Commercially available, orally ingestible CBD product | |
| Arm E | Commercially available, orally ingestible CBD product E Receives: Other: Commercially available, orally ingestible CBD product | |
| Arm F | Commercially available, orally ingestible CBD product F Receives: Other: Commercially available, orally ingestible CBD product | |
| Arm G | Commercially available, orally ingestible CBD product G Receives: Other: Commercially available, orally ingestible CBD product | |
| Arm H | Commercially available, orally ingestible CBD product H Receives: Other: Commercially available, orally ingestible CBD product | |
| Arm I | Commercially available, orally ingestible CBD product I Receives: Other: Commercially available, orally ingestible CBD product | |
| Arm J | Commercially available, orally ingestible CBD product J Receives: Other: Commercially available, orally ingestible CBD product | |
| Arm K | Commercially available, orally ingestible CBD product K Receives: Other: Commercially available, orally ingestible CBD product | |
| Arm L | Commercially available, orally ingestible CBD product L Receives: Other: Commercially available, orally ingestible CBD product | |
| Arm M | Commercially available, orally ingestible CBD product M Receives: Other: Commercially available, orally ingestible CBD product | |
| Control | Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Greater increase in overall well-being from baseline
Overall well-being as assessed by KEMP Quality of Life Scale (QOL scale 1-7 where 7 is a better QOL)
Measured: 4 weeks
Improvement in overall well-being from baseline
Overall well-being as assessed by World Health Organization (WHO) 5 Well Being Index (0-5 where 5 is better well-being)
Measured: 4 weeks
Change in overall well-being from baseline
Overall well-being as assessed by Patient Global Impression of Change (PGIC statement selection much improved to much worse)
Measured: 4 weeks
Secondary outcomes (7)
Improvement in sleep from baseline
Sleep as assessed by PROMIS (Patient Reported Outcome Measurement Information System) Sleep Short Form 8B (scale 1-5 where a 5 represents worse sleep)
Measured: 4 weeks
Change in sleep from baseline
Sleep as assessed by PGIC (statement selection much improved to much worse)
Measured: 4 weeks
Change in anxiety from baseline
Anxiety as assessed by PGIC (statement selection much improved to much worse)
Measured: 4 weeks
Less anxiety from baseline
Anxiety as assessed by GAD-7 (scale 0-3 where 3 is greater anxiety)
Measured: 4 weeks
Decrease in anxiety from baseline
Anxiety as assessed by PROMIS Anxiety 4A (scale 1-5 where 5 is greater anxiety)
Measured: 4 weeks
Less pain relative to baseline
Pain as assessed by PEG (scale 1-10 where a higher score is greater pain)
Measured: 4 weeks
Change in pain from baseline
Pain as assessed by PGIC (statement selection much improved to much worse)
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 posted13 Aug 2021
- Study start2 Aug 2021
- Primary completion30 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelsey Laird, PhD, Principal investigator, Radicle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003882
- Sponsor's protocol ID
- Radicle
- Other IDs
- RADX-2021-002
- Acronym
- RWE-ACES
- Status last verified
- Mar 2022
- First submitted
- 23 Jul 2021
- Last updated
- 28 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only aggregated and anonymized data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of Commercially Available, Orally Ingestible, Cannabidiol (CBD) Products Used in the Real-world Setting for Pain, Sleep, and Anxiety
- ClinicalTrials.gov ID
- NCT05003882
- Acronym / sponsor ID
- RWE-ACES / Radicle
- Conditions
- Pain, Sleep Disturbance, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Aug 2021 (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, open-label study of commercially available, orally ingestible, Cannabidiol (CBD) products used in the real-world setting for pain, sleep, and anxiety.
Detailed description
Radicle ACES is a real-world evidence study that aims to determine the effect of CBD on overall well-being, anxiety, sleep, and pain over a 28-day period in treatment groups compared to a waitlist control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product A |
| Arm B | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product B |
| Arm C | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product C |
| Arm D | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product D |
| Arm E | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product E |
| Arm F | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product F |
| Arm G | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product G |
| Arm H | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product H |
| Arm I | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product I |
| Arm J | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product J |
| Arm K | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product K |
| Arm L | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product L |
| Arm M | – | Other: Commercially available, orally ingestible CBD productCommercially available, orally ingestible CBD product M |
| Control | – | –Waitlist control |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (21 yo and older) living in the USA
Key inclusion criteria (4 listed)
- Participants must be 21 years of age
- Live in the USA
- Endorse symptoms of anxiety, chronic pain, or sleep disturbances as a primary reason for taking a CBD product
- Must have regular access to a computer, mobile device, and/or the internet to complete surveys
Key exclusion criteria (3 listed)
- A person pregnant, trying to become pregnant or breastfeeding
- Anyone diagnosed with liver disease or considered a heavy drinker
- Anyone taking medication that warns against grapefruit consumption
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 |
|---|---|---|
| Commercially available, orally ingestible CBD productbotanically-derived CBD extract product | Other | Arm A, Arm B, Arm C, Arm D, Arm E, Arm F, Arm G, Arm H, Arm I, Arm J, Arm K, Arm L, Arm M |
Primary outcome
Greater increase in overall well-being from baseline
Time frame: 4 weeks
Overall well-being as assessed by KEMP Quality of Life Scale (QOL scale 1-7 where 7 is a better QOL)
Improvement in overall well-being from baseline
Time frame: 4 weeks
Overall well-being as assessed by World Health Organization (WHO) 5 Well Being Index (0-5 where 5 is better well-being)
Change in overall well-being from baseline
Time frame: 4 weeks
Overall well-being as assessed by Patient Global Impression of Change (PGIC statement selection much improved to much worse)
7 secondary outcomes
Improvement in sleep from baseline
Time frame: 4 weeks
Change in sleep from baseline
Time frame: 4 weeks
Change in anxiety from baseline
Time frame: 4 weeks
Less anxiety from baseline
Time frame: 4 weeks
Decrease in anxiety from baseline
Time frame: 4 weeks
Less pain relative to baseline
Time frame: 4 weeks
Change in pain from baseline
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 28 Mar 2022.
- Individual participant dataSharing planned: No. only aggregated and anonymized data will be shared.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Kelsey Laird, PhD principal investigator
Radicle Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Sleep Disturbance, 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 4 inclusion and 3 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 28 Mar 2022. 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. 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?
Greater increase in overall well-being from baseline (time frame: 4 weeks). The study lists 3 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 28 Mar 2022.