SleepNCT05552898
Radicle Sleep: A Study of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes
A study testing Sleep Study Product Usage in people with Sleep, run by Radicle Science at 1 site in United States.
Trial summary
A randomized, blinded, controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall 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
- Sleep
- What is being tested?
- Sleep Study Product Usage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,750 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 26 Aug 2022
- 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 symptoms of sleep disturbance
- Selects sleep disturbance as a primary reason for taking a cannabinoid product
- Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, CBG, CBC, CBN, THC) for the duration of participant engagement (5 weeks)
- Expresses an interest in taking 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radicle™ Sleep: A Randomized, Blinded, Controlled, Direct-to-Consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes
A randomized, blinded, controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes
Read the detailed description
The aim of this study is to determine the safety and effects (if any) of different single agent and combination cannabinoid formulations on self-reported sleep and health in adults (21 years of age and older) that reside in the USA. It is a virtual, direct-to-consumer study that will recruit up to 300 participants per study arm (up to 1800 total). Participants will be followed for 5 weeks as they answer electronic surveys about their health, study product usage, and its impact on their health. There are no in-person visits for this study.
After study completion, study investigators will compare the effects of each cannabinoid study product to melatonin isolate. Study investigators will also run post-hoc analyses (correcting for multiple comparisons) to evaluate the significance of health score changes within individual study product arms, and whether there were significant differences in the effect with the addition of components to comparable cannabinoid study products.
- Conditions
- Sleep
- Being tested
- Sleep Study Product Usage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Study Product UsageDietary supplement
Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Sleep Product Form 1 - control Receives: Dietary Supplement: Sleep Study Product Usage |
| Active Product 1.1 | Experimental | Sleep Product Form 1 - active product 1 Receives: Dietary Supplement: Sleep Study Product Usage |
| Active Product 1.2 | Experimental | Sleep Product Form 1 - active product 2 Receives: Dietary Supplement: Sleep Study Product Usage |
| Active Product 1.3 | Experimental | Sleep Product Form 1 - active product 3 Receives: Dietary Supplement: Sleep Study Product Usage |
| Active Product 1.4 | Experimental | Sleep Product Form 1 - active product 4 Receives: Dietary Supplement: Sleep Study Product Usage |
| Active Product 1.5 | Experimental | Sleep Product Form 1 - active product 5 Receives: Dietary Supplement: Sleep Study Product Usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep disturbance
Sleep disturbance as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance SF 8A (Scoring from 8 to 40, with higher scores translating to greater sleep disturbance. Scores are standardized to US general population [T-score mapping])
Measured: 4 weeks
Secondary outcomes (5)
Change in sleep quantity
Sleep quantity as assessed by average hours of sleep reported per night
Measured: 4 weeks
Change in overall well-being
Change in well-being as assessed by World Health Organization 5 (WHO-5 scale; Scoring from 0 to 25, with higher scores translating to greater well-being)
Measured: 4 weeks
Change in anxiety
Anxiety as assessed by PROMIS Anxiety 4A (Scoring from 4 to 20, with higher scores translating to greater anxiety. Scores are standardized to US general population [T-score mapping)]
Measured: 4 weeks
Change in pain
Pain as assessed by Pain on average, Enjoyment of life, and General activity Score (PEG; scale 0-10 where 0 is no pain)
Measured: 4 weeks
Achievement of minimum clinically important difference (MCID) in sleep disturbance
Odds of achieving a MCID in sleep disturbance as assessed by Sleep disturbance as assessed by PROMIS Sleep Disturbance SF 8A
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 posted23 Sep 2022
- Study start1 Mar 2022
- Primary completion31 May 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- 1,750 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
- NCT05552898
- Sponsor's protocol ID
- RADX-22D01
- Status last verified
- Nov 2023
- First submitted
- 20 Sep 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™ Sleep: A Randomized, Blinded, Controlled, Direct-to-Consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes
- ClinicalTrials.gov ID
- NCT05552898
- Acronym / sponsor ID
- RADX-22D01
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,750 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 23 Sep 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, controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes
Detailed description
The aim of this study is to determine the safety and effects (if any) of different single agent and combination cannabinoid formulations on self-reported sleep and health in adults (21 years of age and older) that reside in the USA. It is a virtual, direct-to-consumer study that will recruit up to 300 participants per study arm (up to 1800 total). Participants will be followed for 5 weeks as they answer electronic surveys about their health, study product usage, and its impact on their health. There are no in-person visits for this study.
After study completion, study investigators will compare the effects of each cannabinoid study product to melatonin isolate. Study investigators will also run post-hoc analyses (correcting for multiple comparisons) to evaluate the significance of health score changes within individual study product arms, and whether there were significant differences in the effect with the addition of components to comparable cannabinoid study products.
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 |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Dietary Supplement: Sleep Study Product UsageSleep Product Form 1 - control |
| Active Product 1.1 | Experimental | Dietary Supplement: Sleep Study Product UsageSleep Product Form 1 - active product 1 |
| Active Product 1.2 | Experimental | Dietary Supplement: Sleep Study Product UsageSleep Product Form 1 - active product 2 |
| Active Product 1.3 | Experimental | Dietary Supplement: Sleep Study Product UsageSleep Product Form 1 - active product 3 |
| Active Product 1.4 | Experimental | Dietary Supplement: Sleep Study Product UsageSleep Product Form 1 - active product 4 |
| Active Product 1.5 | Experimental | Dietary Supplement: Sleep Study Product UsageSleep Product Form 1 - active product 5 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 21 years of age and older
- Resides in the United States
- Endorses symptoms of sleep disturbance
- Selects sleep disturbance as a primary reason for taking a cannabinoid product
- Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, CBG, CBC, CBN, THC) for the duration of participant engagement (5 weeks)
Key exclusion criteria (6 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
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 |
|---|---|---|
| Sleep Study Product UsageParticipants will use their Radicle Sleep study product as directed for a period of 4 weeks. | Dietary supplement | Active Product 1.1, Active Product 1.2, Active Product 1.3, Active Product 1.4, Active Product 1.5, Placebo Control 1 |
Primary outcome
Change in sleep disturbance
Time frame: 4 weeks
Sleep disturbance as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance SF 8A (Scoring from 8 to 40, with higher scores translating to greater sleep disturbance. Scores are standardized to US general population [T-score mapping])
5 secondary outcomes
Change in sleep quantity
Time frame: 4 weeks
Change in overall well-being
Time frame: 4 weeks
Change in anxiety
Time frame: 4 weeks
Change in pain
Time frame: 4 weeks
Achievement of minimum clinically important difference (MCID) in sleep disturbance
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.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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 Sleep Study Product Usage in people with Sleep, 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 6 inclusion and 6 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 sleep disturbance (time frame: 4 weeks). 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.