SleepNCT05511818
Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes
A study testing Rest Study Product Usage in people with Sleep and Sleep Disturbance, run by Radicle Science at 1 site in United States.
Trial summary
A randomized, blinded, placebo-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, Sleep Disturbance, Sleep Disorder
- What is being tested?
- Rest Study Product Usage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,679 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to 11 Apr 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 better sleep
- Selects sleep 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™ Rest: A Randomized, Blinded, Placebo-controlled, Direct-to-consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes
A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes
Read the detailed description
This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for better sleep, (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
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.
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
- Sleep, Sleep Disturbance, Sleep Disorder
- Being tested
- Rest Study Product Usage
- Medical subject headings
- Parasomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rest Study Product UsageDietary supplement
Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Rest Product Form 1 - control Receives: Dietary Supplement: Rest Study Product Usage |
| Placebo Control 2 | Placebo comparator | Rest Product Form 2 - control Receives: Dietary Supplement: Rest Study Product Usage |
| Placebo Control 3 | Placebo comparator | Rest Product Form 3 - control Receives: Dietary Supplement: Rest Study Product Usage |
| Active Product 1.1 | Experimental | Rest Product Form 1 - active product 1 Receives: Dietary Supplement: Rest Study Product Usage |
| Active Product 1.2 | Experimental | Rest Product Form 1 - active product 2 Receives: Dietary Supplement: Rest Study Product Usage |
| Active Product 1.3 | Experimental | Rest Product Form 1 - active product 3 Receives: Dietary Supplement: Rest Study Product Usage |
| Active Product 1.4 | Experimental | Rest Product Form 1 - active product 4 Receives: Dietary Supplement: Rest Study Product Usage |
| Active Product 2.1 | Experimental | Rest Product Form 2 - active product 1 Receives: Dietary Supplement: Rest Study Product Usage |
| Active Product 2.2 | Experimental | Rest Product Form 2 - active product 2 Receives: Dietary Supplement: Rest Study Product Usage |
| Active Product 3.1 | Experimental | Rest Product Form 3 - active product 1 Receives: Dietary Supplement: Rest Study Product Usage |
| Active Product 3.2 | Experimental | Rest Product Form 3 - active product 2 Receives: Dietary Supplement: Rest Study Product Usage |
| Placebo Control 4 | Placebo comparator | Rest Product Form 4 - control Receives: Dietary Supplement: Rest Study Product Usage |
| Active Product 4 | Experimental | Rest Product Form 4 - active product 1 Receives: Dietary Supplement: Rest Study Product Usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep disturbance
Mean difference in sleep disturbance score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)
Measured: 4 weeks
Secondary outcomes (7)
Change in overall well-being
Mean difference in well-being score as assessed by World Health Organization 5 (WHO 5; scale 0-25; with 0 representing the worst imaginable well-being and 25 representing the best imaginable well-being)
Measured: 4 weeks
Change in overall quality of life (QOL)
Mean difference in QOL score as assessed by Kemp QOL (scale 1-7; with 1 representing very poor QOL and 7 representing excellent QOL)
Measured: 4 weeks
Change in anxiety
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Measured: 4 weeks
Change in pain
Mean difference in pain score as assessed by the Pain on average, Enjoyment of life, and General activity score (PEG; scale 0-10; with 0 representing no pain and 10 representing the worst pain imaginable that completely interferes with enjoyment of life and general activities)
Measured: 4 weeks
Change in stress
Mean difference in stress score as assessed by PROMIS Stress 4A (scale 4-20; where higher scores correspond to more severe stress)
Measured: 4 weeks
Change in fatigue
Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)
Measured: 4 weeks
Minimal clinically important difference (MCID) in sleep disturbance
Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)
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 Aug 2022
- Study start12 Sep 2022
- Primary completion31 Dec 2022
- Study completion11 Apr 2023
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 at birth then randomized to one of the study arms
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,679 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
- NCT05511818
- Sponsor's protocol ID
- RADX-22D03
- Status last verified
- Nov 2023
- First submitted
- 10 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™ Rest: A Randomized, Blinded, Placebo-controlled, Direct-to-consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes
- ClinicalTrials.gov ID
- NCT05511818
- Acronym / sponsor ID
- RADX-22D03
- Conditions
- Sleep, Sleep Disturbance, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,679 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 23 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, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes
Detailed description
This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for better sleep, (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
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.
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
- 13
- Model description
- Participants will be stratified based on gender at birth then randomized to one of the study arms
| Arm | Type | Receives |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Dietary Supplement: Rest Study Product UsageRest Product Form 1 - control |
| Placebo Control 2 | Placebo comparator | Dietary Supplement: Rest Study Product UsageRest Product Form 2 - control |
| Placebo Control 3 | Placebo comparator | Dietary Supplement: Rest Study Product UsageRest Product Form 3 - control |
| Active Product 1.1 | Experimental | Dietary Supplement: Rest Study Product UsageRest Product Form 1 - active product 1 |
| Active Product 1.2 | Experimental | Dietary Supplement: Rest Study Product UsageRest Product Form 1 - active product 2 |
| Active Product 1.3 | Experimental | Dietary Supplement: Rest Study Product UsageRest Product Form 1 - active product 3 |
| Active Product 1.4 | Experimental | Dietary Supplement: Rest Study Product UsageRest Product Form 1 - active product 4 |
| Active Product 2.1 | Experimental | Dietary Supplement: Rest Study Product UsageRest Product Form 2 - active product 1 |
| Active Product 2.2 | Experimental | Dietary Supplement: Rest Study Product UsageRest Product Form 2 - active product 2 |
| Active Product 3.1 | Experimental | Dietary Supplement: Rest Study Product UsageRest Product Form 3 - active product 1 |
| Active Product 3.2 | Experimental | Dietary Supplement: Rest Study Product UsageRest Product Form 3 - active product 2 |
| Placebo Control 4 | Placebo comparator | Dietary Supplement: Rest Study Product UsageRest Product Form 4 - control |
| Active Product 4 | Experimental | Dietary Supplement: Rest Study Product UsageRest Product Form 4 - active product 1 |
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 a desire for better sleep
- Selects sleep 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 |
|---|---|---|
| Rest Study Product UsageParticipants will use their Radicle Rest 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 2.1, Active Product 2.2, Active Product 3.1, Active Product 3.2, Active Product 4, Placebo Control 1, Placebo Control 2, Placebo Control 3, Placebo Control 4 |
Primary outcome
Change in sleep disturbance
Time frame: 4 weeks
Mean difference in sleep disturbance score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)
7 secondary outcomes
Change in overall well-being
Time frame: 4 weeks
Change in overall quality of life (QOL)
Time frame: 4 weeks
Change in anxiety
Time frame: 4 weeks
Change in pain
Time frame: 4 weeks
Change in stress
Time frame: 4 weeks
Change in fatigue
Time frame: 4 weeks
Minimal 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.
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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 Rest Study Product Usage in people with Sleep 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 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.