Healthy AdultsPhase 1/2NCT05839964
A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effects of CBN With and Without CBD on Sleep Quality
A Phase 1/2 study testing CBN and CBD in people with Healthy Adults, run by Canopy Growth Corporation at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, study to assess the safety and effects of CHI-560, CHI-563, CHI-564, \& CHI-565 versus placebo on sleep quality in healthy adult participants ages 18-55 years. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- CBN and CBD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 6 Dec 2022
- Phase
- Phase 1/2
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Person is between 18 and 55-years-old (inclusive).
- Person has a BMI between 18 and 35 kg/m2 (inclusive).
- Person is willing and able to provide informed consent.
- Woman of childbearing potential must not be pregnant or currently breastfeeding.
- Person agrees to abide by all study restrictions and comply with all study procedures.
- Person rates past-week sleep quality on a 1 (very poor) to 5 (very good) rating scale as poor (2) or very poor (1).
Who cannot join
- Person has a known history of significant allergic condition, significant hypersensitivity to the IP, or allergic reaction to cannabis, cannabinoid medications, hemp products, or excipients of the IP.
- Person has been exposed to any investigational drug or device < 30 days prior to screening or plans to take an investigational drug in the near future (within 30 days).
- Person has had a change in allowable medication, caffeine, tobacco, alcohol, supplement, or other drug use dose or regimen within 30 days of screening or has any plans to change dose or regimen during the course of the study.
- Person has used cannabis, cannabinoid analogue (e.g., dronabinol, nabilone), and/or any CBD- or delta-9-tetrahydrocannabinol (THC)-containing product within 30 days of screening or during the study.
- Person has history of use of any synthetic cannabinoid receptor agonist (e.g., spice, K2) within the past year.
- Person is currently using products or medications that may interact with one or more of the ingredients in the IP, including the following drugs or supplements: warfarin, clobazam, valproic acid, phenobarbital, mechanistic target of rapamycin [mTOR] inhibitors, oral tacrolimus, St. John's wort, and Epidiolex.
Show all 16Show fewer
- Person has a positive screen (i.e., exceeds cut-point score) for any of the following sleep disorders on the Sleep Disorders Symptom Checklist-17 (SDS-CL-17): narcolepsy, obstructive sleep apnea, restless legs syndrome.
- Person has a personal or family history (first-degree relative) of a psychotic disorder and/or schizophrenia.
- Person endorses current suicidal intent as indexed via items 4 and 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Person has an acute or progressive disease or disorder that is likely to interfere with the objectives of the study, or the ability to adhere to protocol requirements.
- Person has a history of cardiovascular disease.
- Woman of childbearing potential, unless she has not engaged in vaginal intercourse or she has used effective contraception when doing so (for example, oral contraception, double barrier, intra-uterine device) for at least 30 days prior to the study.
- Woman of childbearing potential, unless willing to ensure that she or her partner use effective contraception (for example, oral contraception, double barrier, intra-uterine device) during the study and for 30 days thereafter (however, a male condom should not be used in conjunction with a female condom).
- Man whose partner is of childbearing potential, unless willing to ensure that he or his partner use effective contraception (for example, oral contraception, double barrier, intra-uterine device) during the study and for 30 days thereafter (however, a male condom should not be used in conjunction with a female condom).
- Person has history of diagnosis related to hepatic function and/or significantly impaired hepatic function (alanine aminotransferase [ALT] >5 ⋅ upper limit of normal [ULN] or total bilirubin [TBL] >2 ⋅ ULN) OR the ALT or aspartate aminotransferase (AST) >3 ⋅ ULN and TBL >2 ⋅ ULN (or international normalized ratio [INR] >1.5).
- Person demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, double-blind, placebo-controlled, study to assess the safety and effects of CHI-560, CHI-563, CHI-564, \& CHI-565 versus placebo on sleep quality in healthy adult participants ages 18-55 years.
- Conditions
- Healthy Adults
- Being tested
- CBN and CBD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBN and CBDDietary supplement
CBN and CBD in Gummy Format
| Study group | Role | What they receive |
|---|---|---|
| CHI-560: Total daily dose: 20 mg CBN | Active comparator | 2 units (i.e., 2 gummies). Each gummy: 10 mg CBN Receives: Dietary Supplement: CBN and CBD |
| CHI-563: Total daily dose: 20 mg CBN + 10 mg CBD | Active comparator | 2 units (i.e., 2 gummies). Each gummy: 10 mg CBN + 5 mg CBD Receives: Dietary Supplement: CBN and CBD |
| CHI-564: Total daily dose: 20 mg CBN + 20 mg CBD | Active comparator | 2 units (i.e., 2 gummies). Each gummy: 10 mg CBN + 10 mg CBD Receives: Dietary Supplement: CBN and CBD |
| CHI-565: Total daily dose: 20 mg CBN + 100 mg CBD | Active comparator | 2 units (i.e., 2 gummies). Each gummy: 10 mg CBN + 50 mg CBD Receives: Dietary Supplement: CBN and CBD |
| CHI-660: Placebo | Placebo comparator | 2 units (i.e., 2 gummies). Each gummy: Placebo Receives: Dietary Supplement: CBN and CBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median sleep quality rating during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Median sleep quality rating during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Measured: Days 1-7
Secondary outcomes (5)
Mean latency to sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Mean latency to sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Measured: Days 1-7
Number of awakenings after sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Number of awakenings after sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Measured: Days 1-7
Mean duration of time spent awake after sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Mean duration of time spent awake after sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Measured: Days 1-7
Sleep disturbance during the IP administration phase (measured with the PROMIS completed at the end of the IP administration phase).
Sleep disturbance during the IP administration phase (measured with the PROMIS completed at the end of the IP administration phase).
Measured: Days 1-7
Mean daytime fatigue during the IP administration phase (measured with the VAS-F completed approximately 90 minutes before bedtime each day).
Mean daytime fatigue during the IP administration phase (measured with the VAS-F completed approximately 90 minutes before bedtime each day).
Measured: Days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start16 May 2022
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canopy Growth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew T Feldner, PhD, Principal investigator, Canopy Growth Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839964
- Sponsor's protocol ID
- 710US-1501
- Status last verified
- Apr 2023
- First submitted
- 21 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonn-Miller MO, Feldner MT, Bynion TM, Eglit GML, Brunstetter M, Kalaba M, Zvorsky I, Peters EN, Hennesy M. A double-blind, randomized, placebo-controlled study of the safety and effects of CBN with and without CBD on sleep quality. Exp Clin Psychopharmacol. 2024 Jun;32(3):277-284. doi: 10.1037/pha0000682. Epub 2023 Oct 5.
PubMed 37796540
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effects of CBN With and Without CBD on Sleep Quality
- ClinicalTrials.gov ID
- NCT05839964
- Acronym / sponsor ID
- 710US-1501
- Conditions
- Healthy Adults
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Canopy Growth CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 3 May 2023 (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.
This is a randomized, double-blind, placebo-controlled, study to assess the safety and effects of CHI-560, CHI-563, CHI-564, \& CHI-565 versus placebo on sleep quality in healthy adult participants ages 18-55 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CHI-560: Total daily dose: 20 mg CBN | Active comparator | Dietary Supplement: CBN and CBD2 units (i.e., 2 gummies). Each gummy: 10 mg CBN |
| CHI-563: Total daily dose: 20 mg CBN + 10 mg CBD | Active comparator | Dietary Supplement: CBN and CBD2 units (i.e., 2 gummies). Each gummy: 10 mg CBN + 5 mg CBD |
| CHI-564: Total daily dose: 20 mg CBN + 20 mg CBD | Active comparator | Dietary Supplement: CBN and CBD2 units (i.e., 2 gummies). Each gummy: 10 mg CBN + 10 mg CBD |
| CHI-565: Total daily dose: 20 mg CBN + 100 mg CBD | Active comparator | Dietary Supplement: CBN and CBD2 units (i.e., 2 gummies). Each gummy: 10 mg CBN + 50 mg CBD |
| CHI-660: Placebo | Placebo comparator | Dietary Supplement: CBN and CBD2 units (i.e., 2 gummies). Each gummy: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Person is between 18 and 55-years-old (inclusive).
- Person has a BMI between 18 and 35 kg/m2 (inclusive).
- Person is willing and able to provide informed consent.
- Woman of childbearing potential must not be pregnant or currently breastfeeding.
- Person agrees to abide by all study restrictions and comply with all study procedures.
Key exclusion criteria (16 listed)
- Person has a known history of significant allergic condition, significant hypersensitivity to the IP, or allergic reaction to cannabis, cannabinoid medications, hemp products, or excipients of the IP.
- Person has been exposed to any investigational drug or device < 30 days prior to screening or plans to take an investigational drug in the near future (within 30 days).
- Person has had a change in allowable medication, caffeine, tobacco, alcohol, supplement, or other drug use dose or regimen within 30 days of screening or has any plans to change dose or regimen during the course of the study.
- Person has used cannabis, cannabinoid analogue (e.g., dronabinol, nabilone), and/or any CBD- or delta-9-tetrahydrocannabinol (THC)-containing product within 30 days of screening or during the study.
- Person has history of use of any synthetic cannabinoid receptor agonist (e.g., spice, K2) within the past year.
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 |
|---|---|---|
| CBN and CBDCBN and CBD in Gummy Format | Dietary supplement | CHI-560: Total daily dose: 20 mg CBN, CHI-563: Total daily dose: 20 mg CBN + 10 mg CBD, CHI-564: Total daily dose: 20 mg CBN + 20 mg CBD, CHI-565: Total daily dose: 20 mg CBN + 100 mg CBD, CHI-660: Placebo |
Primary outcome
Median sleep quality rating during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Time frame: Days 1-7
Median sleep quality rating during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
5 secondary outcomes
Mean latency to sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Time frame: Days 1-7
Number of awakenings after sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Time frame: Days 1-7
Mean duration of time spent awake after sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Time frame: Days 1-7
Sleep disturbance during the IP administration phase (measured with the PROMIS completed at the end of the IP administration phase).
Time frame: Days 1-7
Mean daytime fatigue during the IP administration phase (measured with the VAS-F completed approximately 90 minutes before bedtime each day).
Time frame: Days 1-7
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 3 May 2023.
- Derived from this study: PubMed 37796540Bonn-Miller MO, Feldner MT, Bynion TM, Eglit GML, Brunstetter M, Kalaba M, Zvorsky I, Peters EN, Hennesy M. A double-blind, randomized, placebo-controlled study of the safety and effects of CBN with and without CBD on sleep quality. Exp Clin Psychopharmacol. 2024 Jun;32(3):277-284. doi: 10.1037/pha0000682. Epub 2023 Oct 5.
- Individual participant dataSharing planned: No
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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.
Matthew T Feldner, PhD principal investigator
Canopy Growth Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CBN and CBD in people with Healthy Adults, run by Canopy Growth Corporation 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 16 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 3 May 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Median sleep quality rating during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning). (time frame: Days 1-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05839964, which also lists 1 linked publication.
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 3 May 2023.