Sleep DisturbanceNCT07769164
A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effects of Various Cannabinoids on Sleep Quality
A study testing 2 mg THC + 2 mg CBN + 2 mg CBG + 10 mg CBD + 1 mg Melatonin, 10 mg THC + 5 mg CBN + 5 mg CBG + 20 mg CBD and 10 mg THC + 20 mg CBN + 5 mg CBG in people with Sleep Disturbance and Sleep Quality, run by Cannabis Science Innovations, LLC at 1 site in United States.
Trial summary
This double-blind, randomized, placebo-controlled study will assess the safety and effects of different combinations of CBN, CBG, and THC, with and without CBD and melatonin, for enhancing sleep quality, other factors related to sleep, daytime fatigue, and mood symptoms related to sleep (i.e., depression, anxiety… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Sleep Quality
- What is being tested?
- 2 mg THC + 2 mg CBN + 2 mg CBG + 10 mg CBD + 1 mg Melatonin, 10 mg THC + 5 mg CBN + 5 mg CBG + 20 mg CBD and 10 mg THC + 20 mg CBN + 5 mg CBG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 31 Aug 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for enrollment into the study:
- Person is between 21 and 55-years-old (inclusive).
- Person has a BMI between 18 and 39 kg/m2 (inclusive).
- Person rates past-week sleep quality on a 1 (very good) to 5 (very poor) rating scale as poor (4) or very poor (5).
- For Arm A: Person rates past-week frequency of difficulty falling asleep on a 1 (not at all) to 5 (very much) rating scale as quite a bit (4) or very much (5).
- For Arm B: Person rates past-week frequency of trouble staying asleep on a 1 (never) to 5 (always) rating scales as often (4) or always (5).
- Person is willing and able to provide informed consent.
- Person agrees to abide by all study restrictions and comply with all study procedures.
Who cannot join
- Participants meeting any of the following criteria will not be eligible for participation in the study:
- Person has a known history of significant allergic condition or significant hypersensitivity to cannabis, cannabinoid medications, hemp products, melatonin, or excipients of the IP.
- Person has been exposed to any investigational drug or device < 30 days prior to screening or plans to use an investigational drug or device during the study.
- Person has had a change in allowable medication, tobacco, alcohol, caffeine, cannabis (including individual or combination cannabinoid products), or supplement dose or regimen within 30 days of screening or has any plans to change dose or regimen during the study.
- Person has used tetrahydrocannabinol (THC; e.g., delta-9, delta-8) or cannabinol (CBN)-containing product more than four times per week during the prior 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.
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- Person has used illicit substances (e.g., amphetamine, cocaine, methamphetamine, MDMA, LSD, ketamine, heroin, psilocybin, salvia, prescription medications not prescribed to the person) in the past 30 days or plans to use them during the study.
- Person is currently using products or medications that may interact or overlap 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, Epidiolex, sleep supplements or prescription sleep aids.
- 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 works night or swing shift.
- Person has a personal or family history (first-degree relative) of a psychotic disorder and/or schizophrenia.
- 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 is currently pregnant, breastfeeding, or planning to become pregnant within 30 days of the study.
- Woman of childbearing potential, unless she has not engaged in vaginal intercourse, or she has used effective contraception when doing so (for example, double barrier), 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, double barrier) 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, double barrier) 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.
United States1 site
Cannabis Science Innovations, LLC
Sarasota, Florida, 34232
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of Various Cannabinoids on Sleep Quality
This double-blind, randomized, placebo-controlled study will assess the safety and effects of different combinations of CBN, CBG, and THC, with and without CBD and melatonin, for enhancing sleep quality, other factors related to sleep, daytime fatigue, and mood symptoms related to sleep (i.e., depression, anxiety, irritability, and perceived stress).
Read the detailed description
This is a double-blind, randomized, placebo-controlled study assessing the effects of different combinations of cannabinol (CBN), cannabigerol (CBG), tetrahydrocannabinol(THC), with and without cannabidiol (CBD) and melatonin, on sleep parameters and related outcomes (i.e., depression, anxiety, irritability, and perceived stress). A total of up to 375 eligible adults (aged 21-55) will complete the study. Individuals interested in this study will provide written, informed consent to participate and complete an online screening visit. People deemed ineligible during the Screening Phase will be informed they are not eligible and thanked for their time. People who appear eligible after completing the Screening Phase will complete the full Informed Consent Form. People who meet inclusion/exclusion criteria will be enrolled into one of two arms based on their responses to the sleep disturbance questionnaire completed at screening. If they endorse difficulty falling asleep, they will be enrolled in Arm A. If they endorse difficulty staying asleep, they will be enrolled in Arm B. If they endorse both symptoms, the more frequently occurring symptom will be used to enroll them into the respective arm. They will be randomized to receive active study IP or placebo in each arm.
- Conditions
- Sleep Disturbance, Sleep Quality
- Being tested
- 2 mg THC + 2 mg CBN + 2 mg CBG + 10 mg CBD + 1 mg Melatonin, 10 mg THC + 5 mg CBN + 5 mg CBG + 20 mg CBD, 10 mg THC + 20 mg CBN + 5 mg CBG, Stay Asleep Placebo, Fast Asleep Placebo
- Keywords
- Cannabidiol, Cannabinol, Cannabigerol, Tetrahydrocannabinol, Melatonin, Sleep, Dietary Supplement
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 mg THC + 2 mg CBN + 2 mg CBG + 10 mg CBD + 1 mg MelatoninDietary supplement
Fast Asleep Gummy
10 mg THC + 5 mg CBN + 5 mg CBG + 20 mg CBDDietary supplement
Stay Asleep Gummy
10 mg THC + 20 mg CBN + 5 mg CBGDietary supplement
Stay Asleep-Revision
Stay Asleep PlaceboDietary supplement
Same inactive ingredients as study IP
Fast Asleep PlaceboDietary supplement
Same inactive ingredients as study IP
| Study group | Role | What they receive |
|---|---|---|
| Difficulty Falling Asleep | Experimental | Individuals endorsing difficulty falling asleep will be enrolled in Arm A and receive either (1) Fast Asleep or (2) Fast Asleep Placebo Receives: Dietary Supplement: 2 mg THC + 2 mg CBN + 2 mg CBG + 10 mg CBD + 1 mg Melatonin; Dietary Supplement: Fast Asleep Placebo |
| Difficulty Staying Asleep | Experimental | Individuals reporting difficulty staying asleep will be enrolled in Arm B and receive either (1) Stay Asleep; (2) Stay Asleep- Revision; or (3) Stay Asleep Placebo Receives: Dietary Supplement: 10 mg THC + 5 mg CBN + 5 mg CBG + 20 mg CBD; Dietary Supplement: 10 mg THC + 20 mg CBN + 5 mg CBG; Dietary Supplement: Stay Asleep Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Disturbance T-Score (Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b [PROMIS-SD])
For both Arm A and Arm B: Self-reported sleep disturbance (measured with the PROMIS-SD). Scores range from 28.9-76.5, with higher scores representing greater sleep disturbance.
Measured: End of 3-day baseline (Day 3) to final day of the 7-day administration period (Day 10)
Secondary outcomes (5)
Sleep Onset Latency (Consensus Sleep Diary - Core Version)
For Arm A Only: Self-reported latency to sleep onset (in minutes; measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Measured: Daily, Days 1 through 10
Sleep Quality (Consensus Sleep Diary - Core Version)
For both Arm A and Arm B: Self-reported sleep quality (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning). Scores range from 0-4, with higher scores representing greater sleep quality.
Measured: Daily, Days 1 through 10
Fatigue (Visual Analog Scale-Fatigue [VAS-F])
For both Arm A and Arm B: Self-reported daytime fatigue (measured with the VAS-F completed before bedtime each day). Scores range from 0-100, with higher scores representing greater fatigue.
Measured: Daily, Days 1 through 10
Number of Awakenings After Sleep Onset (Consensus Sleep Diary - Core Version)
For Arm B Only: Self-reported number of awakenings after sleep onset (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Measured: Daily, Days 1 through 10
Duration of Time Spent Awake After Sleep Onset (Consensus Sleep Diary - Core Version)
For Arm B Only: Self-reported duration of time spent awake after sleep onset (in minutes; measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning).
Measured: Daily, Days 1 through 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Dec 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cannabis Science Innovations, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wana Brands
- Responsible party
- Sponsor
- Investigators
- Marcel O Bonn-Miller, PhD, Principal investigator, Cannabis Science Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769164
- Sponsor's protocol ID
- 11020-MOBonnMiller
- Other IDs
- 11020-MOBonnMiller
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The deidentified analytic dataset and analysis scripts are available from the corresponding author upon reasonable request and subject to a data-use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study of Various Cannabinoids on Sleep Quality
- ClinicalTrials.gov ID
- NCT07769164
- Acronym / sponsor ID
- 11020-MOBonnMiller
- Conditions
- Sleep Disturbance, Sleep Quality
- Keywords
- Cannabidiol, Cannabinol, Cannabigerol, Tetrahydrocannabinol, Melatonin, Sleep, Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Cannabis Science Innovations, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Wana Brands
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 17 Aug 2026 (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 double-blind, randomized, placebo-controlled study will assess the safety and effects of different combinations of CBN, CBG, and THC, with and without CBD and melatonin, for enhancing sleep quality, other factors related to sleep, daytime fatigue, and mood symptoms related to sleep (i.e., depression, anxiety, irritability, and perceived stress).
Detailed description
This is a double-blind, randomized, placebo-controlled study assessing the effects of different combinations of cannabinol (CBN), cannabigerol (CBG), tetrahydrocannabinol(THC), with and without cannabidiol (CBD) and melatonin, on sleep parameters and related outcomes (i.e., depression, anxiety, irritability, and perceived stress). A total of up to 375 eligible adults (aged 21-55) will complete the study. Individuals interested in this study will provide written, informed consent to participate and complete an online screening visit. People deemed ineligible during the Screening Phase will be informed they are not eligible and thanked for their time. People who appear eligible after completing the Screening Phase will complete the full Informed Consent Form. People who meet inclusion/exclusion criteria will be enrolled into one of two arms based on their responses to the sleep disturbance questionnaire completed at screening. If they endorse difficulty falling asleep, they will be enrolled in Arm A. If they endorse difficulty staying asleep, they will be enrolled in Arm B. If they endorse both symptoms, the more frequently occurring symptom will be used to enroll them into the respective arm. They will be randomized to receive active study IP or placebo in each arm.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difficulty Falling Asleep | Experimental | Dietary Supplement: 2 mg THC + 2 mg CBN + 2 mg CBG + 10 mg CBD + 1 mg Melatonin, Dietary Supplement: Fast Asleep PlaceboIndividuals endorsing difficulty falling asleep will be enrolled in Arm A and receive either (1) Fast Asleep or (2) Fast Asleep Placebo |
| Difficulty Staying Asleep | Experimental | Dietary Supplement: 10 mg THC + 5 mg CBN + 5 mg CBG + 20 mg CBD, Dietary Supplement: 10 mg THC + 20 mg CBN + 5 mg CBG, Dietary Supplement: Stay Asleep PlaceboIndividuals reporting difficulty staying asleep will be enrolled in Arm B and receive either (1) Stay Asleep; (2) Stay Asleep- Revision; or (3) Stay Asleep Placebo |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants must meet all of the following criteria to be eligible for enrollment into the study:
- Person is between 21 and 55-years-old (inclusive).
- Person has a BMI between 18 and 39 kg/m2 (inclusive).
- Person rates past-week sleep quality on a 1 (very good) to 5 (very poor) rating scale as poor (4) or very poor (5).
- For Arm A: Person rates past-week frequency of difficulty falling asleep on a 1 (not at all) to 5 (very much) rating scale as quite a bit (4) or very much (5).
Key exclusion criteria (18 listed)
- Participants meeting any of the following criteria will not be eligible for participation in the study:
- Person has a known history of significant allergic condition or significant hypersensitivity to cannabis, cannabinoid medications, hemp products, melatonin, or excipients of the IP.
- Person has been exposed to any investigational drug or device < 30 days prior to screening or plans to use an investigational drug or device during the study.
- Person has had a change in allowable medication, tobacco, alcohol, caffeine, cannabis (including individual or combination cannabinoid products), or supplement dose or regimen within 30 days of screening or has any plans to change dose or regimen during the study.
- Person has used tetrahydrocannabinol (THC; e.g., delta-9, delta-8) or cannabinol (CBN)-containing product more than four times per week during the prior 30 days of screening or during the study.
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 |
|---|---|---|
| 2 mg THC + 2 mg CBN + 2 mg CBG + 10 mg CBD + 1 mg MelatoninFast Asleep Gummy | Dietary supplement | Difficulty Falling Asleep |
| 10 mg THC + 5 mg CBN + 5 mg CBG + 20 mg CBDStay Asleep Gummy | Dietary supplement | Difficulty Staying Asleep |
| 10 mg THC + 20 mg CBN + 5 mg CBGStay Asleep-Revision | Dietary supplement | Difficulty Staying Asleep |
| Stay Asleep PlaceboSame inactive ingredients as study IP | Dietary supplement | Difficulty Staying Asleep |
| Fast Asleep PlaceboSame inactive ingredients as study IP | Dietary supplement | Difficulty Falling Asleep |
Primary outcome
Sleep Disturbance T-Score (Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b [PROMIS-SD])
Time frame: End of 3-day baseline (Day 3) to final day of the 7-day administration period (Day 10)
For both Arm A and Arm B: Self-reported sleep disturbance (measured with the PROMIS-SD). Scores range from 28.9-76.5, with higher scores representing greater sleep disturbance.
5 secondary outcomes
Sleep Onset Latency (Consensus Sleep Diary - Core Version)
Time frame: Daily, Days 1 through 10
Sleep Quality (Consensus Sleep Diary - Core Version)
Time frame: Daily, Days 1 through 10
Fatigue (Visual Analog Scale-Fatigue [VAS-F])
Time frame: Daily, Days 1 through 10
Number of Awakenings After Sleep Onset (Consensus Sleep Diary - Core Version)
Time frame: Daily, Days 1 through 10
Duration of Time Spent Awake After Sleep Onset (Consensus Sleep Diary - Core Version)
Time frame: Daily, Days 1 through 10
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 19 Aug 2026.
- Individual participant dataSharing planned: Yes. The deidentified analytic dataset and analysis scripts are available from the corresponding author upon reasonable request and subject to a data-use agreement.
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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.
Marcel O Bonn-Miller, PhD principal investigator
Cannabis Science Innovations, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 mg THC + 2 mg CBN + 2 mg CBG + 10 mg CBD + 1 mg Melatonin, 10 mg THC + 5 mg CBN + 5 mg CBG + 20 mg CBD and 10 mg THC + 20 mg CBN + 5 mg CBG in people with Sleep Disturbance and Sleep Quality, run by Cannabis Science Innovations, LLC 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 8 inclusion and 18 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 19 Aug 2026. 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?
Sleep Disturbance T-Score (Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b [PROMIS-SD]) (time frame: End of 3-day baseline (Day 3) to final day of the 7-day administration period (Day 10)). 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 19 Aug 2026.