A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effects of Various Cannabinoids on Sleep Quality
1 other identifier
interventional
332
1 country
1
Brief 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, irritability, and perceived stress).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedFirst Submitted
Initial submission to the registry
August 12, 2026
CompletedFirst Posted
Study publicly available on registry
August 17, 2026
CompletedAugust 19, 2026
August 1, 2026
9 months
August 12, 2026
August 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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)
Daily, Days 1 through 10
Sleep Quality (Consensus Sleep Diary - Core Version)
Daily, Days 1 through 10
Fatigue (Visual Analog Scale-Fatigue [VAS-F])
Daily, Days 1 through 10
Number of Awakenings After Sleep Onset (Consensus Sleep Diary - Core Version)
Daily, Days 1 through 10
Duration of Time Spent Awake After Sleep Onset (Consensus Sleep Diary - Core Version)
Daily, Days 1 through 10
Other Outcomes (7)
Participant-Reported Adverse Events
Daily through Day 10
Early Morning Awakenings
Daily, Days 1 through 10
Depressive Symptoms (Depression Anxiety and Stress Scale-21 [DASS-21])
End of 3-day baseline (Day 3) to final day of the 7-day administration period (Day 10)
- +4 more other outcomes
Study Arms (2)
Difficulty Falling Asleep
EXPERIMENTALIndividuals endorsing difficulty falling asleep will be enrolled in Arm A and receive either (1) Fast Asleep or (2) Fast Asleep Placebo
Difficulty Staying Asleep
EXPERIMENTALIndividuals 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
Interventions
Fast Asleep Gummy
Stay Asleep Gummy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cannabis Science Innovations, LLClead
- Wana Brandscollaborator
Study Sites (1)
Cannabis Science Innovations, LLC
Sarasota, Florida, 34232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcel O Bonn-Miller, PhD
Cannabis Science Innovations, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2026
First Posted
August 17, 2026
Study Start
December 1, 2023
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
August 19, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
The deidentified analytic dataset and analysis scripts are available from the corresponding author upon reasonable request and subject to a data-use agreement.