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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
332
Fast Asleep Gummy
Stay Asleep Gummy
Stay Asleep-Revision
Cannabis Science Innovations, LLC
Sarasota, Florida, United States
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.
Time frame: End of 3-day baseline (Day 3) to final day of the 7-day administration period (Day 10)
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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Daily, Days 1 through 10
Duration of Time Spent Awake After Sleep Onset (Consensus Sleep Diary - Core Version)
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Same inactive ingredients as study IP
Same inactive ingredients as study IP
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).
Time frame: Daily, Days 1 through 10