A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of CBD TPM Capsules in Adults for Use in the Reduction of Insomnia Severity
Insomnia is a common sleep disorder in which a person has difficulty falling asleep or staying asleep or getting good quality sleep. Consequences of insomnia include daytime sleepiness, poor memory function, decline in concentration with negative impacts on social and work activities. Although medical cannabis and cannabis products are widely used worldwide for the management of symptoms associated with insomnia, there is little clinical data available to support the efficacy or utility of CBD in the management of sleep disorders. The proposed study will assess whether nightly doses of 75mg or 150mg of an 8 week period are able to improve patient reported sleep quality when compared to a placebo.
• Males and females aged 18 years or older at the time of informed consent.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Provide a signed and dated patient information and consent form (PICF) for the study.
• Met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder, as follows:
‣ Complained of dissatisfaction with night-time sleep in the form of difficulty getting to sleep, difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep.
⁃ Frequency of the complaint ≥3 times per week.
⁃ Duration of complaint ≥3 months.
⁃ Associated with a complaint of daytime impairment.
• History of subjective Sleep Onset Latency (sSOL) ≥30 minutes on at least 3 nights per week in the previous 4 weeks AND/OR subjective Wake After Sleep Onset (sWASO) ≥30 minutes on at least 3 nights per week in the previous 4 weeks.
• Subject reports a regular time spent in bed, either sleeping or trying to sleep is between 7-10 hours.
• Subjects must have clinical insomnia symptoms as classified by an insomnia severity index (ISI) Score of ≥15.
• Confirmation of current insomnia symptoms as determined from the Sleep Diary completed on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), such that sSOL ≥30 minutes on at least 3 of the 7 nights and/or sWASO ≥30 minutes on at least 3 of the 7 nights.
• Subject reports a typical bedtime, (defined as the time the subject attempts to sleep), between 21:00 and 01:00, and waketime, (defined as the time the subject got out of bed for the day), between 05:00 and 10:00.
⁃ Subject has access to and is able to use a smart phone.
⁃ Female subjects of childbearing potential must be abstinent or agree to use a highly effective method of contraception for 30 days prior to Day 1, during the study, and for at least 28 days following the last dose of Investigational Product (IP). Agrees to refrain from donating eggs (ova, oocytes) (from Day 1 until 28 days following the last dose of IP).
⁃ Male subjects that are not surgically sterile (i.e., vasectomy) must be abstinent or agree to use effective barrier contraception (i.e., condom) from Day 1 and for at least 28 days following the last dose of IP and agrees to refrain from sperm donation (from Day 1 until 28 days following the last dose of IP).