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
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Insomnia
- Sponsor
- Avecho Biotechnology
- Enrollment
- 519
- Locations
- 5
- Primary Endpoint
- Mean change from study baseline of insomnia severity index (ISI) score at 8 weeks
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Significant insomnia caused during another sleep-wake disorder, including narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia, restless leg syndrome, or an exclusionary score on the Sleep Disorders Screening Battery, or Epworth Sleepiness Scale score as follows:
- •STOP-Bang score ≥
- •International Restless Legs Scale score ≥
- •Epworth Sleepiness Scale score \>15 (scores of 11-15 required excessive daytime sleepiness to be recorded in subject's medical history).
- •Reports symptoms potentially related to narcolepsy that in the clinical opinion of the Investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy.
- •Reports a history of sleep-related violent behavior, or sleep driving, or any other complex sleep-related behavior, e.g., making phone calls, or preparing and eating food while asleep.
- •Beck Depression Inventory - (BDI II) score \>19 at Screening.
- •Beck Anxiety Inventory \>15 at Screening.
- •Habitually napped more than three times per week.
- •Current or recent cannabis use, within 30 days of consent, and throughout the study.
Arms & Interventions
Placebo
Nightly dose of two placebo capsules
Intervention: Placebo
75mg CBD
Nightly dose of one 75mg CBD capsule and one placebo capsule
Intervention: Cannabidiol (CBD) Capsule 75mg
75mg CBD
Nightly dose of one 75mg CBD capsule and one placebo capsule
Intervention: Placebo
150mg CBD
Nightly dose of two 75mg CBD capsules
Intervention: Cannabidiol (CBD) Capsule 75mg
Outcomes
Primary Outcomes
Mean change from study baseline of insomnia severity index (ISI) score at 8 weeks
Time Frame: 8 weeks
The insomnia severity index (ISI) is a seven-item self-report questionnaire used to assess the severity of the insomnia disorder. Total score ranges from 0-28. 0 - 7 No clinically significant insomnia. 8 - 14 Subthreshold insomnia. 15 - 21 Clinical insomnia (moderate severity) 22 - 28 Clinical insomnia (severe)
Mean change from study baseline in subject sleep efficiency (sSE) at 8 weeks
Time Frame: 8 weeks