Cannabidiol Oil Effects on Insomnia Severity in a Phase 2 Trial

study phaseA participant's dietary intake pattern should be kept as stable as possible during the treatment phase as there are numerous dietary components other than furanocoumarins that may influence CBD bioavailability\n\nExclusion Criteria:\n\n* Circadian rhythm sleep-wake disorders, sleep related breathing disorders (such as moderate to severe obstructive sleep apnea, central breathing disorders during sleep, or sleep-related stridor that require prompt specific treatment), current delayed sleep phase syndrome where wake up time is regularly later than 8.00 a.m., or a sleep problem fulfilling the ICSD3 criteria of parasomnias\n* Good response to initial treatment for the assessed sleep disorder\n* Use of a benzodiazepine or other sleep medication, unless the patient has tapered off the sleep medication before the moment of inclusion\n* Liver disease or blood levels of transaminases (ALAT, ASAT) above 3x ULN, as long term administration of high doses of CBD may affect (although reversible) liver function\n* History of severe psychiatric comorbidity\n* Increased risk of suicidal thoughts or behaviour\n* History of drug or alcohol abuse\n* Known or suspected hypersensitivity to cannabinoids or to excipients of the formulation of the investigational product - almond oil\n* History of use with CBD oil prepared by pharmacy Clinical Cannabis Care\n* Structural or recreational use of a cannabinoid product \\< 2 months before screening\n* Whether the use of any of the following medications is a reason for exclusion will be at the discretion of the study physicians and delivery pharmacist.\n* drugs with risk of liver injury; the decision of exclusion will be made in consultation with the MS neurologists and the pharmacist that provides the CBD product.\n* drugs with risk of interaction with CBD.

study designLifestyle should be kept as stable as possible.\n* Willing and able to give informed consent\n* Willing and able to fill in a daily digital diary during the treatment phase, to send this to the study nurse or research assistant once a week, and to be contacted by the research assistant minimally twice a week during the treatment phase of the study\n* Willing and able to use the Neurokeys app (thus mobile phone) daily\n* Willing to have blood sampled at the screening visit and have another\n* two blood draws during the treatment phase of the study\n* Willing and able not to drive a car or operate machinery within 8 hours after intake of the investigational product until the end of the treatment phase of the study\n* Willing and able not to do evening/night shift work and not to cross time zones until the completion of the study\n* Willing and able to refrain from excessive use of excessive use of caffeine (\\> 1 cup of coffee or 1 serving of energy drink) and alcohol (\\> 1 serving) in the evening, 6 hours before going to bed\n* Willing and able to refrain from (products of) grapefruit, Seville oranges (used in marmalade), limes and pomelos during the treatment phase of the study\n* Willing and able to refrain from experimenting with timing and type of diet, and beverages during the treatment phase of the study.

randomizedanti-depressant drugs, antidiabetics)\n* Age minimally 18 years at the time of screening\n* Body Mass Index (BMI) \\< 35.0 kg/m2 at the moment of screening\n* Elevated levels of transaminases (ALAT, ASAT) until twice the Upper Limit of Normal (2x ULN) are allowed, as elevation of these levels is a common finding in MS patients\n* No plans to (be involved in) getting pregnant during the trial\n* No breast feeding during the trial\n* A complaint of chronic impairment of sleep quality, leading to a diagnosis of insomnia by an MS neurologist and an experienced somnologist.

controlled"maskingDescription": "It is a double blinded trial in which neither the participants nor the researcher knows when a participant receives cannabidiol or placebo.",

peer reviewedLifestyle should be kept as stable as possible.\n* Willing and able to give informed consent\n* Willing and able to fill in a daily digital diary during the treatment phase, to send this to the study nurse or research assistant once a week, and to be contacted by the research assistant minimally twice a week during the treatment phase of the study\n* Willing and able to use the Neurokeys app (thus mobile phone) daily\n* Willing to have blood sampled at the screening visit and have another\n* two blood draws during the treatment phase of the study\n* Willing and able not to drive a car or operate machinery within 8 hours after intake of the investigational product until the end of the treatment phase of the study\n* Willing and able not to do evening/night shift work and not to cross time zones until the completion of the study\n* Willing and able to refrain from excessive use of excessive use of caffeine (\\> 1 cup of coffee or 1 serving of energy drink) and alcohol (\\> 1 serving) in the evening, 6 hours before going to bed\n* Willing and able to refrain from (products of) grapefruit, Seville oranges (used in marmalade), limes and pomelos during the treatment phase of the study\n* Willing and able to refrain from experimenting with timing and type of diet, and beverages during the treatment phase of the study.

intervention"description": "The Investigational Medicinal Product consists of purified cannabidiol in almond oil.",

comparatorThe investigational placebo consists of almond oil with a subtle blood orange flavor.

primary endpointThe primary outcome is the insomnia severity index (ISI).

findings"timeFrame": "The ISI was administered at baseline and at the end of every treatment block, measuring perceived severity of insomnia over the last two weeks (weeks 2,5,9,13,17)"

limitationsNo results are posted. Planned enrolment and endpoints are not findings.