None listed
Conditions
Brief summary
Insomnia or difficulty falling and/or staying asleep is experienced by 30% of the general population. Medicinal cannabis has been shown to improve sleep quality, length, and associated quality of life. This randomised cross-over double-blind placebo-controlled study of 6 weeks duration aims to assess the tolerability and effectiveness of a medicinal cannabis oil on sleep in adults with insomnia.
Interventions
Randomised double-blind placebo-controlled cross-over trial of 6 weeks duration investigating the effect of a medicinal cannabis oil on sleep in adults with insomnia.
After a run-in period of 1 week, the active treatment group will be allocated to one dose of 0.2-1.5ml per day of THC:CBD (1:1.5) medicinal cannabis oil for 2 weeks to be taken by eyedropper under the tongue in the evening. Participants will be instructed to titrate up by 0.1 ml increments each day, if needed, starting with 0.2ml
Randomised double-blind placebo-controlled cross-over trial of 6 weeks duration investigating the effect of a medicinal cannabis oil on sleep in adults with insomnia. After a run-in period of 1 week, the active treatment group will be allocated to one dose of 0.2-1.5ml per day of THC:CBD (1:1.5) medicinal cannabis oil for 2 weeks to be taken by eyedropper under the tongue in the evening. Participants will be instructed to titrate up by 0.1 ml increments each day, if needed, starting with 0.2ml on day 1, to a maximum of 1.5ml. After the first treatment period of 2 weeks, there is 1 week wash-out period of 1 week, before participants are crossed-over to the alternative treatment for 2 weeks. Participants are to record their dose and any side effects in a daily diary. To help with titration, participants are encouraged to report their daily dose to the research team. Adherence to the intervention will be monitored by participant diary, and unused product return and weighing.
Sponsors
AProf Dr Karin Ried
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Insomnia - measured by insomnia severity index > 7 - having one or more of the following symptoms: - Difficulty falling asleep - Waking up often during the night and/or - Having trouble going back to sleep & Willing not to drive a vehicle during 6 weeks of the study
Exclusion criteria
• Subjects are not pregnant or diagnosed with cancer, unstable cardiac disease, psychotic disorder, schizophrenia, manic episode, seizure disorder, glaucoma, or urinary retention. • Subjects are not shiftworkers. • Subjects are not taking anti-depressants including tricyclic anti-depressant, monoamine oxidase inhibitors, or benzodiazepines. • Subjects known to have hypersensitivity to cannabinoids. • During the study, subjects will be required to avoid taking any other sleep remedies both natural and pharmaceuticals.
Outcome results
None listed