ACTRN12620000220965Completed未知
The effect of medicinal cannabis oil on sleep in adults with insomnia investigated in a randomised double-blind placebo-controlled cross-over trial of 6 weeks duration
AProf Dr Karin Ried0 sites30 target enrollmentStarted: February 24, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 25 Years to 75 Years (—)
- Sex
- All
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.
Investigators
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