The effect of medicinal cannabis oil on sleep in adults with insomnia: The Cannabis Sleep Study

Not Applicable

Completed

• Conditions: Insomnia; Alternative and Complementary Medicine - Herbal remedies; Neurological - Other neurological disorders

• Registration Number: ACTRN12620000220965
• Lead Sponsor: AProf Dr Karin Ried

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-24
• Study Completion: 2020-12-16
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep Quality measured by questionnaire<br>Composite measure using the Insomnia Severity Index, Stanford Sleepiness Scale, Pittsburgh Sleep Quality Index, and Brief Fatigue Inventory[at 3 and 6 weeks' time points after 2 weeks intervention compared to 0 (enrolment), 1 (baseline/after run-in) and 4 weeks (after wash-out/new baseline) ];Melatonin levels at midnight (12am-2am) measured by Saliva test kit[at 3 and 6 weeks' time points after 2 weeks intervention compared to 0 (enrolment), 1 (baseline/after run-in) and 4 weeks (after wash-out/new baseline) ]

Secondary Outcome Measures

Name	Time	Method
Cortisol levels at midnight (12am-2am) measured by Saliva test kit[at 3 and 6 weeks' time points after 2 weeks intervention compared to 0 (enrolment), 1 (baseline/after run-in) and 4 weeks (after wash-out/new baseline) ];Sleep pattern including heart rate - composite measure measured by wrist activity tracking device[The activity wrist tracker will be worn continuously for 6 weeks post enrolment. Data will be downloaded/recorded at each post-enrolment visit, Analysis will use recorded daily data for 6 weeks. The mean of a 7 day-period will provide comparative data (e.g. mean of daily data of week 1 = baseline data)];mood measured by Bond Lader Mood questionnaire[at 3 and 6 weeks' time points after 2 weeks intervention compared to 0 (enrolment), 1 (baseline/after run-in) and 4 weeks (after wash-out/new baseline) ];Tolerability by in-house questionnaire designed for this and our previous studies; and daily diary[daily during 2x 2 week treatment periods ]