A trial to evaluate an oral medicinal cannabis extract compared with placebo for the treatment of insomnia.

Phase 1

Completed

• Conditions: Insomnia; Neurological - Other neurological disorders

• Registration Number: ACTRN12618000078257
• Lead Sponsor: Zelda Therapeutics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-18
• Study Completion: 2020-03-19
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

a)Has provided a dated informed consent form signed by them; and
b)Is willing to comply with all study procedures and be available for the duration of the study; and
c)Male or female aged 25 – 70 years ; and
d)Presence of chronic insomnia defined as self-reported difficulty initiating (latency to persistent sleep >30 min) and/or maintaining sleep (>30 mins awake, or waking >30 mins before desired waking time)) on three or more nights per week) for at least 3 months; and
e)Insomnia Severity Index score >10

Exclusion Criteria

a)Untreated cardiovascular disease, arrhythmias (other than well controlled atrial fibrillation), hypertension or severe heart failure; or
b)History of allergies particularly to plant-based products containing terpenes, ie flavours and aromatic natural oils for example citrus, mango, lavender, thyme, cedarwood and pine products; or
c)Known hypersensitivity to cannabinoids; or
d)Currently regularly using (greater than or equal to 3 nights/days per week) psychotropic or CNS-active drugs (including cannabis, opioids, benzodiazepines); or
e)Inability to refrain from use of psychotropic or CNS-active drugs (including cannabis, opioids, benzodiazepines) for at least one week prior to and duration of study; or
f)Inability to refrain from use of Cytochrome P450 inhibitors for at least one week prior to and duration of study. Examples include macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (itraconazole, ketoconazole, posaconazole, voriconazole), protease inhibitors (ritonavir, telaprevir, boceprevir), calcium channel blockers (amlopdipine), high cholesterol medication (gemfibrozil), cyclosporine, danazol, tachycardia medication (amiodarone), hypertension medication (verapamil, diltiazem), niacin (vitamin B3 greater than 1g/ day), grapefruit juice; or
g)Untreated metabolic disorders such as diabetes; or
h)Presence of severe depression, severe anxiety or other severe psychopathologic conditions based on self-report or depression scores on the DASS greater than or equal to 21, or anxiety scores on the DASS greater than or equal to 16; or
i)History of suicide attempt or current suicide ideation (response greater than 0 to Question 9 of PHQ-9); or
j)History of seizures or epilepsy; or
k)History of drug or alcohol abuse; or
l)Insomnia associated with sleep apnea (AHI greater than 15 events/hour) or movement disorders such as restless legs, periodic limb movement (PLM) (greater than 30 events/hour or greater than 5 events/hour with associated PLM arousals); or
m)Are currently participating in a formal behavioural therapy program to facilitate sleep; or
n)Current cannabis use (less than 2 months prior); or
o)Pregnancy or lactation; or
p)Inability to refrain from greater than 2 standard drinks/day of alcohol consumption for study duration; or
q)Inability to refrain from greater than 400mg/day of caffeine consumption for study duration; or
r)Shift workers or other workers and athletes who require testing and screening for cannabis products as part of their employment; or
s)Any person required to drive within 10 hours of dose, or those with a self-reported history of falling asleep while driving; or
t)Current delayed sleep phase syndrome where wake up time is regularly later than 8.00am.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety and efficacy as evaluated by adverse event reporting and insomnia symptoms measured by the Insomnia Severity Index questionnaire.[ISI assessments by an Investigator team member on enrolment and at the end of the 14 day baseline period on the morning following night 14, and post treatment periods of investigational product/placebo at the end of each of the 14 day treatment periods, with morning following night 14 (day 15) as the primary endpoint.];safety as evaluated by adverse event reporting.<br>[evaluated throughout the trial by recording of reported adverse events]