CompletedPhase 1ACTRN12618000078257

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

A study to evaluate the safety and efficacy of sublingual cannabinoid based medicine extract compared with placebo for the treatment of Insomnia

Sponsor

Zelda Therapeutics Limited

Enrollment

24 participants

Start Date

Jun 6, 2019

Study Type

Interventional

Conditions

Insomnia

Summary

Insomnia is the most common sleep disorder. Australian surveys have shown that 13-33% of the adult population have regular difficulty getting to sleep or staying asleep. Previous studies have shown the benefit of synthetic delta-t-tetrahydrocannabinol (THC) and medical cannabis for a range of sleep disorders, however these trials were mainly targeted to investigate outcomes in other conditions such as pain and multiple sclerosis. The aim of this study is to provide preliminary evidence for orally delivered medical cannabis for the treatment of sleep disorders due to insomnia. This trial will enrol 24 participants aged (25-70) inclusive who have insomnia defined as self-reported difficulty initiating and/or maintaining sleep for 3 or more nights per week for at least 3 months. Participants will also be screened with a clinically validated questionnaire for insomnia by an Investigator team member before being recruited into the trial. Participants involvement in the trial will be for approximately 8-11 weeks (depending on their availability to take the assessments). After completing a series of health asessments and questionnaires relating to their sleep, participants will commence the trial with a 2 week period of baseline measures (without investigational product or placebo) where they will need to wear a wrist-worn device to measure their quantity and quality of their sleep, as well as complete a sleep diary. On the final night of the 2 week period (night 14) they will have an overnight sleep study at the sleep centre site using a non-invasive measuring device to measure sleep patterns and assessments with questionnaires about their sleep by the Investigator team. Following a 1 week break, participants will be randomly allocated (by chance) to receive investigational product or placebo. Each of the treatment phases of both investigational product and placebo will be for 2 week periods including a 1 week break in between the treatments. The same requirements including measurements and assessments as per the baseline will be requried for each of the 2 week periods of investigational product and placebo. This trial will provide information on the efficacy of medical cannabis for the treatment of sleep disorders due to insomnia.

Eligibility

Sex: Both males and femalesMin Age: 25 YearssMax Age: 70 Yearss

Inclusion Criteria5

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 Criteria20

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.

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Interventions

This trial is a randomised double-blind placebo controlled cross-over study evaluating the efficacy of an oral medicinal cannabis extract (ZTL-101) containing cannabinoids for improving sleep in people with insomnia. Each investigational product dose (0.5 mL of ZTL-101) is self-administered sublingually once daily at night one hour before bedtime for 14 days. Adherence to the intervention treatment is monitored using the sleep diary where daily doses are recorded and return of any unused investigational product to the study site at the end of the 14 day treatment period. Wash-out period between treatments is 1 week.