← Back to Search

Cannabinoid

Cannabinoids for Insomnia (CANMDD Trial)

Phase 2
Recruiting
Led By Benicio N Frey, MD, MSc, PhD
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be willing and able to complete self-reported assessments, including having sufficient fluency in English
Be older than 18 years old
Must not have
Presence of unstable medical conditions
Presence of any sleep disorder other than insomnia that is considered the primary diagnosis, determined by the Duke Structured Interview for Sleep Disorders (e.g. Sleep Apnea, Limb Movement Disorder, or Circadian Rhythm Disorders)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year, at the completion of the study

Summary

This trial will study the effects of cannabis oil on insomnia in people with MDD, and measure sleep, depression, cognitive functioning, etc.

Who is the study for?
Adults over 19 with insomnia and mild-to-no depression, diagnosed per specific criteria. Participants must speak English well enough for self-reports, wear an actiwatch, and can be on stable antidepressants (except sleep aids). Exclusions include certain psychiatric disorders, unstable medical conditions, pregnancy/breastfeeding without contraception, cannabis allergies, or recent substance abuse.
What is being tested?
This study tests the effectiveness of two different ratios of CBD/THC (25:1 and 5:1) against a placebo in treating insomnia among those with major depressive disorder. It's a pilot trial to see if a larger one would work. The trial will also measure sleep quality and other health outcomes like depression severity and cognitive function.
What are the potential side effects?
Potential side effects may include typical reactions to cannabinoids such as changes in mood or perception, dizziness, dry mouth, altered appetite or digestion issues. Specific side effects will be monitored including impact on cognitive functions and overall health-related quality of life.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can complete surveys in English by myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a medical condition that changes rapidly.
Select...
I have a sleep disorder other than insomnia, diagnosed by a specialist.
Select...
I am currently using sleep aids or benzodiazepines.
Select...
I am not allergic to cannabis or its components.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, at the completion of the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, at the completion of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recruitment Rate
Retention Rate
Secondary study objectives
Sleep latency onset and wake after sleep onset
Treatment compliance
Other study objectives
Cognitive Functioning
Health-Related Quality of Life (HRQoL)
Healthcare Resource Utilization and Work Productivity
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low CBD [5:1]Experimental Treatment1 Intervention
* 1 dose (1 mL) of LOW CBD * 10 mg/ml CBD and 2 mg/ ml THC
Group II: High CBD [25:1]Experimental Treatment1 Intervention
* 1 dose (1 mL) of HIGH CBD * 50 mg/ml CBD and 2 mg/ ml THC
Group III: PlaceboPlacebo Group1 Intervention
* 1 dose (1 mL) of PLACEBO * No active ingredients

Find a Location

Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor
201 Previous Clinical Trials
26,893 Total Patients Enrolled
10 Trials studying Depression
498 Patients Enrolled for Depression
McMaster UniversityOTHER
917 Previous Clinical Trials
2,616,294 Total Patients Enrolled
36 Trials studying Depression
5,813 Patients Enrolled for Depression
Nirushi Kuhathasan, PhDStudy ChairSt. Joseph's Healthcare Hamilton
~27 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top