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Cannabinoids for Insomnia (CANMDD Trial)

Phase 2
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
Diagnosis of Insomnia Disorder according to the Duke Structured Interview for Sleep Disorders 38 Patient Health Questionnaire (PHQ-9) 39 score of <10, indicating severity of mild-to-no depression (This criterion is important because a proper diagnosis of current co-morbid insomnia disorder cannot be accurately ascertained during acute major depressive episodes)
Participant must be willing and able to complete self-reported assessments, including having sufficient fluency in English
Screening 3 weeks
Treatment Varies
Follow Up 1 year, at the completion of the study
Awards & highlights

CANMDD Trial 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.Check my eligibility
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.See study design
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.

CANMDD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I have been diagnosed with insomnia and have mild or no depression.
I can complete surveys in English by myself.
I am willing to wear an activity tracking device on my wrist.
I've been on the same dose of antidepressants, except sleep aids, for at least 2 months.
I am 19 years old or older.

CANMDD Trial 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

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

CANMDD 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
196 Previous Clinical Trials
25,484 Total Patients Enrolled
McMaster UniversityOTHER
880 Previous Clinical Trials
2,597,768 Total Patients Enrolled
Nirushi Kuhathasan, PhDStudy ChairSt. Joseph's Healthcare Hamilton

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant intake for this experiment?

"Affirmative. According to the documentation on clinicaltrials.gov, this medical study was first advertised on August 28th 2023 and is currently seeking 60 patients from one site."

Answered by AI

What risks are associated with utilizing High CBD [25:1]?

"Considering the limited data available regarding High CBD [25:1], our team at Power deems its safety to be a 2 out of 3. This is due to it being in Phase 2, which entails some evidence on safety but no proof for efficacy."

Answered by AI

Is this experiment currently admitting participants?

"Affirmative. The information found on clinicaltrials.gov indicates that this experiment is still recruiting subjects; it was first posted to the website on August 28th 2023 and underwent its most recent update September 6th. The trial requires 60 patients from a single location in order to reach completion."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
What site did they apply to?
St. Joseph's Healthcare Hamilton

Why did patients apply to this trial?

I've been diagnosed with fibromygia which is very painful. Insomnia . Fatigue is bad.
PatientReceived 2+ prior treatments
Because I have been taking ambien for the last three years, 10mg, and it has not been working well. I have been trying to get a good nights rest since 2010-2011. I have tried various medications but nothing has seemed to help without major side effects, this is of course besides the ambien. I have seen many doctors in utah but I think it's time I look else where for help.
PatientReceived no prior treatments
~38 spots leftby Apr 2025