Cannabinoids for Insomnia
(CANMDD Trial)

Recruiting in Palo Alto (17 mi)

Overseen byBenicio N Frey, MD, MSc, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: St. Joseph's Healthcare Hamilton

Prior Safety Data

Trial Summary

What is the purpose of this trial?This single-site study is a pilot, three-armed, double-blinded, placebo-controlled randomized controlled trial (RCT) that will determine the feasibility of a definitive RCT investigating the use of cannabis oil as a treatment for insomnia in individuals with MDD. The study will also determine whether standard THC with higher CBD vs lower CBD has a differential impact on insomnia. The study will also analyze other important objective parameters of sleep including total sleep time and sleep efficiency from actigraphy data. Optional polysomnography data may also be collected and analyzed. In addition, standardized, validated instruments will be used to collect data on severity of depressive symptoms, cognitive functioning biological rhythm disruption, daytime sleepiness, health-related quality of life (HRQoL), healthcare resource utilization, work productivity and activity impairment, as well as other side effects, in order to better understand the potential impact of the use of cannabis oil on these important health outcomes.

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with insomnia and have mild or no depression.

You have been diagnosed with Major Depressive Disorder using a specific interview called the SCID-5.

I can complete surveys in English by myself.

+5 more

Exclusion Criteria

I have a medical condition that changes rapidly.

I have a sleep disorder other than insomnia, diagnosed by a specialist.

People with certain mental health conditions like anxiety disorders, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or eating disorders will not be included. However, those with a history of major depressive disorder will be allowed to participate.

+5 more

Participant Groups

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.

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