MedTrace Logo

Cannabinoids as a Treatment for Insomnia in Major Depression

NCT05041647 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-01-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Placebo

* 1 dose (1 mL) of PLACEBO * No active ingredients

DRUG

25:1 CBD/THC

* 1 dose (1 mL) of HIGH CBD * 50 mg/ml CBD and 2 mg/ ml THC

DRUG

5:1 CBD/THC

* 1 dose (1 mL) of LOW CBD * 10 mg/ml CBD and 2 mg/ ml THC

Sponsors & Collaborators

Principal Investigators

  • Benicio N Frey, MD, MSc, PhD · St. Joseph's Healthcare Hamilton

  • Nirushi Kuhathasan, PhD · St. Joseph's Healthcare Hamilton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-28
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05041647 on ClinicalTrials.gov