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Improving Pain Disability With the Use of Oral Cannabinoids
Sponsor: University Health Network, Toronto
Summary
The investigators are conducting a pilot (i.e. a small study) in order to find out the effectiveness and safety of medical cannabis in the management of chronic pain. At the end of this 3 month study, investigators will gather information on how easy it is for patients to enroll and complete the entire study. The results of this pilot study will help the study team design a larger randomized controlled trial.
Official title: A Single-centre, Pilot, Randomized Controlled Trial of Oral Cannabinoids for Improving Pain Disability in Patients With Chronic Pain
Key Details
Gender
All
Age Range
25 Years - Any
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2022-11-22
Completion Date
2026-01-12
Last Updated
2026-07-22
Healthy Volunteers
No
Conditions
Interventions
CBD oil ( MPL-001)
MPL-001: which is a 25:1 Cannabidiol (CBD): ∆9-tetrahydrocannabidiol (THC) oral formulation with a concentration of 50 mg/ml of CBD and 2 mg/ml of THC. The starting dose will be 1 mL per day (50 mg CBD) orally and gradually titrated to a maximum dose of 6 mL (300 mg CBD) per day in a divided dosage within 6 to 8 weeks of treatment initiation based on patient assessment. Once the optimal dose has been determined, which maximizes potential therapeutic effects while minimizing adverse effects, the dose will be maintained for the remainder of the trial.
CDB+THC oil (MPL-005)
MPL-005: which is a 5:1 Cannabidiol (CBD):∆9-tetrahydrocannabidiol (THC) oral formulation with a concentration of 25 mg/ml of CBD and 5 mg/ml of THC. The starting dose will be 1 mL per day (25 mg CBD + 5 mg THC) orally and gradually titrated to a maximum dose of 6 mL (150 mg CBD + 30 mg THC) per day in a divided dosage within 6 to 8 weeks of treatment initiation based on patient assessment. Once the optimal dose has been determined, which maximizes potential therapeutic effects while minimizing adverse effects, the dose will be maintained for the remainder of the trial.
Placebo oil
The starting dose will be 1 mL per day (contains no API) orally and gradually titrated to a maximum dose of 6 mL per day in a divided dosage within 6 to 8 weeks of treatment initiation based on patient assessment. Once the optimal dose has been determined, which maximizes potential therapeutic effects while minimizing adverse effects, the dose will be maintained for the remainder of the trial.
Locations (1)
University Health Network
Toronto, Ontario, Canada