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COMPLETED
NCT05351905
NA

Improving Pain Disability With the Use of Oral Cannabinoids

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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