Improving Pain Disability With the Use of Oral Cannabinoids

NCT05351905 | Completed

• 1 other identifier: 19-5944
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Opioid Use; Cannabis

Outcome Measures

Primary Outcomes (5)

• Feasibility outcome: pertaining to the patients recruitment

  The ability to recruit the necessary number of patients during the estimated 12-month period

  Through study completion, an average of 1 year

• Feasibility outcome: pertaining to adherence to intervention

  Defined as ≥70% of patients taking ≥70% of the prescribed doses and assessed from the participant-kept study drug diary data at each study visit.

  Up to 12 weeks post-treatment

• Feasibility outcome: pertaining to withdrawal from study

  Participant withdrawal from the study \<20%

  Up to 12 weeks post-treatment

• Feasibility outcome: pertaining to questionnaire data

  The amount of missing data from all questionnaires \<20%

  Up to 12 weeks post-treatment

• Feasibility outcome: the rate of unintentional unblinding

  Defined as the participant correctly identifying group allocation and blinding success will be quantified using the BANG Index.

  Up to 12 weeks post-treatment

Secondary Outcomes (2)

• The mean Morphine Equivalent (MEQ) dose (mg/day) at 12 weeks post-treatment for patients that were consuming opioids at the start of the trial

  Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment

• The mean pain interference at 12 weeks post-treatment

  Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment

Other Outcomes (6)

• The proportion of patients weaned off opioids at 12 weeks post-treatment initiation for patients that were consuming opioids at the start of the trial

  12-weeks post-treatment

• Mean pain severity scores at 12-weeks post-treatment

  Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment

• Overall improvement related to the intervention

  Baseline and at 2-,4-,6-,8- and 12-weeks post-treatment

Study Arms (3)

CBD oil

EXPERIMENTAL

Participants will receive CBD (cannabidiol) oil for a total duration of 12 weeks.

Drug: CBD oil ( MPL-001)

CBD+THC oil

EXPERIMENTAL

Participants will receive CBD (cannabidiol) oil in combination with THC (delta-9-tetrahydrocannabinol) for a total duration of 12 weeks.

Drug: CDB+THC oil (MPL-005)

Placebo oil

PLACEBO COMPARATOR

Participants will receive matching placebo oil for a total duration of 12 weeks.

Drug: Placebo oil

Interventions

CBD oil ( MPL-001) DRUG

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.

Also known as: CBD concentrate

CBD oil

CDB+THC oil (MPL-005) DRUG

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.

Also known as: CBD concentrate

CBD+THC oil

Placebo oil DRUG

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.

Also known as: Matching placebo

Placebo oil

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 25 years
• Able to understand and read English
• Experiencing chronic, non-palliative pain

You may not qualify if:

• Use of nabilone, nabiximols or cannabis in the 30 days preceding study recruitment
• Known allergy to cannabis or any cannabinoid
• Serious ongoing medical issues (i.e., lung, liver, kidney or heart disease) that in the opinion of the Investigator would compromise the safety of the patient
• Current uncontrolled serious mental disorders such as schizophrenia, or psychosis
• Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of child bearing potential during pretreatment evaluation)
• Men and women planning to start a family in the next 12 weeks
• Has declared a current alcohol or substance use disorder (excluding opioid use disorder)
• Currently using Methadone or Buprenorphine
• Patients who are naïve to pain treatments

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Chronic Pain; Marijuana Abuse

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Hance Clarke, MD, PhD

  Toronto General Hospital, UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients, study staff, care providers, adjudicators, data analysts and investigators will be blinded to the active ingredient(s) in the study medication and group allocation. Blinding of all research team members who interact with the patient will avoid biases in communications with, or treatment of, participants based on group allocation. Blinding of research participants will avoid any bias in reporting (e.g., of pain ratings, side effects) and actions/behaviours during the study (e.g., opioid medication dose adjustments) based on group allocation and/or expectations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Model Details: Participants will be randomized to receive either a placebo, CBD oil (medical cannabis) or CBD+THC oil (medical cannabis) in a 1:1:1 ratio.

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 28, 2022
• Study Start: November 22, 2022
• Primary Completion: December 31, 2025
• Study Completion: January 12, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)