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Canadian Registry for the Use of Spectrum Therapeutics Cannabis Products in Subjects With Chronic Pain

NCT04763252 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-08-15

No results posted yet for this study

Summary

Chronic pain affects at least 10% of the global population but is often poorly managed, given the variable efficacy of available pharmacological treatments and the limited accessibility of multidisciplinary interventions. The legalization of cannabis in at least 14 countries and the increasing regulatory approval of cannabis preparations and synthetic cannabinoids and analogues have led to a growing interest in the use of medical cannabis products to manage chronic pain. This use is supported by research demonstrating important interactions between cannabinoids and the human endocannabinoid system and pain modulation pathways. While medical cannabis products are increasingly available to practitioners who treat pain, there is little evidence-based guidance for prescribing or titrating these treatments to manage chronic non-cancer pain. This prospective registry aims to assemble real-world data regarding the use of Spectrum Therapeutics (ST) medical cannabis products in subjects with chronic non-cancer pain in Canada. The registry will also assess treatment outcomes, including pain and related symptoms, global impressions of improvement, and change in concomitant pain medications (opioid use in particular), to better inform the utility of ST products for chronic non-cancer pain management.

Primary Objective:

• To describe patterns of physician selection of Spectrum Therapeutics (ST) medical cannabis treatment regimen, expressed as average daily dose of THC and CBD (in mg), and mode of administration (ingested or inhaled), in the management of chronic non-cancer pain in countries where these products are commercially available.

Secondary Objectives:

* To describe subject product and dose adjustment (under medical follow-up) over time.
* To assess outcomes of treatment, including pain relief and effects on sleep, daily functioning, and quality of life.
* To assess global impressions of treatment effectiveness as reported by subjects and physicians.
* To assess changes in daily dose of opioids, other medications over time.

Safety Objective:

• To assess the safety and tolerability of ST products in subjects with chronic pain.

Conditions

Interventions

OTHER

Spectrum Therapeutics cannabis products

For the purposes of this study, subjects enrolled will have been authorized Spectrum Therapeutics (ST) products that are commercially available in Canada. The full repertoire of Spectrum Therapeutics products are outlined on the website https://www.spectrumtherapeutics.com/canada/en/patients/products. It encompasses six "colors" (order from Red to Yellow follows the descending THC:CBD ratio), and five types of formulations: soft gels, spray, oil, flowers and vapes). Refer to webpage for the most up to date products available per country https://www.spectrumtherapeutics.com/canada/en/patients/products.

Sponsors & Collaborators

  • Canopy Growth Corporation

    lead INDUSTRY

Principal Investigators

  • Dwight Moulin, MD · Earl Russell Chair Pain Medicine, Western University

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2023-07-30
Completion
2023-07-30

Countries

  • Canada

Study Locations

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Entities

Diseases

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 NCT04763252 on ClinicalTrials.gov