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

NCT04763252 | Unknown

• 1 other identifier: #710-4502
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Physician selection of Spectrum Therapeutics (ST) medical cannabis treatment regimen and changes over time

  average daily dose of THC and CBD (in mg); by route of administration (inhaled or ingested).

  Collected at each physician-verified visit (5) over the course of 1-year.

Secondary Outcomes (7)

• Subject selection of ST treatment regimen and changes over time in

  Collected at each subject-verified visit (4) over the course of 1-year.

• To assess outcomes of treatment including pain relief and effects on sleep

  Collected at all follow-ups over the course of 1-year

• To assess outcomes of treatment including daily functioning, and quality of life

  Collected at all follow-ups over the course of 1-year

• To assess global impressions of treatment effectiveness as reported by physicians.

  Collected at all follow-ups over the course of 1-year.

• To assess global impressions of treatment effectiveness as reported by subjects

  Collected at all follow-ups over the course of 1-year.

Other Outcomes (1)

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

  Collected at all follow-ups over the course of 1-year

Study Arms (1)

Canadian

Other: Spectrum Therapeutics cannabis products

Interventions

Spectrum Therapeutics cannabis products OTHER

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.

Canadian

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic non-cancer pain patients who received a prescription for a Spectrum Therapeutics medical cannabis product.

You may qualify if:

• Subject ≥ 25 years of age with a diagnosis of chronic non-cancer pain defined as pain lasting or recurring over a period \> 3 months (IASP-ICD-11 classification, refer to Appendix 6).
• Subject is, in the physician's opinion, a candidate for medical cannabis treatment. Candidate status will be determined based on local regulations, common clinical practice, available guidelines and scientific literature, and the physician's expertise or experience with medical cannabis products.
• Subject received a prescription/authorization for a product in the medical channel of Spectrum Therapeutics.
• Subject is able to read and understand the informed consent form and complete the study questionnaires.

You may not qualify if:

• Subject refuses to provide informed consent or participate in any aspect of the study.
• Subject is pregnant or lactating.
• Subject has a history of psychosis or schizophrenia (or other significant psychiatric disorder), including among first-degree relatives.
• Subject has a suspected or confirmed cardiovascular disease.
• Subject is a liver transplant recipient or has severely compromised liver function.

Sponsors & Collaborators

• Canopy Growth Corporation: lead

Study Sites (1)

Burrard Pain Doctors

Vancouver, British Columbia, V6Z 2C7, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dwight Moulin, MD

  Earl Russell Chair Pain Medicine, Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 21, 2021
• Study Start: January 25, 2021
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: August 15, 2022

Record last verified: 2022-08

Locations

CA (1)