Cannabis for Opioid Substitution Trial

Opioid Use Clinical Trial

— COST  

Official title:

Cannabis for Opioid Substitution Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03859089
• Other study ID #: 17-96275KCRA
• Status: Recruiting
• Start date: October 10, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: February 2019
• Source: Cannabis Research Associates
• Contact: Andrea J Afinec, BScH
• Phone: 647 341-4230
• Email: aafinec[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to define common strains of cannabis that adult chronic cancer and non-cancer pain syndrome patients are using as a replacement for opioids (narcotics). Identified strains, if any, will then be tested via randomized controlled trials to support an application for a Health Canada Drug Identification Number.

Description:

The search for safer alternatives to opioids for treating chronic cancer and non-cancer pain syndromes currently is an important initiative. Cannabis Research Associates (CRA) has been commissioned by Northern Green Canada Inc. to conduct a multi-phase study that will first define common strains of cannabis that patients use as a replacement for opioids, then conduct a randomized controlled trial to support an application to Health Canada for a Drug Identification Number. This protocol summarizes the methods for phase I.

In total, the Investigators plan to recruit 1,200 adult patients (> 25 years) currently using cannabis to treat chronic cancer and non-cancer pain syndromes conditions. Patients will be recruited from six pain clinics throughout Ontario. Pain clinics have not yet been identified. The study Investigators will invite licensed physicians from various private pain clinics to collaborate on this study.

This is an observational cohort study involving a mixed methods approach. Patients interested in participating will have the option to have an online survey link emailed to them so they can complete the survey at a convenient time. Or, patients can choose to complete the online survey in person with the assistance of a Research Assistant. Research Assistants will have hard copy surveys to serve as a back-up solution should they be faced with Internet connectivity and/or online survey hosting issues. No personal identifying information will be collected. Hard copy data will be stored in locked cabinets and shipped via courier to Cannabis Research Associates in batches.

All aspects of this study will be executed under the supervision of the study Investigators. Scientific independence from the sponsoring body will be maintained, and no censorship of data management, analysis, or presentation/publication will be permitted.

This study will be executed under the approval and ongoing supervision of the Research Ethics Board, as required.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: October 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients aged > 25 years—CPSO Policy states that physicians cannot prescribe medical cannabis to persons under the age of 25 unless all other conventional therapies have failed. Furthermore, there is evidence to support that cannabis use in younger persons can have lasting effects since the brain is still developing (Wier K, 2015).

2. English-speaking, or with the assistance of a family member/friend that can interpret English for the patient.

3. Qualifying medical diagnosis for appropriate use of medical cannabis by a licensed physician.

4. Current medical cannabis use to treat chronic cancer and non-cancer pain syndromes.

5. Current or past use of prescription opioids to treat chronic cancer and non-cancer pain syndromes.

Exclusion Criteria:

1. Patients taking medical cannabis for reasons other than chronic cancer and non-cancer pain syndromes

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse
• Opioid Use
• Pain Syndrome

Intervention

Other:
• Medical Cannabis
N/A - Observational Cohort Study

Locations

Country	Name	City	State
Canada	Synergy Health Services Inc.	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Cannabis Research Associates

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannabis as replacement for opioids	Define common strains of cannabis that patients are using as a replacement for opioids (should any exist)	Through study completion, an average of 1 year