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Cannabis for Opioid Substitution Trial (COST)

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ClinicalTrials.gov Identifier: NCT03859089
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Cannabis Research Associates

Brief 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.

Condition or disease Intervention/treatment
Pain Syndrome Opioid Use Cannabis Use Other: Medical Cannabis

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cannabis for Opioid Substitution Trial
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana


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


Primary Outcome Measures :
  1. Cannabis as replacement for opioids [ Time Frame: Through study completion, an average of 1 year ]
    Define common strains of cannabis that patients are using as a replacement for opioids (should any exist)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult chronic cancer and non-cancer pain syndrome patients currently taking medical cannabis and are currently or have previously taken opioids to treat pain.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859089


Contacts
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Contact: Andrea J Afinec, BScH 647 341-4230 aafinec@gmail.com

Locations
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Canada, Ontario
Synergy Health Services Inc. Recruiting
Hamilton, Ontario, Canada
Contact: Ira Price, MD FRCPC    1-855-800-2226      
Sponsors and Collaborators
Cannabis Research Associates
Investigators
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Principal Investigator: Ira Price, MD Cannabis Research Associates

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Responsible Party: Cannabis Research Associates
ClinicalTrials.gov Identifier: NCT03859089     History of Changes
Other Study ID Numbers: 17-96275KCRA
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: N/A - no plans to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cannabis Research Associates:
medical cannabis
opioids
pain
substitution
alternative
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents