Cannabis for Opioid Substitution Trial (COST)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03859089 |
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Recruitment Status : Unknown
Verified February 2019 by Cannabis Research Associates.
Recruitment status was: Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
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| Condition or disease | Intervention/treatment |
|---|---|
| Pain Syndrome Opioid Use Cannabis Use | Other: Medical Cannabis |
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.
| 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 |
- Other: Medical Cannabis
N/A - Observational Cohort Study
- 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)
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.
| 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 |
Inclusion Criteria:
- 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).
- English-speaking, or with the assistance of a family member/friend that can interpret English for the patient.
- Qualifying medical diagnosis for appropriate use of medical cannabis by a licensed physician.
- Current medical cannabis use to treat chronic cancer and non-cancer pain syndromes.
- 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
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
| Contact: Andrea J Afinec, BScH | 647 341-4230 | aafinec@gmail.com |
| Canada, Ontario | |
| Synergy Health Services Inc. | Recruiting |
| Hamilton, Ontario, Canada | |
| Contact: Ira Price, MD FRCPC 1-855-800-2226 | |
| Principal Investigator: | Ira Price, MD | Cannabis Research Associates |
| Responsible Party: | Cannabis Research Associates |
| ClinicalTrials.gov Identifier: | NCT03859089 |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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medical cannabis opioids pain substitution alternative |
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Marijuana Abuse Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |