Pain SyndromeCOSTNCT03859089
Cannabis for Opioid Substitution Trial
An observational study of Pain Syndrome and Opioid Use, run by Cannabis Research Associates at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Syndrome, Opioid Use, Cannabis Use
- What is being tested?
- Medical Cannabis
- How many people
- 1,200 participants
- Where
- 1 siteCanada
- Study dates
- 10 Oct 2017to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 1. Patients taking medical cannabis for reasons other than chronic cancer and non-cancer pain syndromes
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Synergy Health Services Inc.
Hamilton, Ontario
Ira Price, MD FRCPC, 1-855-800-2226
About this study
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.
Read the 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.
- Conditions
- Pain Syndrome, Opioid Use, Cannabis Use
- Being tested
- Medical Cannabis
- Keywords
- medical cannabis, opioids, pain, substitution, alternative
- Medical subject headings
- Somatoform Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical CannabisOther
N/A - Observational Cohort Study
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis as replacement for opioids
Define common strains of cannabis that patients are using as a replacement for opioids (should any exist)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start10 Oct 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cannabis Research Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ira Price, MD, Principal investigator, Cannabis Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859089
- Sponsor's protocol ID
- 17-96275KCRA
- Acronym
- COST
- Status last verified
- Feb 2019
- First submitted
- 22 Jul 2017
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A - no plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis for Opioid Substitution Trial
- ClinicalTrials.gov ID
- NCT03859089
- Acronym / sponsor ID
- COST / 17-96275KCRA
- Conditions
- Pain Syndrome, Opioid Use, Cannabis Use
- Keywords
- medical cannabis, opioids, pain, substitution, alternative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Cannabis Research AssociatesUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Patients taking medical cannabis for reasons other than chronic cancer and non-cancer pain syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical CannabisN/A - Observational Cohort Study | Other | – |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: No. N/A - no plans to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira Price, MD principal investigator
Cannabis Research Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Syndrome and Opioid Use, run by Cannabis Research Associates at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea J Afinec, BScH (647 341-4230, aafinec@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis as replacement for opioids (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.