Cannabis Use, Opioid ConsumptionNCT04055662
A Comparison of Post-Operative Analgesia Requirements In Recreational Cannabis Users Versus Cannabis Naïve Inflammatory Bowel Disease Patients
An observational study of Cannabis Use, Opioid Consumption, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Cannabis is a drug that is widely used for recreational purpose. In most patients undergoing surgery, opioids are the most widely used mode of pain relief, during and following surgery. Anecdotally it has been observed that cannabis users required unexpectedly high doses of opioids. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cannabis Use, Opioid Consumption
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2019to 30 Mar 2020
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Elective IBD bowel surgery under general anesthesia
Who may be able to join
- Consent to participate and signed consent form.
- Age: 18-65 years.
- Elective IBD bowel surgery under general anesthesia.
- PCA use.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Post-Operative Analgesia Requirements In Recreational Cannabis Users
Cannabis is a drug that is widely used for recreational purpose. In most patients undergoing surgery, opioids are the most widely used mode of pain relief, during and following surgery. Anecdotally it has been observed that cannabis users required unexpectedly high doses of opioids. The purpose of this study is to compare opioid requirements between cannabis users and non- users after the surgery. Currently, post-operative opioid doses are determined based on various patient factors such as pre-operative opioid use, patient weight, age and sensitivity to opioids during surgery. Patients' requirements may be underestimated and opioid regimens need to be escalated in the first 24 hours in order to alleviate uncontrolled pain in cannabis users. Better understanding of the impacts of cannabis use on post-operative opioid requirements would help the Acute Pain Service optimize post-operative pain management for patients who use cannabis pre-operatively.
- Conditions
- Cannabis Use, Opioid Consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cannabis users | Not described | |
| Cannabis naive | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Amount of morphine equivalents on PCA
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Aug 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use, Opioid ConsumptionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055662
- Sponsor's protocol ID
- 2108.2.7
- Status last verified
- Aug 2019
- First submitted
- 12 Aug 2019
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Post-Operative Analgesia Requirements In Recreational Cannabis Users
- ClinicalTrials.gov ID
- NCT04055662
- Acronym / sponsor ID
- 2108.2.7
- Conditions
- Cannabis Use, Opioid Consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 14 Aug 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.
Cannabis is a drug that is widely used for recreational purpose. In most patients undergoing surgery, opioids are the most widely used mode of pain relief, during and following surgery. Anecdotally it has been observed that cannabis users required unexpectedly high doses of opioids. The purpose of this study is to compare opioid requirements between cannabis users and non- users after the surgery. Currently, post-operative opioid doses are determined based on various patient factors such as pre-operative opioid use, patient weight, age and sensitivity to opioids during surgery. Patients' requirements may be underestimated and opioid regimens need to be escalated in the first 24 hours in order to alleviate uncontrolled pain in cannabis users. Better understanding of the impacts of cannabis use on post-operative opioid requirements would help the Acute Pain Service optimize post-operative pain management for patients who use cannabis pre-operatively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis users | – | – |
| Cannabis naive | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Elective IBD bowel surgery under general anesthesia
Key inclusion criteria (4 listed)
- Consent to participate and signed consent form.
- Age: 18-65 years.
- Elective IBD bowel surgery under general anesthesia.
- PCA use.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Opioid consumption
Time frame: 2 years
Amount of morphine equivalents on PCA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cannabis Use, Opioid Consumption, run by Mount Sinai Hospital, Canada 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 4 inclusion and 0 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: finished, as of the sponsor's last update on 11 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 2 years). 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 11 Apr 2022.