Opioid UseNCT04902547
Evaluation of a Patient-Centred, Multidisciplinary Opioid Tapering Program for Individuals With Chronic Non-Cancer Pain on Long Term Opioid Therapy
A study testing Patient Education Workshop (PEWs) and Multidisciplinary Tapering Program in people with Opioid Use and Opioids; Harmful Use, run by University of Manitoba at 4 sites in Canada.
Trial summary
Chronic pain management is complex, with healthcare providers historically relying on prescribing opioid medications such as morphine. Although opioids may partially improve pain, there are risks associated with them as well, including pain worsening, side effects, addiction and overdose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Opioids; Harmful Use, Hyperalgesia
- What is being tested?
- Patient Education Workshop (PEWs) and Multidisciplinary Tapering Program
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesCanada
- Study dates
- 1 May 2021to 5 Apr 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CNCP on more than half the days in the previous 6 months
- use of opioids for more than half the days in the previous 90 days
- daily morphine equivalent dose equal to or greater than 50 mg
- age 18 years or older
- cognitive ability to understand questionnaires and participate in English only education sessions
- minimum average numerical pain rating of 3/10
Who cannot join
- Currently receiving ACT or CBT
- previous experience with ACT within the past 12 months
- significant uncontrolled depression with or without suicidal ideation
- current psychosis
- known or suspected opioid misuse/abuse based on a score of seven or greater on the Opioid Risk Tool
- known or suspected opioid diversion based on previous clinician report and/or results of urine drug screen
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
ACCESS River East
Winnipeg, Manitoba, R3R 1K8
ACCESS Winnipeg West
Winnipeg, Manitoba
Health Sciences Centre Pain Clinic
Winnipeg, Manitoba
Pan Am Pain Clinic
Winnipeg, Manitoba
About this study
Chronic pain management is complex, with healthcare providers historically relying on prescribing opioid medications such as morphine. Although opioids may partially improve pain, there are risks associated with them as well, including pain worsening, side effects, addiction and overdose. It is now understood that the management of chronic pain is more effective when multiple healthcare team members work together and incorporate multiple strategies instead of focusing solely on medications. An example of an effective, non-drug strategy for pain is a service offered by clinical psychologists called "Acceptance and Commitment Therapy" - or ACT - which empowers individuals, to implement alternative ways of thinking about and reacting to pain and its effect on their lives.
Canada has responded to the opioid overdose crisis with new guidelines that encourage physicians and those suffering from chronic pain to aim for lower opioid doses whenever possible, a process often referred to as "tapering." Unsurprisingly, tapering opioids is often difficult for patients to consider, primarily due to misconceptions that it will cause more harm than good.
This project aims to address these misconceptions by developing and offering an all-day educational workshop for patients, co-presented by a healthcare team (clinical psychologists, pharmacists and physicians), to provide in-depth information on opioid related risks and misconceptions, as well as a large component focusing on ACT training. Investigators then want to see if these sessions change individual attitudes towards opioid tapering and if it improves willingness and ability to successfully reduce opioid doses to a safer level.
Read the detailed description
Study Objectives:
- To evaluate the impact of a patient-centered, multidisciplinary opioid tapering program on overall opioid consumption in individuals with chronic pain on long-term opioid therapy.
- To implement opioid patient education workshops to be used in conjunction with the opioid tapering program and evaluate their preliminary feasibility and overall patient acceptance.
As Canada continues to witness a growing opioid crisis, the role of non-opioid medications and non-pharmacological strategies for pain, including behavioral treatments, is becoming more apparent. There is a great need to develop multidisciplinary clinical programs to assist individuals on long term opioid therapy to safely and effectively taper to safer doses of these potentially harmful medications. The use of nonpharmacological modalities will be integral to this process.
All patients enrolled in this project will be given the opportunity to take part in an informed and targeted multidisciplinary opioid tapering program (MTP). As well, half of the study population will be randomly assigned to also take part in a comprehensive opioid education and chronic pain workshop (Patient Education Workshop; PEW).
Abbreviated Methodology:
Individuals on LTOT at recruitment sites will be informed about the project by a member of their care team and those who show interest will be contacted and screened based on inclusion/exclusion criteria. Those who meet these criteria and consent to participate will be randomized to either the PEW + MTP cohort or the MTP only cohort. Depending on randomization, patients will then be invited to first attend a PEW or to attend a care visit to begin their tapering program. Participants completing the workshop will then begin the same tapering program at the MTP only cohort.
Multidisciplinary Tapering Program: Participants who have completed the Informed Consent Form ("MTP + PEW" and "MTP only" cohorts) will be included in the MTP, which will be conducted in collaboration with the patient's referring physician. All referring physicians from recruitment sites will be made aware of their role requirements in this study should their patients continue on to the MTP phase. Tapering programs will be individualized for all patients based on their current dose of opioid and clinical picture, and tapering planning will be co-managed by Drs. Amadeo and Turcotte, with the implementation and monitoring assistance of Pain Clinic nurses and Karin Ens (Clinical Pharmacist - ACCESS Winnipeg West). All participants will be asked to complete a battery of self-report measures of pain disability, pain, depression, anxiety, quality of life, pain acceptance, and valued living prior to the initiation of their tapering program (Baseline Visit) and again at 3-, 6-, and 12-month follow-up periods. Follow up has been identified as a crucial component of the MTP and will be managed by the clinical study team and clearly outlined in the detailed taper plan provided to referring physicians. Tapering plans and approaches may be changed (slowed, increased, halted etc.) based on results of this follow up at the discretion of study clinicians. Any changes/updates discussed with participants will be communicated to the referring physician with updated prescription or schedule changes. Like the tapering plan, the follow-up will be flexible and will depend on the patient's response to reductions and subsequent rate of taper. Follow up will include a combination of in-person and phone visits.
Patient Education Workshops: PEWs will be held as a full day session (approximately 9:30am to 3:30pm) and offerings will alternate between weekday and Saturday options to ensure flexibility for participants. Sessions will be offered monthly, or more often if the demand exists. The PEWs have been developed through a highly collaborative and interprofessional process and include some adaptations of previous work (used with permission) in order to create a session that is multidisciplinary, patient-centred and applicable to various forms of CNCP. The comprehensive workshops will include a combination of didactic and interactive content on general pain and opioid education (1 hour workshop session to be co-presented by Drs Ryan Amadeo and Dana Turcotte, and Karin Ens) along with significant psychological content (co-presented by Drs Brigitte Sabourin and Gregg Tkachuk) making up the remainder of the day-long workshop. Content presented in PEWs will include opioid-related risks, identifying motivation for (or barriers to) tapering, goal setting, pain self-management, sleep hygiene and comprehensive focus on ACT and rethinking pain. During the interprofessionally co-facilitated sessions, participants will be provided with workbooks that will contain session specific content as well as take-home activities and information for their own use.
Study Significance: The project will develop educational material aimed at furthering the understanding of both appropriate and inappropriate opioid prescribing in CNCP. This material will be available for consumption, beyond the project, with the knowledge users described. This will be undertaken at academic conferences, as well as at administrative gatherings in both academic and clinical settings. The knowledge created from this project, both in the program undertaken as well as in the collection and analysis of the endpoints outline, will allow for improved dialogue at all levels of health care. Both in the care of individual patients and in the public health approach to LTOT and opioid weaning, there will be improved understanding and process that will be accessible in broader primary care environments.
- Conditions
- Opioid Use, Opioids; Harmful Use, Hyperalgesia, Pain, Chronic
- Being tested
- Patient Education Workshop (PEWs), Multidisciplinary Tapering Program
- Keywords
- ACT, Opioid, Chronic Pain, Opioid Tapering, Opioid Stewardship, Pain Management
- Medical subject headings
- Hyperalgesia, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Education Workshop (PEWs)Behavioural
The comprehensive workshops will include a combination of didactic and interactive content on general pain and opioid education (1 hour workshop session to be co-presented by Drs Ryan Amadeo and Dana Turcotte) along with significant psychological content (co-presented by Drs Brigitte Sabourin and Gregg Tkachuk) making up the remainder of the day-long workshop. Content presented in PEWs will include opioid-related risks, identifying personal motivation for (or barriers to) tapering, goal setting, pain self-management, sleep hygiene and comprehensive focus on ACT and rethinking pain. During the interprofessionally co-facilitated sessions, participants will be provided with workbooks that will contain session specific content as well as take-home activities and information for their own personal use.
Multidisciplinary Tapering ProgramProcedure or surgery
The MTP will begin with a Baseline Tapering Visit and will include the same baseline health and well-being questionnaires, a medication review, relevant pain history, relevant opioid use history, discussion re: patient-specific tapering and functional goals, taper start date, and determination if a different opioid formulation will be required for the taper. A detailed taper plan will be prepared and reviewed by the study clinician(s) and provided to the patient. In general, tapers will begin with a 10% reduction of dose every 2 weeks until ⅓ of the original dose is met, or until taper goal has been met. If further tapering is planned once the patient reaches ⅓ of their original dose, the taper will be reduced to half the volume and rate noted above in order to improve tapering success.
Tapering plans and approaches may be changed (slowed, increased, halted etc.) based on follow up.
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary Tapering Program Only | Experimental | Patients in this arm will take part in the clinical multidisciplinary opioid tapering program (MTP). Receives: Procedure: Multidisciplinary Tapering Program |
| Patient Education Workshop & Multidisciplinary Tapering Program | Experimental | As above, though patients in this group will also take part in an opioid education workshop Receives: Behavioral: Patient Education Workshop (PEWs); Procedure: Multidisciplinary Tapering Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use
Using morphine equivalent doses, changes in opioid use will be evaluated
Measured: Longitudinally, occurring at weekly/biweekly phone check-ins & in person visits at 0,3,6 and 12 months
Pain level
Using VAS tool, changes in pain will be evaluated
Measured: Longitudinally, occurring at weekly/biweekly phone check-ins & in person visits at 0,3,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 May 2021
- Primary completion5 Jan 2024
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either Multidisciplinary Tapering Program Only or Patient Education Workshops PLUS Multidisciplinary Tapering Program
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Winnipeg Regional Health Authority
- Responsible party
- Principal investigator, Dr. Dana Turcotte, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902547
- Sponsor's protocol ID
- HS23962
- Status last verified
- Apr 2026
- First submitted
- 19 May 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Patient-Centred, Multidisciplinary Opioid Tapering Program for Individuals With Chronic Non-Cancer Pain on Long Term Opioid Therapy
- ClinicalTrials.gov ID
- NCT04902547
- Acronym / sponsor ID
- HS23962
- Conditions
- Opioid Use, Opioids; Harmful Use, Hyperalgesia, Pain, Chronic
- Keywords
- ACT, Opioid, Chronic Pain, Opioid Tapering, Opioid Stewardship, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Winnipeg Regional Health Authority
- Study start
- 1 May 2021 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 26 May 2021 (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.
Chronic pain management is complex, with healthcare providers historically relying on prescribing opioid medications such as morphine. Although opioids may partially improve pain, there are risks associated with them as well, including pain worsening, side effects, addiction and overdose. It is now understood that the management of chronic pain is more effective when multiple healthcare team members work together and incorporate multiple strategies instead of focusing solely on medications. An example of an effective, non-drug strategy for pain is a service offered by clinical psychologists called "Acceptance and Commitment Therapy" - or ACT - which empowers individuals, to implement alternative ways of thinking about and reacting to pain and its effect on their lives.
Canada has responded to the opioid overdose crisis with new guidelines that encourage physicians and those suffering from chronic pain to aim for lower opioid doses whenever possible, a process often referred to as "tapering." Unsurprisingly, tapering opioids is often difficult for patients to consider, primarily due to misconceptions that it will cause more harm than good.
This project aims to address these misconceptions by developing and offering an all-day educational workshop for patients, co-presented by a healthcare team (clinical psychologists, pharmacists and physicians), to provide in-depth information on opioid related risks and misconceptions, as well as a large component focusing on ACT training. Investigators then want to see if these sessions change individual attitudes towards opioid tapering and if it improves willingness and ability to successfully reduce opioid doses to a safer level.
Detailed description
Study Objectives:
- To evaluate the impact of a patient-centered, multidisciplinary opioid tapering program on overall opioid consumption in individuals with chronic pain on long-term opioid therapy.
- To implement opioid patient education workshops to be used in conjunction with the opioid tapering program and evaluate their preliminary feasibility and overall patient acceptance.
As Canada continues to witness a growing opioid crisis, the role of non-opioid medications and non-pharmacological strategies for pain, including behavioral treatments, is becoming more apparent. There is a great need to develop multidisciplinary clinical programs to assist individuals on long term opioid therapy to safely and effectively taper to safer doses of these potentially harmful medications. The use of nonpharmacological modalities will be integral to this process.
All patients enrolled in this project will be given the opportunity to take part in an informed and targeted multidisciplinary opioid tapering program (MTP). As well, half of the study population will be randomly assigned to also take part in a comprehensive opioid education and chronic pain workshop (Patient Education Workshop; PEW).
Abbreviated Methodology:
Individuals on LTOT at recruitment sites will be informed about the project by a member of their care team and those who show interest will be contacted and screened based on inclusion/exclusion criteria. Those who meet these criteria and consent to participate will be randomized to either the PEW + MTP cohort or the MTP only cohort. Depending on randomization, patients will then be invited to first attend a PEW or to attend a care visit to begin their tapering program. Participants completing the workshop will then begin the same tapering program at the MTP only cohort.
Multidisciplinary Tapering Program: Participants who have completed the Informed Consent Form ("MTP + PEW" and "MTP only" cohorts) will be included in the MTP, which will be conducted in collaboration with the patient's referring physician. All referring physicians from recruitment sites will be made aware of their role requirements in this study should their patients continue on to the MTP phase. Tapering programs will be individualized for all patients based on their current dose of opioid and clinical picture, and tapering planning will be co-managed by Drs. Amadeo and Turcotte, with the implementation and monitoring assistance of Pain Clinic nurses and Karin Ens (Clinical Pharmacist - ACCESS Winnipeg West). All participants will be asked to complete a battery of self-report measures of pain disability, pain, depression, anxiety, quality of life, pain acceptance, and valued living prior to the initiation of their tapering program (Baseline Visit) and again at 3-, 6-, and 12-month follow-up periods. Follow up has been identified as a crucial component of the MTP and will be managed by the clinical study team and clearly outlined in the detailed taper plan provided to referring physicians. Tapering plans and approaches may be changed (slowed, increased, halted etc.) based on results of this follow up at the discretion of study clinicians. Any changes/updates discussed with participants will be communicated to the referring physician with updated prescription or schedule changes. Like the tapering plan, the follow-up will be flexible and will depend on the patient's response to reductions and subsequent rate of taper. Follow up will include a combination of in-person and phone visits.
Patient Education Workshops: PEWs will be held as a full day session (approximately 9:30am to 3:30pm) and offerings will alternate between weekday and Saturday options to ensure flexibility for participants. Sessions will be offered monthly, or more often if the demand exists. The PEWs have been developed through a highly collaborative and interprofessional process and include some adaptations of previous work (used with permission) in order to create a session that is multidisciplinary, patient-centred and applicable to various forms of CNCP. The comprehensive workshops will include a combination of didactic and interactive content on general pain and opioid education (1 hour workshop session to be co-presented by Drs Ryan Amadeo and Dana Turcotte, and Karin Ens) along with significant psychological content (co-presented by Drs Brigitte Sabourin and Gregg Tkachuk) making up the remainder of the day-long workshop. Content presented in PEWs will include opioid-related risks, identifying motivation for (or barriers to) tapering, goal setting, pain self-management, sleep hygiene and comprehensive focus on ACT and rethinking pain. During the interprofessionally co-facilitated sessions, participants will be provided with workbooks that will contain session specific content as well as take-home activities and information for their own use.
Study Significance: The project will develop educational material aimed at furthering the understanding of both appropriate and inappropriate opioid prescribing in CNCP. This material will be available for consumption, beyond the project, with the knowledge users described. This will be undertaken at academic conferences, as well as at administrative gatherings in both academic and clinical settings. The knowledge created from this project, both in the program undertaken as well as in the collection and analysis of the endpoints outline, will allow for improved dialogue at all levels of health care. Both in the care of individual patients and in the public health approach to LTOT and opioid weaning, there will be improved understanding and process that will be accessible in broader primary care environments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to either Multidisciplinary Tapering Program Only or Patient Education Workshops PLUS Multidisciplinary Tapering Program
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary Tapering Program Only | Experimental | Procedure: Multidisciplinary Tapering ProgramPatients in this arm will take part in the clinical multidisciplinary opioid tapering program (MTP). |
| Patient Education Workshop & Multidisciplinary Tapering Program | Experimental | Behavioral: Patient Education Workshop (PEWs), Procedure: Multidisciplinary Tapering ProgramAs above, though patients in this group will also take part in an opioid education workshop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- CNCP on more than half the days in the previous 6 months
- use of opioids for more than half the days in the previous 90 days
- daily morphine equivalent dose equal to or greater than 50 mg
- age 18 years or older
- cognitive ability to understand questionnaires and participate in English only education sessions
Key exclusion criteria (6 listed)
- Currently receiving ACT or CBT
- previous experience with ACT within the past 12 months
- significant uncontrolled depression with or without suicidal ideation
- current psychosis
- known or suspected opioid misuse/abuse based on a score of seven or greater on the Opioid Risk Tool
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 |
|---|---|---|
| Patient Education Workshop (PEWs)The comprehensive workshops will include a combination of didactic and interactive content on general pain and opioid education (1 hour workshop session to be co-presented by Drs Ryan Amadeo and Dana Turcotte) along with significant psychological content (co-presented by Drs Brigitte Sabourin and Gregg Tkachuk) making up the remainder of the day-long workshop. Content presented in PEWs will include opioid-related risks, identifying personal motivation for (or barriers to) tapering, goal setting, pain self-management, sleep hygiene and comprehensive focus on ACT and rethinking pain. During the interprofessionally co-facilitated sessions, participants will be provided with workbooks that will contain session specific content as well as take-home activities and information for their own personal use. | Behavioural | Patient Education Workshop & Multidisciplinary Tapering Program |
| Multidisciplinary Tapering ProgramThe MTP will begin with a Baseline Tapering Visit and will include the same baseline health and well-being questionnaires, a medication review, relevant pain history, relevant opioid use history, discussion re: patient-specific tapering and functional goals, taper start date, and determination if a different opioid formulation will be required for the taper. A detailed taper plan will be prepared and reviewed by the study clinician(s) and provided to the patient. In general, tapers will begin with a 10% reduction of dose every 2 weeks until ⅓ of the original dose is met, or until taper goal has been met. If further tapering is planned once the patient reaches ⅓ of their original dose, the taper will be reduced to half the volume and rate noted above in order to improve tapering success. Tapering plans and approaches may be changed (slowed, increased, halted etc.) based on follow up. | Procedure or surgery | Multidisciplinary Tapering Program Only, Patient Education Workshop & Multidisciplinary Tapering Program |
Primary outcome
Opioid use
Time frame: Longitudinally, occurring at weekly/biweekly phone check-ins & in person visits at 0,3,6 and 12 months
Using morphine equivalent doses, changes in opioid use will be evaluated
Pain level
Time frame: Longitudinally, occurring at weekly/biweekly phone check-ins & in person visits at 0,3,6 and 12 months
Using VAS tool, changes in pain will be evaluated
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 6 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education Workshop (PEWs) and Multidisciplinary Tapering Program in people with Opioid Use and Opioids; Harmful Use, run by University of Manitoba at 4 sites 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 6 inclusion and 6 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 use (time frame: Longitudinally, occurring at weekly/biweekly phone check-ins & in person visits at 0,3,6 and 12 months). The study lists 2 primary outcomes in all. 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 6 May 2026.