Evaluation of a Patient-Centred, Multidisciplinary Opioid Tapering Program for Individuals With Chronic Non-Cancer Pain on Long Term Opioid Therapy

NCT04902547 | Completed DMC

• 1 other identifier: HS23962
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Opioid Use; Opioids; Harmful Use; Hyperalgesia; Pain, Chronic

Keywords

ACT; Opioid; Chronic Pain; Opioid Tapering; Opioid Stewardship; Pain Management

Outcome Measures

Primary Outcomes (2)

• Opioid use

  Using morphine equivalent doses, changes in opioid use will be evaluated

  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

  Longitudinally, occurring at weekly/biweekly phone check-ins & in person visits at 0,3,6 and 12 months

Study Arms (2)

Multidisciplinary Tapering Program Only

EXPERIMENTAL

Patients in this arm will take part in the clinical multidisciplinary opioid tapering program (MTP).

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

Behavioral: Patient Education Workshop (PEWs); Procedure: Multidisciplinary Tapering Program

Interventions

Patient Education Workshop (PEWs) BEHAVIORAL

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.

Patient Education Workshop & Multidisciplinary Tapering Program

Multidisciplinary Tapering Program PROCEDURE

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.

Multidisciplinary Tapering Program Only; Patient Education Workshop & Multidisciplinary Tapering Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Winnipeg Regional Health Authority: collaborator

Study Sites (4)

ACCESS River East

Winnipeg, Manitoba, R3R 1K8, Canada

Location

ACCESS Winnipeg West

Winnipeg, Manitoba, Canada

Location

Health Sciences Centre Pain Clinic

Winnipeg, Manitoba, Canada

Location

Pan Am Pain Clinic

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

Hyperalgesia; Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Perceptual Disorders; Neurobehavioral Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients will be randomized to either Multidisciplinary Tapering Program Only or Patient Education Workshops PLUS Multidisciplinary Tapering Program

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 26, 2021
• Study Start: May 1, 2021
• Primary Completion: January 5, 2024
• Study Completion: April 5, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CA (4)