Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocol
Introduction Chronic, non-cancer pain impacts approximately 50 million adults in the USA (20%), approximately 25% of whom receive chronic prescription opioids for pain despite limited empirical efficacy data and strong dose-related risk for opioid use disorder and opioid overdose. Also despite lack...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-06-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e064457.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832590068974354432 |
|---|---|
| author | A Eden Evins Ellie Grossman Julia Jashinski Aurora Quaye Corinne Cather Kevin Potter David A Schoenfeld Jodi M Gilman |
| author_facet | A Eden Evins Ellie Grossman Julia Jashinski Aurora Quaye Corinne Cather Kevin Potter David A Schoenfeld Jodi M Gilman |
| author_sort | A Eden Evins |
| collection | DOAJ |
| description | Introduction Chronic, non-cancer pain impacts approximately 50 million adults in the USA (20%), approximately 25% of whom receive chronic prescription opioids for pain despite limited empirical efficacy data and strong dose-related risk for opioid use disorder and opioid overdose. Also despite lack of efficacy data, there are many reports of people using cannabis products to manage chronic pain and replace or reduce chronic opioids. Here we describe the protocol for a randomised trial of the effect of cannabis, when added to a behavioural pain management and prescription opioid taper support programme, on opioid utilisation, pain intensity and pain interference.Methods This is a pragmatic, single-blind, randomised, wait-list controlled trial that aims to enrol 250 adults taking prescription opioids at stable doses of ≥25 morphine milligram equivalents per day for chronic non-cancer pain who express interest in using cannabis to reduce their pain, their opioid dose or both. All participants will be offered a weekly, 24-session Prescription Opioid Taper Support group behavioural pain management intervention. Participants will be randomly assigned in 1:1 ratio to use cannabis products, primarily from commercial cannabis dispensaries or to abstain from cannabis use for 6 months. Coprimary outcomes are change in prescription monitoring programme-verified opioid dose and change in Pain, Enjoyment, General Activity scale scores. Secondary outcomes include quality of life, depression, anxiety, self-reported opioid dose and opioid and cannabis use disorder symptoms. All other outcomes will be exploratory. We will record adverse events.Ethics and dissemination This study has ethical approval by the Massachusetts General Brigham Institutional Review Board (#2021P000871). Results will be published in peer-reviewed journals and presented at national conferences.Trial registration number NCT04827992. |
| format | Article |
| id | doaj-art-9dc0fc6ff41145b996bada7db57d2c61 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-9dc0fc6ff41145b996bada7db57d2c612025-01-24T02:50:09ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2022-064457Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocolA Eden Evins0Ellie Grossman1Julia Jashinski2Aurora Quaye3Corinne Cather4Kevin Potter5David A Schoenfeld6Jodi M Gilman7Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USADepartment of Medicine, Cambridge Health Alliance, Somerville, Massachusetts, USADepartment of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USADepartment of Anesthesiology, MaineHealth, Portland, Maine, USADepartment of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USADepartment of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA1Yale University, New Haven, CT, USADepartment of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USAIntroduction Chronic, non-cancer pain impacts approximately 50 million adults in the USA (20%), approximately 25% of whom receive chronic prescription opioids for pain despite limited empirical efficacy data and strong dose-related risk for opioid use disorder and opioid overdose. Also despite lack of efficacy data, there are many reports of people using cannabis products to manage chronic pain and replace or reduce chronic opioids. Here we describe the protocol for a randomised trial of the effect of cannabis, when added to a behavioural pain management and prescription opioid taper support programme, on opioid utilisation, pain intensity and pain interference.Methods This is a pragmatic, single-blind, randomised, wait-list controlled trial that aims to enrol 250 adults taking prescription opioids at stable doses of ≥25 morphine milligram equivalents per day for chronic non-cancer pain who express interest in using cannabis to reduce their pain, their opioid dose or both. All participants will be offered a weekly, 24-session Prescription Opioid Taper Support group behavioural pain management intervention. Participants will be randomly assigned in 1:1 ratio to use cannabis products, primarily from commercial cannabis dispensaries or to abstain from cannabis use for 6 months. Coprimary outcomes are change in prescription monitoring programme-verified opioid dose and change in Pain, Enjoyment, General Activity scale scores. Secondary outcomes include quality of life, depression, anxiety, self-reported opioid dose and opioid and cannabis use disorder symptoms. All other outcomes will be exploratory. We will record adverse events.Ethics and dissemination This study has ethical approval by the Massachusetts General Brigham Institutional Review Board (#2021P000871). Results will be published in peer-reviewed journals and presented at national conferences.Trial registration number NCT04827992.https://bmjopen.bmj.com/content/12/6/e064457.full |
| spellingShingle | A Eden Evins Ellie Grossman Julia Jashinski Aurora Quaye Corinne Cather Kevin Potter David A Schoenfeld Jodi M Gilman Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocol BMJ Open |
| title | Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocol |
| title_full | Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocol |
| title_fullStr | Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocol |
| title_full_unstemmed | Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocol |
| title_short | Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocol |
| title_sort | randomised pragmatic waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non cancer pain study protocol |
| url | https://bmjopen.bmj.com/content/12/6/e064457.full |
| work_keys_str_mv | AT aedenevins randomisedpragmaticwaitlistcontrolledtrialofcannabisaddedtoprescriptionopioidsupportonopioiddosereductionandpaininadultswithchronicnoncancerpainstudyprotocol AT elliegrossman randomisedpragmaticwaitlistcontrolledtrialofcannabisaddedtoprescriptionopioidsupportonopioiddosereductionandpaininadultswithchronicnoncancerpainstudyprotocol AT juliajashinski randomisedpragmaticwaitlistcontrolledtrialofcannabisaddedtoprescriptionopioidsupportonopioiddosereductionandpaininadultswithchronicnoncancerpainstudyprotocol AT auroraquaye randomisedpragmaticwaitlistcontrolledtrialofcannabisaddedtoprescriptionopioidsupportonopioiddosereductionandpaininadultswithchronicnoncancerpainstudyprotocol AT corinnecather randomisedpragmaticwaitlistcontrolledtrialofcannabisaddedtoprescriptionopioidsupportonopioiddosereductionandpaininadultswithchronicnoncancerpainstudyprotocol AT kevinpotter randomisedpragmaticwaitlistcontrolledtrialofcannabisaddedtoprescriptionopioidsupportonopioiddosereductionandpaininadultswithchronicnoncancerpainstudyprotocol AT davidaschoenfeld randomisedpragmaticwaitlistcontrolledtrialofcannabisaddedtoprescriptionopioidsupportonopioiddosereductionandpaininadultswithchronicnoncancerpainstudyprotocol AT jodimgilman randomisedpragmaticwaitlistcontrolledtrialofcannabisaddedtoprescriptionopioidsupportonopioiddosereductionandpaininadultswithchronicnoncancerpainstudyprotocol |