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 Article Swipe
Julia Jashinski
,
Ellie Grossman
,
Aurora Quaye
,
Corinne Cather
,
Kevin Potter
,
David Schoenfeld
,
A. Eden Evins
,
Jodi M. Gilman
·
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2022-064457
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2022-064457
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 .
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/bmjopen-2022-064457
- https://bmjopen.bmj.com/content/bmjopen/12/6/e064457.full.pdf
- OA Status
- gold
- Cited By
- 4
- References
- 62
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4282019803
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4282019803Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1136/bmjopen-2022-064457Digital Object Identifier
- 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 protocolWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2022Year of publication
- Publication date
-
2022-06-01Full publication date if available
- Authors
-
Julia Jashinski, Ellie Grossman, Aurora Quaye, Corinne Cather, Kevin Potter, David Schoenfeld, A. Eden Evins, Jodi M. GilmanList of authors in order
- Landing page
-
https://doi.org/10.1136/bmjopen-2022-064457Publisher landing page
- PDF URL
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https://bmjopen.bmj.com/content/bmjopen/12/6/e064457.full.pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
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https://bmjopen.bmj.com/content/bmjopen/12/6/e064457.full.pdfDirect OA link when available
- Concepts
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Medicine, Chronic pain, Cannabis, Opioid, Cancer pain, Medical prescription, Protocol (science), Randomized controlled trial, Clinical trial, Physical therapy, Alternative medicine, Psychiatry, Cancer, Internal medicine, Pharmacology, Receptor, PathologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
4Total citation count in OpenAlex
- Citations by year (recent)
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2025: 1, 2024: 2, 2023: 1Per-year citation counts (last 5 years)
- References (count)
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62Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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