随机、务实、候补对照试验：在减少慢性非癌痛成人阿片类药物用量和疼痛方面，添加大麻辅助处方阿片类药物支持的效果：研究方案。

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.

机构信息

Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.

Department of Medicine, Cambridge Health Alliance, Somerville, Massachusetts, USA.

出版信息

BMJ Open. 2022 Jun 9;12(6):e064457. doi: 10.1136/bmjopen-2022-064457.

DOI:10.1136/bmjopen-2022-064457

PMID:35680252

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9185656/

Abstract

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.

摘要

简介

慢性非癌性疼痛影响了美国约 5000 万成年人（占 20%），其中约 25%的人因疼痛而长期接受慢性处方阿片类药物治疗，尽管其疗效数据有限，且存在与剂量相关的阿片类药物使用障碍和阿片类药物过量的风险。尽管缺乏疗效数据，但有许多关于人们使用大麻制品来管理慢性疼痛并替代或减少慢性阿片类药物的报告。在这里，我们描述了一项随机试验的方案，该试验旨在研究在行为性疼痛管理和处方阿片类药物减量支持计划中加入大麻对阿片类药物使用、疼痛强度和疼痛干扰的影响。

方法

这是一项实用的、单盲的、随机的、等待对照试验，旨在招募 250 名每天稳定服用 ≥25 吗啡毫克当量的处方阿片类药物治疗慢性非癌性疼痛的成年人，这些成年人对使用大麻来减轻疼痛、减少阿片类药物剂量或同时减少疼痛和阿片类药物剂量表示兴趣。所有参与者都将接受每周 24 节的处方阿片类药物减量支持小组行为性疼痛管理干预。参与者将以 1:1 的比例随机分配使用大麻产品，主要从商业大麻药房获得，或在 6 个月内不使用大麻。主要结局是经处方监测计划验证的阿片类药物剂量的变化和疼痛、享受、一般活动量表评分的变化。次要结局包括生活质量、抑郁、焦虑、自我报告的阿片类药物剂量以及阿片类药物和大麻使用障碍症状。所有其他结果将是探索性的。我们将记录不良事件。