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.
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.
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DOI：
10.1136/bmjopen-2022-064457
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发表时间：
2022-06-09
期刊：
影响因子：
2.9
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中科院分区：
文献类型：
--
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慢性非癌症疼痛影响美国约5000万成年人（20%），其中约25%的人接受慢性处方阿片类药物治疗疼痛，尽管经验疗效数据有限，阿片类药物使用障碍和阿片类药物过量的剂量相关风险很大。此外，尽管缺乏疗效数据，但有许多报告称，人们使用大麻产品来控制慢性疼痛并替代或减少慢性阿片类药物。在这里，我们描述了一项随机试验的协议，大麻的影响，当添加到行为疼痛管理和处方阿片类药物减量支持计划，阿片类药物的使用，疼痛强度和疼痛干扰。这是一项实用的，单盲，随机，等待列表对照试验，旨在招募250名成年人，他们以每天≥25毫克吗啡当量的稳定剂量服用处方阿片类药物治疗慢性非癌症疼痛，并表示有兴趣使用大麻来减轻疼痛，阿片类药物剂量或两者兼而有之。所有参与者将接受每周一次的24次处方阿片类药物锥形支持组行为疼痛管理干预。参与者将以1：1的比例被随机分配使用大麻产品，主要来自商业大麻药房，或放弃使用大麻6个月。共同主要结局是处方监测项目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。次要结果包括生活质量，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。所有其他结局均为探索性结局。我们将记录不良事件。本研究已获得马萨诸塞州General Brigham机构审查委员会的伦理批准（#2021P000871）。研究结果将发表在同行评审的期刊上，并在国家会议上发表。NCT 04827992。
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. 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. 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. NCT04827992.
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