Medical Marijuana, Pain, and Opioid Use in Patients with Chronic Non-cancer Pain

慢性非癌性疼痛患者的医用大麻、疼痛和阿片类药物的使用

基本信息

批准号：
10491683
负责人：
A EDEN EVINS
金额：
$ 81.74万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-30 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10491683
关键词：
Address Adjuvant Adjuvant Therapy Adult Anxiety Attention Behavior Therapy Behavioral Benefits and Risks Cannabis Chronic Complex Data Development Dose Effectiveness Enrollment Goals Health Personnel Intervention Legal Medical Medical Marijuana Memory Mental Depression Neuropathy Numeric Rating Scale Opioid Opioid Rotation Outcome Pain Pain interference Participant Patients Performance Pharmaceutical Preparations Population Provider Public Health Quality of life Randomized Reporting Risk Severities Short-Term Memory Site Support Groups Symptoms Testing Time United States Urine Visit Waiting Lists anxiety symptoms chronic pain chronic pain management cognitive function cognitive performance depressive symptoms diaries executive function functional status improved interest marijuana use mortality non-cancer chronic pain opioid mortality opioid overdose opioid tapering opioid therapy opioid use opioid use disorder pain patient painful neuropathy patient population pragmatic trial prescription opioid primary outcome programs secondary outcome symptomatic improvement trend virtual

项目摘要

PROJECT SUMMARY / ABSTRACT Controversy exists over the risk-to-benefit ratio of medical marijuana (MM) for adults with chronic non-cancer pain (CNCP) on chronic opioid therapy (COT). Approximately 50 million adults in the United States suffer from CNCP, a debilitating medical condition that is complex to manage. The majority of those with CNCP are treated with COT, but the evidence supporting long-term effectiveness of opioid drugs for pain and improved functional status is weak, and high-dose COT greatly increases risk for opioid use disorder (OUD) and opioid overdose death. Because of the complex medical needs of this patient group, there has been enthusiasm over the potential to treat CNCP with MM. However, evidence to support the effectiveness of MM to either treat chronic pain, or to reduce opioid use, is weak, and there are risks associated with MM. Thus, the issue of whether CNCP patients using opioids should use MM as an adjuvant therapy to COT remains controversial, and there have been no randomized studies that have directly addressed this question. We propose to enroll 250 adults who endorse >6 months of CNCP with neuropathic pain, have received COT at a dose of 50-300 MME/day for >90 days, who have not used but are considering use of MM, and who report interest in tapering their COT dose, into a randomized, pragmatic 3 site trial. Participants will be randomly assigned to begin MM at enrollment or to a waitlist control condition (WL), and not initiate MM for 24 weeks. All participants will be offered a 24-week, manualized behavioral prescription opioid taper support (POTS) program. We will evaluate whether patients with CNCP on COT who are assigned to MM+POTS, compared with those assigned to WL+POTS, show (1) greater COT dose reduction (MME/day), and/or greater improvement in pain severity on a pain numeric rating scale (co-primary outcomes), (2) improved quality of life, (3) improved pain interference, depression, and anxiety; and (4) improvement in cognitive functioning (working memory, attention, and executive function performance), from baseline to 24 weeks. We will also assess the development of CUD in those using MM. Urine collected at each visit will be assessed quantitatively for cannabis metabolites. The proposed study will answer a timely and significant public health question regarding whether MM use with behavioral support, compared to behavioral support alone, is beneficial or harmful for this population. This information is critical for patients, healthcare providers, and policymakers to evaluate the risks and benefits of MM as an adjuvant treatment to COT for CNCP.

项目概要/摘要对于成人慢性非癌症患者使用医用大麻（MM）的风险效益比存在争议慢性阿片类药物治疗 (COT) 引起的疼痛 (CNCP)。美国大约有 5000 万成年人患有 CNCP 是一种使人衰弱的疾病，管理起来很复杂。大多数 CNCP 患者是接受 COT 治疗，但证据支持阿片类药物对疼痛和改善的长期有效性功能状态较弱，高剂量COT大大增加阿片类药物使用障碍（OUD）和阿片类药物的风险服药过量死亡。由于该患者群体复杂的医疗需求，人们对用 MM 治疗 CNCP 的潜力。然而，有证据支持 MM 对任一治疗的有效性慢性疼痛或减少阿片类药物的使用效果较弱，并且存在与 MM 相关的风险。因此，问题使用阿片类药物的 CNCP 患者是否应该使用 MM 作为 COT 的辅助治疗仍存在争议，并且还没有直接解决这个问题的随机研究。我们建议报名 250 名同意接受超过 6 个月的神经性疼痛 CNCP 的成年人已接受剂量为 50-300 的 COT MME/天，持续 >90 天，尚未使用但正在考虑使用 MM，以及报告有兴趣逐渐减少的人他们的 COT 剂量，进入一项随机、务实的 3 点试验。参与者将被随机分配开始MM 在注册时或达到候补名单控制条件 (WL)，并且 24 周内不启动 MM。所有参与者都将提供为期 24 周的手动行为处方阿片类药物逐渐减少支持 (POTS) 计划。我们将评估与分配至 MM+POTS 的患者相比，接受 COT 治疗的 CNCP 患者是否被分配至 MM+POTS WL+POTS，显示 (1) COT 剂量减少更大（MME/天），和/或疼痛严重程度更大改善疼痛数字评定量表（共同主要结果），(2) 改善生活质量，(3) 改善疼痛干扰，抑郁和焦虑； (4) 认知功能的改善（工作记忆、注意力和执行功能表现），从基线到 24 周。我们还将评估 CUD 的发展使用MM的人。每次访视时收集的尿液将进行大麻代谢物的定量评估。这拟议的研究将回答一个及时且重要的公共卫生问题，即 MM 是否与与单独的行为支持相比，行为支持对该人群有利或有害。这信息对于患者、医疗保健提供者和政策制定者评估风险和收益至关重要 MM 作为 CNCP 的 COT 辅助治疗。