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

• 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
• 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

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.

项目总结/摘要 关于医用大麻（MM）对慢性非癌症成年人的风险效益比存在争议 慢性阿片类药物治疗（COT）。在美国，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。大多数患有CNCP的人是 用COT治疗，但证据支持阿片类药物对疼痛的长期有效性， 功能状态较弱，高剂量COT大大增加了阿片类药物使用障碍（OUD）和阿片类药物的风险 过量死亡由于这一患者群体的医疗需求复杂， MM治疗CNCP的潜力。然而，支持MM治疗CNCP的有效性的证据 慢性疼痛，或减少阿片类药物的使用，是薄弱的，并有风险与MM。因此， 使用阿片类药物的CNCP患者是否应该使用MM作为COT的辅助治疗仍然存在争议， 目前还没有直接针对这个问题的随机研究。我们建议注册 250名支持>6个月CNCP治疗神经性疼痛的成年人接受了剂量为50-300 MME/天>90天，未使用但正在考虑使用MM，并且报告有兴趣逐渐减少 他们的COT剂量，进入一个随机的，务实的3个地点的试验。受试者将被随机分配至开始MM 在登记时或等待列表控制条件（WL），并且在24周内不启动MM。所有参与者都有 提供为期24周的手动行为处方阿片类药物减量支持（POTS）计划。我们将评估 与分配至MM+POTS组的接受COT治疗的CNCP患者相比， WL+POTS，显示（1）COT剂量减少（MME/天）更大，和/或疼痛严重程度改善更大， 疼痛数字评定量表（共同主要结局），（2）改善生活质量，（3）改善疼痛干扰， 抑郁和焦虑;以及（4）认知功能（工作记忆、注意力和 执行功能表现），从基线至24周。我们亦会评估社区发展局在 将对每次访视时收集的尿液进行大麻代谢物的定量评估。的 拟议的研究将回答一个及时和重要的公共卫生问题，即MM是否与 与单独的行为支持相比，行为支持对这一人群是有益的还是有害的。这 信息对于患者、医疗保健提供者和政策制定者评估 MM作为CNCP COT的辅助治疗。