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

项目摘要/摘要 医用大麻(MM)对成人慢性非癌症患者的风险收益比存在争议 慢性阿片类药物治疗(COT)的疼痛(CNCP)。在美国，大约有5000万成年人患有 CNCP，一种令人衰弱的医疗状况，管理起来很复杂。大多数患有CNCP的人是 接受COT治疗，但有证据支持阿片类药物治疗疼痛的长期有效性和改善 功能状态较弱，大剂量的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 服药过量死亡。由于这一患者群体复杂的医疗需求，人们对 MM治疗CNCP的潜力然而，支持MM治疗的有效性的证据 慢性疼痛或减少阿片类药物的使用很弱，而且存在与MM有关的风险。因此， 使用阿片类药物的CNCP患者是否应该使用MM作为COT的辅助治疗仍存在争议。 而且还没有直接解决这个问题的随机研究。我们建议招收 250名患有神经病理性疼痛的成年人接受了6个月的CNCP，他们接受了50-300剂量的COT 90天内未使用但正在考虑使用MM并且报告有兴趣缩减的人员/天 他们的COT剂量，纳入随机、务实的3个现场试验。参与者将被随机分配开始MM 在注册时或到等待名单控制条件(WL)，并在24周内不启动MM。所有参与者都将是 提供了为期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 COT上CNCP患者是否被分配到MM POTS组，与那些被分配到 WL POTS，显示(1)更大的COT剂量减少(MME/天)，和/或疼痛严重程度的更大改善 疼痛数字评定量表(共同主要结果)，(2)改善生活质量，(3)改善疼痛干预， 抑郁和焦虑；以及(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。我们亦会在年内评估委员会的发展。 那些使用MM的人在每次探视时收集的尿液将被定量评估大麻代谢物。这个 拟议的研究将回答一个及时而重要的公共卫生问题，即MM是否与 与单纯的行为支持相比，行为支持对这一群体是有益的，也是有害的。这 信息对于患者、医疗保健提供者和政策制定者评估以下各项的风险和好处至关重要 MM作为COT治疗CNCP的辅助治疗。

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.