Supplementary Material for: UK Medical Cannabis Registry: A Clinical Analysis of Patients with Substance Use Disorder

Background:
With a global rise in opioid-related mortality, comes a need to address this with novel therapies. Cannabinoid receptors are highly expressed and co-localised with opiate receptors of the mesolimbic system. Cannabis-based medicinal products (CBMPs) have been suggested as a measure to reduce harm as maintenance therapy for substance use disorder (SUD).

Aim:
To assess changes in patient-reported outcomes measures (PROMs) and opioid medications in individuals treated with CBMPs for SUD.

Methods:
Data from patients with SUD from the UK Medical Cannabis Registry was analysed. Outcomes included changes at 1, 3, and 6 months from baseline of the EQ-5D-DL, single-item sleep quality scale (SQS) and Generalised Anxiety Disorder-7 (GAD-7) questionnaire. Change in opioid medications was assessed as change in oral morphine equivalent (OME).

Results:
Thirty-four patients were included. Twenty-seven (79.41%) participants were male. Twenty-nine (85.29%) participants were illicit cannabis consumers at baseline. The most common SUD was opioid use disorder (n=18; 52.94%). Four (11.76%), 14 (41.18%), and 16 (47.05%), patients were prescribed oils, dried flower or a combination of dried flower and oils, respectively. Improvements in GAD-7, SQS, and EQ-5D-5L at 1, 3, and 6 months from baseline were observed (p<0.050). Median OME consumption at baseline was 274.95 [79.50-441.80] mg/day. This was reduced at 6 months (204.45 [61.88-354.85] mg/day; p=0.043), there was no significant difference at 1 or 3 months (p>0.050). Three (8.81%) participants reported 17 (50.00%) adverse events.

Conclusions:
There was an associated improvement in health-related quality of life PROMs and reduction in prescribed opioids in individuals with SUD treated with CBMPs. CBMPs were well tolerated by most individuals in this 6-month analysis. Further evaluation through randomised controlled trials is needed to determine causality.

背景：
随着阿片类相关死亡病例在全球范围内持续攀升，亟需探索新型治疗方案以应对这一公共卫生挑战。大麻素受体（Cannabinoid receptors）在中脑边缘系统中呈高表达状态，且与阿片受体高度共定位。有研究提出，大麻素类医药产品（Cannabis-based medicinal products, CBMPs）可作为物质使用障碍（substance use disorder, SUD）的维持治疗手段，以降低相关危害。

目的：
评估接受大麻素类医药产品（CBMPs）治疗的物质使用障碍（SUD）患者，其患者报告结局指标（patient-reported outcomes measures, PROMs）及阿片类药物使用的变化情况。

方法：
本研究分析了英国医用大麻登记库（UK Medical Cannabis Registry）中物质使用障碍患者的数据。观察结局包括基线后1、3及6个月时，EQ-5D-DL、单一项目睡眠质量量表（single-item sleep quality scale, SQS）及广泛性焦虑障碍7项量表（Generalised Anxiety Disorder-7, GAD-7）的评分变化；阿片类药物使用量的变化则以口服吗啡当量（oral morphine equivalent, OME）的变化进行评估。

结果：
本研究共纳入34例患者，其中27例（79.41%）为男性。基线时29例（85.29%）为非法大麻使用者。最常见的物质使用障碍为阿片类使用障碍（n=18；52.94%）。分别有4例（11.76%）、14例（41.18%）及16例（47.05%）患者被处方大麻素油、干燥大麻花或二者联合制剂。相较于基线，患者在随访1、3及6个月时的GAD-7、SQS及EQ-5D-5L评分均得到改善（p<0.050）。基线时口服吗啡当量的中位日均摄入量为274.95 [79.50-441.80] mg，至6个月时该摄入量有所降低（204.45 [61.88-354.85] mg/日；p=0.043），但在1及3个月时未观察到显著差异（p>0.050）。3例（8.81%）受试者共报告17起不良事件（占比50.00%）。

结论：
接受大麻素类医药产品（CBMPs）治疗的物质使用障碍患者，其健康相关生活质量相关的患者报告结局指标得到改善，且处方阿片类药物用量降低。在本次为期6个月的分析中，大多数受试者对CBMPs耐受性良好。未来需通过随机对照试验进一步评估以明确二者的因果关联。