医用大麻作为鸦片替代品
在过去的十年中，阿片类药物用于疼痛的使用急剧增加，灾难性的结果导致了美国过量和死亡的流行。 费城被描述为美国阿片类药物过量和死亡的鸦片流行中的“地面零”。 一些最初的临床经验表明，医用大麻可以通过减轻疼痛和改善生活质量，使他们停止鸦片药物，从而有可能帮助患有某些严重医疗状况的患者。
医用大麻非常安全，可以缓解疼痛，以改善患者及其家人的生活质量。 宾夕法尼亚州的医用大麻法于2016年通过，希望这可以减轻鸦片危机。 宾夕法尼亚州的阿片类药物死亡率为每10万人37.9人。 但是，医用大麻不受保险的覆盖，这是一笔不足的费用。 对于一些尝试医用大麻作为替代方案的患者来说，这是一个障碍。 这可能会在照顾慢性疼痛患者方面造成差异。
方法：
招募和包容/排除标准：将从门诊慢性疼痛诊所招募潜在的参与者。 40名同意尝试对阿片类药物进行断奶并有诊断为医用大麻的诊断患者将被选中进行研究。 在这些选定的患者中，治疗的成本是开始医用大麻的主要障碍。 每个参与者将接受尿液药物筛查，使用视觉模拟量表和疼痛质量进行疼痛评估，将使用短的Form-36健康相关质量和McGill疼痛问卷进行评估，该调查表测量了在接受医用大麻以及6个月后的感官，情感和评估疼痛方面的疼痛维度。
每位患者将由经过认证的医生评估患者的医用大麻进行评估。 如果患者有资格获得医用大麻，则下一步是让患者在宾夕法尼亚州医用大麻网站上注册。 在宾夕法尼亚州有资格患者参加医用大麻的患者的医疗状况是肌萎缩性的侧面硬化症，癌症，克罗恩病，多发性硬化症，神经退行性疾病，神经性疾病，慢性或可治不解的神经性疼痛。 在患者注册后，医生还将在网站上对其进行认证。 在患者获得认证后，他们将申请医用大麻卡。 一旦患者收到医用大麻卡，患者将启动阿片类药物断奶计划。 每个患者将制定一个个性化的计划，以断奶的阿片类药物，这是他们的标准护理计划。 患者将去精选的医用大麻药房，并能够选择其医用大麻产品。 Curaleaf医疗大麻药房将有一份患者列表，参与者将能够从大麻产品中进行选择。 医生将每月跟踪患者六个月，并每月评估患者的疼痛水平和医用大麻剂量和阿片类药物剂量。 研究人员还将注意患者副作用，耐受性和症状的任何减少。 在六个月的时间里，医师将重新检查尿液药物筛查，当前疼痛水平并读取McGill疼痛问卷和与健康相关的质量短。 将注意医用大麻剂量和菌株。
研究概览
详细说明
Opioid use for pain has increased drastically over last decade with disastrous results that lead to an epidemic of overdoses and deaths in the United States. Philadelphia has been described as "ground zero" in the opiate epidemic of overdoses and deaths in the United States. Some initial clinical experience shows that medical marijuana can potentially assist patients suffering from certain serious medical conditions by alleviating pain and improving quality of life, allowing them to discontinue opiates.
Medical Cannabis is very safe and a viable option for pain relief to improve patients and their family's quality of life. The medical marijuana law in Pennsylvania was passed in 2016 with the hope that this might alleviate the opiate crisis. The opioid death rate in Pennsylvania was 37.9 per 100,000 people. However, medical cannabis is not covered by insurance and is an out of pocket expense. This has been a barrier to some patients trying medical cannabis as an alternative. This can create a disparity in care of chronic pain patients.
Methods:
Recruitment and inclusion/exclusion criteria: Potential participants will be recruited from an outpatient chronic pain clinic. 40 patients who have agreed to attempt wean down on opioid medication and have a diagnosis which qualifies them for medical marijuana will be selected for the study. In these selected patients cost of the treatment was the main barrier for starting medical cannabis. Each participant will undergo a urine drug screen, a pain assessment using the visual analog scale and pain quality will be assessed using the Short Form-36 health related quality, which measures sensory, affective and evaluative dimensions of pain prior to receiving medical cannabis and then at 5 months.
Each patient will be evaluated by a physician who is certified to evaluate patients for Medical Cannabis. If the patient qualifies for Medical Cannabis the next step is for the patient to register on the state of Pennsylvania medical marijuana website. Medical conditions that qualify patient in the states of Pennsylvania for medical marijuana are Amyotrophic lateral sclerosis, Cancer, Crohn's disease, multiple sclerosis, Neurodegenerative diseases, neuropathies, chronic or intractable pain of neuropathic origin. After the patient registers the physician will also certify them on the website. After the patients are certified they will apply for medical marijuana card. Once the patient receives a medical marijuana card the patient will start an opioid weaning plan. Each patient will have an individualized plan for weaning off their opioids which is their standard care plan. The patient will go to the select medical cannabis dispensary and will be able to choose their medical cannabis product. The Curaleaf medical cannabis dispensary will have a list of patients and participants will be able to choose from the cannabis products. The patient will be followed up monthly for five months by physician and will assess the patient's pain levels and Medical Cannabis doses and opioid doses monthly. The investigators will also note the patient side effects, tolerance and any decrease in symptoms. At five months the physician will recheck a urine drug screen, current pain level and readminister the Short form-36 health related quality. The Medical Cannabis doses and strains will be noted.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19146
- University of Pennsylvania
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
纳入标准：
正在服用慢性阿片类药物治疗疼痛且过去未能断奶的患者。 这些患者还具有诊断，使他们有资格获得医用大麻，并愿意尝试作为阿片类药物的替代品 -
排除标准：精神分裂症的历史急性精神病障碍，获得了携带枪支联邦工作的许可，将其排除在接受医用大麻之外。
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学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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慢性阿片类药物疼痛患者的成本是尝试医用大麻的障碍
慢性阿片类药物患者过去无法断裂阿片类药物，并且无法尝试次要的医用大麻。
符合条件的患者将获得其医用大麻卡认证，并将去药房获得医用大麻。
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我们将监测患者对医用大麻作为阿片类药物的反应。
这将提供给那些否则无法获得费用的干预措施的患者。
我们想证明医用大麻是该患者人群中阿片类药物的更安全替代品
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Mean Numeric Rating Scale at 5 Months From Baseline
大体时间：From enrollment monthly until the end of treatment at 5 months
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The Numeric Rating Scale is measured from Zero which is equivalent to no pain to 10 which indicates the worst possible pain.
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From enrollment monthly until the end of treatment at 5 months
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Change From Baseline to 5 Months in Daily Opioid Use (Morphine Milligram Equivalents)
大体时间：From Baseline to 5 months
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Total daily opioid dose was converted to Morphine Milligram Equivalents (MME) using standard opioid conversion tables.
The value reported represents the mean change in daily MME from baseline to 5 months.
Negative values indicate a reduction in opioid use.
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From Baseline to 5 months
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合作者和调查者
调查人员
- 首席研究员：Franklin E Caldera, DO,MBA、Univeristy of Pennsylvania
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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