医用大麻和处方阿片类药物逐渐减少慢性非癌性疼痛患者疼痛和阿片类药物剂量支持的评价
2026年5月28日 更新者：Jodi Gilman、Massachusetts General Hospital
本研究将使用随机对照设计来测试成人使用高剂量慢性阿片类药物治疗 (COT) 治疗慢性非癌症疼痛的医用大麻是否与减少阿片类药物剂量和改善疼痛强度以及添加到 24-周行为干预（POTS）。
研究概览
详细说明
该试验是一项为期六个月的随机研究，研究医用大麻 (MM) 对阿片类药物的使用，将：(1) 评估在 COT 上患有慢性非癌性疼痛的成年人是否被分配到 MM+POTS，与那些被分配到 WL+ 的人相比POTS，在阿片类药物剂量和/或疼痛强度和干扰方面有更大的减少，(2) 评估分配到 MM+POTS 的参与者与分配到 WL+POTS 的参与者相比，是否改善了生活质量、抑郁和焦虑；和减少自我报告的阿片类药物剂量，(3) 评估那些分配给 MM+POTS 的人是否在 24 周的干预期间以及在 12 个月的时间点出现 CUD 症状并且 OUD 症状数量减少。
参与者将被随机分配到活跃的 MM 臂 (n = 125) 或候补控制臂 (WLC) (n = 125)。 参与者将在基线时接受评估，每 4 周一次，持续 6 个月，并在 12 个月的随访中评估阿片类药物的使用、CUD 的发展、OUD 的发展或解决以及神经认知表现。 收集的尿液将通过定量分析进行评估。
研究类型
介入性
注册 (实际的)
87
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Maine
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Portland、Maine、美国、04102
- Maine Medical Center
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Massachusetts
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Boston、Massachusetts、美国、02114-2523
- Massachusetts General Hospital
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Cambridge、Massachusetts、美国、02139
- Cambridge Health Alliance
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
14年 至 71年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 年龄在 18-75 岁（含）之间的男性和女性。
- 认可 > 6 个月的慢性非癌症疼痛。
- 处方阿片类药物处方剂量稳定在 25 MME 或更高，持续时间 > 90 天，经处方监测计划验证。
- 以前没有使用过或目前使用过少量大麻（在过去 12 个月内每周或更少）。
- 计划使用医用大麻止痛以控制疼痛和/或减少阿片类药物剂量。
- 有能力并愿意提供英文的书面知情同意书。
- 有生育能力的潜在参与者必须在入组时进行尿妊娠试验阴性，并同意使用有效的避孕措施：禁欲；荷尔蒙避孕药；宫内节育器，绝育；或双重屏障避孕，在研究期间。
排除标准：
- 通过自我报告评估（过去 90 天内不超过 10 次），在过去 12 个月内平均每周使用大麻（包括吸入或摄入的 CBD 产品）。
- 当前的大麻使用障碍；目前通过结构化访谈了解任何物质的中度至重度物质使用障碍，尼古丁和阿片类药物 (OUD) 除外。
- 当前无法控制的重大疾病，例如癌症、症状性甲状腺功能减退症/甲状腺功能亢进症或严重的呼吸系统疾病。
- 通过自我报告使用非处方阿片类药物。
- 在过去 4 周内改变剂量或开始服用具有显着镇痛作用的药物（例如三环类抗抑郁药、SSRIs、加巴喷丁、NSAIDs）。
- 每次研究访视时都会讨论合并用药，任何可能与大麻素相互作用的药物（例如华法林）都会在入组或继续参与前与研究临床医生讨论。
- 过去一年有积极的自杀和/或自杀企图或精神病住院治疗，或当前有特定计划或意图的自杀意念。
- 智力障碍（例如唐氏综合症）或其他严重发育障碍或智商 < 70 的病史。
- 目前诊断为谵妄、痴呆、遗忘症或其他认知障碍；目前诊断为双相 II 型障碍； I 型双相情感障碍、精神分裂症谱系或其他精神障碍的终生诊断。
- 在过去一个月内或计划在未来 6 个月内进行手术。
- 怀孕或试图怀孕或哺乳。
- 根据研究者或研究医师的意见，无法完成研究程序或安全地参与本研究。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cannabis (CB)
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately.
Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
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Participants assigned to the cannabis group were allowed to initiate cannabis use immediately.
Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All participants were offered weekly group Prescription Opioid Taper Support (POTS) sessions for 24 weeks.
POTS is behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering.
This intervention was adapted for this trial to include group-based delivery.
Sessions are one hour delivered via teleconference and incorporated cognitive behavioral, mindfulness-based, and motivational interviewing strategies.
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有源比较器：Waitlist (WL)
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks.
All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
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All participants were offered weekly group Prescription Opioid Taper Support (POTS) sessions for 24 weeks.
POTS is behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering.
This intervention was adapted for this trial to include group-based delivery.
Sessions are one hour delivered via teleconference and incorporated cognitive behavioral, mindfulness-based, and motivational interviewing strategies.
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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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Mean Difference in Prescription Monitoring Program Verified Opioid Dose at Baseline and Week 24
大体时间：Week 24
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Median opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day, over monthly interval preceding study visit.
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Week 24
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Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score Over Post-baseline to Week 24 Interval
大体时间：Every post-baseline day until week 24
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The Pain, Enjoyment, General Activity (PEG) scale assesses pain intensity and interference.
The scale ranges from 0 to 10, with a higher score indicating greater pain intensity and interference.
PEG score was assessed daily through week 24 via daily self-report survey.
From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
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Every post-baseline day until week 24
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Difference in Self-Reported Opioid Dose Over Post-baseline to Week 24 Interval
大体时间：Every post-baseline day until week 24
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Self-reported opioid dose in morphine milligram equivalents (MME) per day.
Self-reported opioid dose was assessed daily through week 24 via daily self-report survey.
From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
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Every post-baseline day until week 24
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Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Summed Score at Weeks 4, 8, 12, 16, 20, 24
大体时间：Week 4, week 8, week 12, week 16, week 20, week 24
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Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form assesses changes in quality of life measures.
The scale ranges from 14 - 70, with a lower score indicating greater dissatisfaction with life.
Q-LES-SF score was assessed at weeks 4, 8, 12, 16, 20, and 24.
From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
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Week 4, week 8, week 12, week 16, week 20, week 24
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Mean Difference in PROMIS-29 Depression Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24
大体时间：Week 4, week 8, week 12, week 16, week 20, week 24
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The 8-item depression subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess depression symptoms.
The scale uses a t-score metric (mean of 50, SD of 10).
Higher scores indicate worse depression.
PROMIS-29 depression subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24.
From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
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Week 4, week 8, week 12, week 16, week 20, week 24
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Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24
大体时间：Week 4, week 8, week 12, week 16, week 20, week 24
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The 7-item anxiety subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess anxiety symptoms.
The scale uses a t-score metric (mean of 50, SD of 10).
Higher scores indicate worse anxiety.
PROMIS-29 anxiety subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24.
From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
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Week 4, week 8, week 12, week 16, week 20, week 24
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Mean Difference in Opioid Use Disorder Symptoms at Weeks 4, 8, 12, 16, 20, 24
大体时间：Week 4, week 8, week 12, week 16, week 20, week 24
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Number of opioid use disorder (OUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist.
As all participants were taking prescribed opioids under the supervision of a clinician, symptom counts exclude tolerance and withdrawal.
Number of symptoms range from 0 to 9. A score of 2 or more indicates a current opioid use disorder diagnosis.
Number of opioid use disorder symptoms were assessed at weeks 4, 8, 12, 16, 20, and 24.
From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
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Week 4, week 8, week 12, week 16, week 20, week 24
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Mean Difference in Cannabis Use Disorder Symptoms at Weeks 12 and 24
大体时间：Week 12, Week 24
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Number of cannabis use disorder (CUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist.
Number of symptoms range from 0 to 11.
A score of 2 or more indicates a current cannabis use disorder diagnosis.
The number of cannabis use disorder symptoms were assessed at weeks 12 and 24.
From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
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Week 12, Week 24
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jodi Gilman, PhD、Massachusetts General Hospital
- 首席研究员：A. Eden Evins, MD、Massachusetts General Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年8月23日
初级完成 (实际的)
2025年5月1日
研究完成 (实际的)
2025年10月31日
研究注册日期
首次提交
2021年3月29日
首先提交符合 QC 标准的
2021年3月31日
首次发布 (实际的)
2021年4月1日
研究记录更新
最后更新发布 (实际的)
2026年6月24日
上次提交的符合 QC 标准的更新
2026年5月28日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 2021P000871
- R01DA051540 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
分析中使用的所有数据、代码和材料均可由 Jodi Gilman 和马萨诸塞州总医院提供，等待科学审查，并在结果公布一年后开始提供完整的数据使用协议/材料转让协议。
所有材料的请求都应通过 jgilman1@mgh.harvard.edu 提交给 Jodi Gilman。
IPD 共享时间框架
数据将在结果公布后一年开始提供。
IPD 共享访问标准
在等待科学审查和完成数据使用协议/材料转让协议之前，将提供数据。
应通过 jgilman1@mgh.harvard.edu 将请求提交给 Jodi Gilman
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.