检查为丁丙诺啡患者提供社会心理支持的适应性方法
2024年11月4日 更新者：Public Health Management Corporation
加强基于办公室的丁丙诺啡治疗：一种适应性心理社会方法
本研究的目的是解决关于在办公室环境中为接受丁丙诺啡治疗阿片类药物使用障碍 (OUD) 的患者提供社会心理治疗的最佳方式的重要知识缺口。
该项目将开发和评估一种适应性治疗方法，根据患者在基线和整个护理过程中的个人需求提供干预措施。
适应性干预将结合经过认证的康复专家 (CRS) 和认知行为疗法 (CBT)，这两种干预已广泛用于 OUD 的治疗。
适应性干预的有效性将通过一项随机对照试验 (RCT) 进行评估，该试验将在费城的联邦合格医疗机构 (FQHC) 中进行。
研究概览
详细说明
这项研究将有助于为在基于办公室的阿片类药物治疗 (OBOT) 和丁丙诺啡的背景下提供社会心理治疗的最佳实践提供信息。 我们将使用分阶段的方法来开发和评估一种适应性方法，以提供辅助心理社会治疗，包括由丁丙诺啡提供者进行药物管理以及根据患者的需要与 CRS 和 CBT 联系起来。 该提案的具体目标如下。
目标 1：与我们的多学科团队合作，为 CRS 和 CBT 干预制定具体方案，并根据行为标准建立算法以确定何时应实施每种干预。 作为这一目标的一部分，我们还将制定提供每项干预措施的标准程序，并培训干预人员 [即 CRS 和持牌专业顾问 (LPC)] 以忠实地提供服务。
目标 2：进行一项两组随机研究，以评估适应性干预相对于 TAU 的疗效。 要检查的结果将包括尿液分析确认的阿片类药物使用、基于丁丙诺啡的 OBOT 的保留、生活质量和研究后一年的社会心理功能。
目标 3：对干预措施进行定性评估并为其传播制定战略计划。 我们将与诊所工作人员和相关利益相关者进行焦点小组讨论，以确定适应性干预的实用性和可接受性。 此外，我们将举行一次专家圆桌会议，以确定提高可持续性和加强其他办公室丁丙诺啡项目采用的机制，为战略计划的制定提供信息。
目标 4：为少数民族学生建立临床研究培训计划。 来自历史上少数民族高等教育机构的八名本科生将被选中参加为期 9 个月的实习，期间他们将接受从研究设计到传播的全方位临床研究的全面和务实的培训。
研究类型
介入性
注册 (实际的)
125
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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Pennsylvania
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Philadelphia、Pennsylvania、美国、19121
- Project HOME Stephen J. Klein Wellness Center
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Philadelphia、Pennsylvania、美国、19123
- PHMC Care Clinic
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 在过去 4 周内已在 FQHC 开始针对 OUD 的办公室丁丙诺啡治疗；
- 不需要医疗保健提供者确定的住院护理水平；和
- 能够提供有效的联系方式和知情同意。
排除标准：
- 患者未满 18 岁；
- 共病精神障碍表明需要更深入的住院治疗
- 患者无法提供知情同意书。
基线时醉酒、认知障碍或精神不稳定的个人将不包括在内；但是，如果取消资格的条件消退，它们随后可能会被包括在内。
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：照常治疗 (TAU)
分配到 TAU 病症的参与者将被安排进行丁丙诺啡药物管理预约，并将在 FQHC 接受 OBOT 以及 FQHC 通常提供的辅助心理社会治疗。
该团队将在随后的 MAT 就诊期间继续与患者会面，但频率会降低，但会因地点而异。
MAT 就诊的时间表通常包括在诱导周内进行 3 次门诊就诊，每周 1-2 次就诊直至患者病情稳定，此后每月进行一次。
行为健康临床医生为患者提供支持，讨论 UDS 结果，协助解决围绕恢复和清醒调整的战略问题，并监测患者对 MAT 的参与情况。
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实验性的：适应性干预
分配到适应性干预条件的参与者将根据上述 TAU 的临床方案安排丁丙诺啡药物管理预约。
这种情况下的参与者接受的辅助心理社会治疗包括 (1) 由行为健康专家提供的 CBT 和/或 (2) 由经过认证的康复专家提供的同伴支持。
积极干预期将跨越进入研究后的 3 个月。
积极干预期结束后，参与者将继续收到 TAU。
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分配到适应性干预条件的参与者将根据上述 TAU 的临床协议安排丁丙诺啡药物管理预约。
这种情况下参与者接受的辅助心理社会治疗是 (1) 由行为健康专家提供的 CBT 和/或 (2) 由经过认证的康复专家提供的同伴支持。
主动干预期将跨越研究进入后 3 个月。
参与者将在积极干预期后继续接受 TAU。
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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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尿液分析证实在 3 个月随访时戒除阿片类药物
大体时间：入学后 3 个月
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参与者将在 3 个月的跟进评估中提供尿液样本。
我们将使用 CLIA Waived® 14-Panel 药物测试杯和芬太尼试纸来检测阿片类药物、丁丙诺啡、美沙酮、羟考酮、THC、可卡因、苯丙胺、PCP、甲基苯丙胺、苯二氮卓类药物和巴比妥类药物，以及 MDMD。
尿样将在 RA 的监督下交付，RA 将使用标准程序检测篡改和稀释。
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入学后 3 个月
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尿液分析证实在 6 个月随访时戒除阿片类药物
大体时间：入学后 6 个月
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参与者将在 6 个月的跟进评估中提供尿液样本。
我们将使用 CLIA Waived® 14-Panel 药物测试杯和芬太尼试纸来检测阿片类药物、丁丙诺啡、美沙酮、羟考酮、THC、可卡因、苯丙胺、PCP、甲基苯丙胺、苯二氮卓类药物和巴比妥类药物，以及 MDMD。
尿样将在 RA 的监督下交付，RA 将使用标准程序检测篡改和稀释。
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入学后 6 个月
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尿液分析证实在 9 个月的随访中戒除阿片类药物
大体时间：进入学习后 9 个月
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参加者将在 9 个月的跟进评估中提供尿液样本。
我们将使用 CLIA Waived® 14-Panel 药物测试杯和芬太尼试纸来检测阿片类药物、丁丙诺啡、美沙酮、羟考酮、THC、可卡因、苯丙胺、PCP、甲基苯丙胺、苯二氮卓类药物和巴比妥类药物，以及 MDMD。
尿样将在 RA 的监督下交付，RA 将使用标准程序检测篡改和稀释。
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进入学习后 9 个月
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尿液分析证实在 12 个月的随访中戒除阿片类药物
大体时间：入学后 12 个月
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参与者将在 12 个月的跟进评估中提供尿液样本。
我们将使用 CLIA Waived® 14-Panel 药物测试杯和芬太尼试纸来检测阿片类药物、丁丙诺啡、美沙酮、羟考酮、THC、可卡因、苯丙胺、PCP、甲基苯丙胺、苯二氮卓类药物和巴比妥类药物，以及 MDMD。
尿样将在 RA 的监督下交付，RA 将使用标准程序检测篡改和稀释。
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入学后 12 个月
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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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戒除或减少使用其他（非阿片类）精神活性物质
大体时间：进入研究后 12 个月
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来自 CLIAwaived® 14 面板测试和上述主要结果的芬太尼条的结果将用作该结果的指标。
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进入研究后 12 个月
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在基于丁丙诺啡的 OBOT 中的保留
大体时间：进入研究后 12 个月
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包括预约出勤率、药物和治疗依从性以及治疗的保留和完成。
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进入研究后 12 个月
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生活质量评估
大体时间：进入研究后 12 个月
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生活质量将使用简表 36 (SF-36) 进行测量。
SF-36 是一种自我报告清单，评估与身心健康相关的生活质量的八个维度。
SF-36 已被证明具有很高的可靠性和有效性。
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进入研究后 12 个月
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心理社会功能/多维问题严重性
大体时间：进入研究后 12 个月
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多维问题的严重程度是次要结果，将使用成瘾严重程度指数-Lite (ASI-Lite) 进行衡量。
ASI-Lite 是一种可靠且有效的多维评估，提供反映当前医疗、就业、酒精、毒品、法律、家庭/社会和精神领域问题严重程度的综合分数。
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进入研究后 12 个月
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治疗满意度
大体时间：进入研究后 12 个月
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治疗满意度将使用治疗服务审查 (TSR) 的修改版本来衡量。
TSR 衡量患者的治疗参与度和治疗满意度。
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进入研究后 12 个月
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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：Karen Dugosh, Ph.D.、PHMC
出版物和有用的链接
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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)
2020年9月21日
初级完成 (实际的)
2024年5月31日
研究完成 (实际的)
2024年5月31日
研究注册日期
首次提交
2020年11月5日
首先提交符合 QC 标准的
2020年11月24日
首次发布 (实际的)
2020年12月2日
研究记录更新
最后更新发布 (实际的)
2024年11月6日
上次提交的符合 QC 标准的更新
2024年11月4日
最后验证
2024年11月1日
更多信息
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