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办公室美沙酮与丁丙诺啡对比解决阿片类药物使用障碍治疗药物保留问题。

2026年9月9日 更新者：Yale University

办公室美沙酮与丁丙诺啡比较解决阿片类药物使用障碍治疗药物保留问题 - 一项务实的混合有效性/实施试验

该临床试验的目的是比较办公室美沙酮与药房给药和/或配药办公室丁丙诺啡治疗阿片类药物使用障碍的有效性。 这项研究还将探讨影响办公室美沙酮实施的因素。

研究概览

地位

招聘中

条件

干预/治疗

详细说明

本研究是一项随机、务实的混合型 1 型有效性/实施多中心（约 6 个中心）试验，旨在确定在诊所使用美沙酮配药和/或配药或丁丙诺啡 (BUP) 是否会在约 600 名阿片类药物患者中提高治疗保留率使用障碍（OUD）。 该试验还将确定患者、提供者和卫生系统层面对办公室美沙酮药房管理和/或配药的实施障碍、促进因素和可接受性。

研究类型

介入性

注册 (估计的)

600

阶段

  • 第四阶段

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。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • California
      • Oakland、California、美国、94602
        • 招聘中
        • Highland Hospital Bridge Clinic at Alameda Health System
        • 首席研究员：
          • Monish Ullal, MD
        • 接触：
      • San Francisco、California、美国、94103
        • 招聘中
        • Outpatient Buprenorphine Induction Clinic, University of California, San Francisco
        • 首席研究员：
          • Paula Lum, MD
        • 首席研究员：
          • Andy Tompkins, MD
        • 副研究员：
          • Christine Soran, MD
        • 接触：
    • Colorado
      • Denver、Colorado、美国、80205
        • 招聘中
        • Rapid Start Clinic, Kaiser Permanente Colorado
        • 首席研究员：
          • Ingrid Binswanger, MD
        • 接触：
          • Jennifer Barrow
          • 电话号码：(303)-739-3666
          • 邮箱：EMBOSS@kp.org
    • Massachusetts
      • Boston、Massachusetts、美国、02118
        • 招聘中
        • Officed Based Addiction Treatment Program, Boston Medical Center
        • 首席研究员：
          • Zoe Weinstein, MD
        • 接触：
    • Minnesota
      • Minneapolis、Minnesota、美国、55415
        • 招聘中
        • Hennepin Healthcare Addiction Medicine
        • 首席研究员：
          • Gavin Bart, MD
        • 接触：
    • West Virginia
      • Huntington、West Virginia、美国、25703
        • 招聘中
        • Marshall University Division of Addiction Sciences P.R.O.A.C.T
        • 首席研究员：
          • Zachary Hansen, MD
        • 副研究员：
          • Todd Davies, PhD
        • 接触：

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准

  • 18 岁或以上；
  • 符合《精神障碍诊断与统计手册》第 5 版 (DSM-5) OUD 标准；
  • 正在开始新的 MOUD 治疗

排除标准

  • 在随机分组之前的 7 天内，已开出（并摄入）或服用 MOUD 超过 72 小时，作为新 OUD 治疗事件的“桥梁”。 此类 MOUD 可能包括处方（和摄入）或医疗管理戒断（又称戒毒）。
  • 美沙酮或 BUP 的已知禁忌症
  • 如果在筛查评估中通过尿液人绒毛膜促性腺激素 (hCG) 检测确定怀孕，则不愿意寻求或继续产前护理或妊娠咨询
  • 有自杀倾向或严重认知障碍（例如痴呆、未经治疗的精神病），无法获得现场临床医生确定的知情同意书
  • 目前存在严重的共病物质使用障碍，需要由现场临床医生确定的住院或住院治疗服务
  • 无法或不愿意提供可靠的定位信息，包括除他们自己之外的 2 个或更多联系人
  • 不愿意遵循研究程序（例如，不愿意接受现场临床医生的治疗、使用研究药房、不愿意被随机分配到 BUP 或美沙酮，或者无法进行后续评估），包括允许研究人员访问他们的记录参与 EMR 和州处方药监测计划
  • 之前已注册过 CTN-0131
  • 目前正在参加另一项与研究程序相冲突的研究
  • 目前正在看守所、监狱或法院要求的其他过夜设施中，或有可能阻止参加研究活动的未决法律诉讼
  • 根据站点 PI 或其指定人员的决定，无法用英语进行研究评估。

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
实验性的：办公室美沙酮
根据缉毒局 (DEA) 的特殊例外情况，临床医生会开美沙酮处方，并在药房给予和/或配发口服美沙酮，药房也有例外情况。 所有随机对照试验 (RCT) 参与者都接受额外的行为治疗（例如个人、团体、远程医疗、基于电话的治疗）。
药品：美沙酮

药物：美沙酮

可能的配方：

10和50毫克平板电脑
有源比较器：基于办公室的丁丙诺啡 (BUP)
临床医生开出在药房配发或在办公室施用的 BUP 制剂（例如缓释制剂）。 所有 RCT 参与者都接受额外的行为治疗（例如个人、团体、远程医疗、电话治疗）。
药品：Buprenorphine (BUP)

Drug: Buprenorphine (BUP)

Possible formulations:

A. Buprenorphine, 225 mcg to 24 mg, 225 mcg to 32 mg per day,

B. Buprenorphine (Extended release), 300 mg q 28 days (Sublocade), 100 mg q 28 days (Sublocade), 8 mg q 7 days (Brixadi), 16 mg q 7 days (Brixadi), 24 mg q 7 days (Brixadi), 32 mg q 7 days (Brixadi), 64 mg q 28 days (Brixadi), 96 mg q 28 days (Brixadi), 128 mg q 28 days (Brixadi),

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
Number of days of continuous treatment with site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants.
大体时间：up to Day 168
This measure is based on PDMP data for methadone and non-injectable buprenorphine and EMR data for injectable buprenorphine formulations
up to Day 168

次要结果测量

结果测量
措施说明
大体时间
参与者对 MOUD 的满意度
大体时间：直至第 168 天
在计划于第 28 天收集的评估中报告称，他们所接受的药物在 MOUD 提供者满意度量表工具上至少“有一定帮助”的 RCT 参与者比例。
直至第 168 天
参与者自我报告的用药过量事件总数与危险天数的比率。
大体时间：直至第 168 天
过量日历召回工具收集过量事件。
直至第 168 天
Number of self-reported continuous treatment days in any FDA-approved formulation of MOUD treatment during the 168 days post-randomization.
大体时间：up to Day 168
This measure is assessed using the MOUD Calendar Based Recall Recall Instruments.
up to Day 168
Number of self-reported continuous treatment days in formal OUD treatment, according to American Society of Addiction Medicine (ASAM) levels of care 1-4, during the 168 days post-randomization.
大体时间：up to Day 168

This measure is assessed using one or more of the following:

The Health Services Utilization instrument, a brief structured interview regarding health care utilization (inpatient and outpatient) collecting information on the type and amount of services received, Timeline Followback Medications, MOUD Calendar Based Recall, and Treatment Dates instruments.
up to Day 168
Total number of days receiving any FDA-approved MOUD formulation during the 168 days post-randomization.
大体时间：up to Day 168
This measure is assessed using EMR (for injectable MOUD formulations) and PDMP data.
up to Day 168
The longest duration of continuous treatment episode with MOUD, as randomized, during the 168 days post randomization.
大体时间：up to Day 168
This measure is based on PDMP and/or EMR data.
up to Day 168
Total number of days receiving methadone or buprenorphine, during the 168 days post-randomization.
大体时间：up to Day 168
This measure is assessed using EMR (for injectable MOUD formulations) and PDMP data.
up to Day 168
Total number of days of self-reported non-prescribed opioid use during each 28-day assessment period.
大体时间：up to Day 168
This measure is assessed by the Opioid Use Calendar Based Recall instruments.
up to Day 168
Total number of days of self-reported non-prescribed stimulant use during each 28-day assessment period.
大体时间：up to Day 168
This measure is assessed by the Timeline Followback instrument.
up to Day 168
Total number of days of self-reported non-prescribed benzodiazepine use during each 28-day assessment period.
大体时间：up to Day 168
This measure is assessed by the Timeline Followback instrument.
up to Day 168
Urine toxicology
大体时间：up to Day 168
Total number of monthly (28 days) urines negative for non-prescribed opioids during the 168 days post-randomization. Non-prescribed opioids will be determined using the Opioid Use Calendar Based Recall instrument.
up to Day 168
Total number of self-reported injection drug use related events during each 28-day assessment period.
大体时间：Up to Day 168
Assessment of Infectious or Other Complications of Injection Drug Use assess for skin abscesses, ulcers , cellulitis, osteoarticular septic arthritis, osteomyelitis, epidural infection , endovascular, new injection-related viral infections diagnosis of Hepatitis or HIV.
Up to Day 168
Mean score Pain measured using Pain, Enjoyment of Life and General Activity (PEG) Scale (PEG-3)
大体时间：Up to Day 168
Mean scores on the PEG-3 instrument over time. The PEG-3 instrument is collected every 28 days. The mean score is the average of the three 0-10 rated items. Total score range 0-10. Higher scores indicate worse pain.
Up to Day 168
Total number of self-reported days with acute care utilization (ED or hospitalization) during each 28-day assessment period.
大体时间：Up to Day 168
The Health Services Utilization instrument is a brief, structured interview regarding health care utilization (inpatient and outpatient) collecting information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment) and self-help sources of support (e.g., NA). Also assessed are receipt of formal and informal addiction and mental health treatment services RCT participants might have received outside the study interventions.
Up to Day 168
Total number of behavioral counseling service visits attended per participant during each 28-day assessment period.
大体时间：Up to Day 168
Assessed by EMR extraction and the Health Services Utilization.
Up to Day 168
Total number of planned prescriber visits attended during each 28-day assessment period.
大体时间：Up to Day 168
Assessed by EMR extraction.
Up to Day 168
Pharmacist practice fidelity
大体时间：Up to Day 168
Assessed by MOUD Visit Checklist completion over time. The MOUD Visit Checklist collects clinical activities that might be performed by a pharmacist at each pharmacy, such as performing medication reconciliation; conducting safety assessments, adverse effects of methadone, recent overdose events, checking the patient's controlled medications prescription status using the PDMP before dispensing methadone; providing patient education/counseling; communicating with the clinician regarding any concern; and administering one methadone dose at the pharmacy and/or dispensing methadone according to the prescription.
Up to Day 168

其他结果措施

结果测量
措施说明
大体时间
Retention in office-based methadone treatment
大体时间：Starting at day 168 post enrollment up to 2years
Retention will be defined as the number of days of continuous office-based methadone treatment (time to event outcome) staring at day 168. Discontinuation of methadone for the extended study component will be defined as more than a self-reported 30-day gap in receipt of methadone or non-response on two consecutive 60-day assessments. The date of discontinuation will be the end of the last 30-day period with any self-reported office-based methadone treatment. Participants who remain in continuous treatment through the end of the study and will be censored on day of the last 60 day assessment. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Percentage of days covered of self-reported pharmacy dispensed methadone treatment
大体时间：starting at day 168 post enrollment up to 2 years
Percentage of days covered of self-reported pharmacy dispensed methadone treatment (i.e., number of self-reported days covered per total days observed). Only collected in extended study participants.
starting at day 168 post enrollment up to 2 years
Total number of self-reported overdose events
大体时间：Starting at day 168 post enrollment up to 2years
To assess overdose events, participants will self-report the number of overdose events in the past 28 days. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Methadone dose
大体时间：Starting at day 168 post enrollment up to 2years
Participants will self-report the most recent daily dose (in milligrams) of methadone prescribed and obtained from the pharmacy. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Days of treatment
大体时间：Starting at day 168 post enrollment up to 2years
Days of treatment will be the count of self-reported number of days the participant self reported taking prescribed methadone. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Treatment Effectiveness Assessment (TEA)
大体时间：Starting at day 168 post enrollment up to 2years
The TEA collects self-report data across four domains: substance use, health, lifestyle, and community. This will be analyzed as a repeated measure of overall numerical score. Total score range 4-40. higher scores mean greater improvement. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Health service utilization
大体时间：Starting at day 168 post enrollment up to 2years
Participants will be asked to report the inpatient and outpatient services they used in the past 28 days. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Health related quality of life
大体时间：Starting at day 168 post enrollment up to 2years
To assess health related quality of life, participants will self-report their general health, physical health, and mental health during the past 28 days. This will be analyzed as a repeated measure of overall numerical score. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Crime and criminal justice involvement
大体时间：Starting at day 168 post enrollment up to 2years
To assess crime and criminal justice, participants will self-report how many days in the past 60 days they have been incarcerated, if they have been in contact with the court, criminal justice system, or probation/parole officer and how many of those days in the past 60 they were incarcerated, in contact with the court, criminal justice system or probation/parole officer. Criminal justice involvement will be defined as the percentage of days of self-reported involvement (i.e., number of self-reported days per total days observed). Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
End of study status
大体时间：Starting at day 168 post enrollment up to 2years
End of study status for participants which includes; office-based methadone treatment at end of study, withdrew consent, deceased, unable to contact, no longer being prescribed methadone from the site. End of study status will be reported by study site Research Associates or Site Clinicians. Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years
Substance use
大体时间：Starting at day 168 post enrollment up to 2years
To assess substance use, participants will self-report how many of the past 60 days that they used a substance. Monthly substance use obtained through survey assessment at each 60- day assessment. Total number of days of self-reported substance use during each 60 day assessment period (discrete or continuous outcome, repeated measure). Only collected in extended study participants.
Starting at day 168 post enrollment up to 2years

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。

赞助

Yale University

合作者

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
University of California, San Francisco
Kaiser Permanente
The Emmes Company, LLC
Hennepin Healthcare Research Institute
Alameda Health System
Boston Medical Center (BMC)
Marshall Health

调查人员

  • 首席研究员：David Fiellin, MD、Yale University

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)

2024年6月4日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2023年3月13日

首先提交符合 QC 标准的

2024年3月14日

首次发布 (实际的)

2024年3月21日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月9日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2000033271
  • CTN-0131 (其他标识符：Clinical Trials Network)
  • 5UG1DA015831-21 (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

国家药物滥用研究所 (NIDA) 数据共享网站是一个电子环境，允许将已完成的临床试验的数据分发给研究人员和公众，以促进新研究、鼓励进一步分析并向社区传播信息。 数据共享产生的二次分析使原始研究的科学贡献倍增。 NIH 期望并支持及时发布和共享 NIH 支持的研究的最终研究数据，供其他研究人员使用，以加快将研究成果转化为知识、产品和程序，以改善人类健康。

IPD 共享时间框架

数据集将在 (1) 主要论文被接受发表，或 (2) 数据锁定超过 18 个月（以先到者为准）后可用。

IPD 共享访问标准

民众

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

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.

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