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Suvorexant (MK-4305) 治疗阿片类药物使用障碍 (MK-4305-098) 参与者失眠的研究

2026年9月17日 更新者：Merck Sharp & Dohme LLC

一项 3 期、多中心、随机、双盲、安慰剂对照研究，旨在评估 Suvorexant 治疗阿片类药物使用障碍参与者失眠的疗效和安全性

People with opioid use disorder (OUD) can have trouble falling or staying asleep. Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep. The goal of this study is to learn about the safety of suvorexant and how well people tolerate it. Researchers also want to learn if suvorexant helps people sleep longer compared to people who take placebo. A placebo looks like the study medicine but has no actual study medicine in it.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

300

阶段

  • 第三阶段

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

学习地点

  • 美国
    • California
      • Garden Grove、California、美国、92845
        • 招聘中
        • Cenexel CNS ( Site 2012)
        • 接触：
          • Study Coordinator
          • 电话号码：866-787-4257
    • Connecticut
      • New Haven、Connecticut、美国、06520
        • 招聘中
        • Yale University School of Medicine ( Site 1003)
        • 接触：
          • Study Coordinator
          • 电话号码：203-785-3627
    • Florida
      • Bradenton、Florida、美国、34205
        • 招聘中
        • Bradenton Research Center ( Site 2021)
        • 接触：
          • Study Coordinator
          • 电话号码：941-708-0005
    • Georgia
      • Savannah、Georgia、美国、31405
        • 招聘中
        • CenExel iResearch, LLC ( Site 2010)
        • 接触：
          • Study Coordinator
          • 电话号码：912-744-0800
    • Maryland
      • Baltimore、Maryland、美国、21224
        • 招聘中
        • Johns Hopkins University ( Site 1001)
        • 接触：
          • Study Coordinator
          • 电话号码：443-216-9237
    • New Jersey
      • Marlton、New Jersey、美国、08053
        • 招聘中
        • Hassman Research Institute Marlton Site ( Site 2005)
        • 接触：
          • Study Coordinator
          • 电话号码：856-261-6420
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73112
        • 招聘中
        • The Rivus Wellness & Research Institute ( Site 2014)
        • 接触：
          • Study Coordinator
          • 电话号码：405-607-2233
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • 招聘中
        • Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)
        • 接触：
          • Study Coordinator
          • 电话号码：215-222-3200
    • Rhode Island
      • Providence、Rhode Island、美国、02906
        • 招聘中
        • Butler Hospital ( Site 1002)
        • 接触：
          • Study Coordinator
          • 电话号码：401-455-6440
    • South Carolina
      • Charleston、South Carolina、美国、29403
        • 招聘中
        • Medical University of South Carolina ( Site 1005)
        • 接触：
          • Study Coordinator
          • 电话号码：843-792-4636
    • Texas
      • DeSoto、Texas、美国、75115
        • 招聘中
        • Adams Clinical Dallas ( Site 2007)
        • 接触：
          • Study Coordinator
          • 电话号码：972-283-6286
      • Houston、Texas、美国、77043
        • 招聘中
        • Memorial Hermann Village ( Site 2001)
        • 接触：
          • Study Coordinator
          • 电话号码：281-369-5765
    • Virginia
      • Richmond、Virginia、美国、23219
        • 招聘中
        • VCU Institute for Drug and Alcohol Studies ( Site 1004)
        • 接触：
          • Study Coordinator
          • 电话号码：804-827-3784

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 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has a primary diagnosis of OUD according to Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5), and confirmed through the Mini International Neuropsychiatric Interview (MINI).
  • Is on a verified, stable dose of medications for opioid use disorder (MOUD) treatment.
  • Meets DSM-5 criteria for the diagnosis of Insomnia Disorder
  • Has a regular bedtime between 8 PM (20:00) and 1 AM (01:00) and is willing to maintain it for the duration of the study.
  • Has not used opioids for a period of at least 4 weeks before entering the study.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has current uncontrolled major co-morbid psychiatric illness including major depressive disorder, bipolar disorder, schizophrenia, or any psychiatric condition with psychotic features.
  • Has current diagnosis or history within 5 years of any of the following: narcolepsy, sleep paralysis, severe periodic limb movement disorder, restless leg syndrome, cataplexy, circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, rapid eye movement (REM) behavior disorder, significant degree of sleep-related breathing disorder, excessive daytime sleepiness (EDS), or primary hypersomnia.
  • Is at imminent risk of self-harm.
  • Has a known history of stroke that may confound the diagnosis of insomnia.
  • Has a clinically significant movement disorder such as akinesia.
  • Has a history of hepatitis or live disease.
  • Has habitual use of central nervous system (CNS)-depressants or stimulants that may be responsible for the participant's disturbed sleep.
  • Has a history of malignancy, ≤3 years prior to start of study, with the exception of nonmelanoma skin cancer, prostate cancer or localized carcinoma in situ of the cervix.
  • Has a history of hypersensitivity to more than 3 chemical classes of drugs, including prescription and over-the-counter medications.
  • Has donated blood products or had phlebotomy within 8 weeks prior to start of study.
  • Has a history of transmeridian travel within 2 weeks prior to start of study.

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：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Suvorexant

Participants receive 10 mg of suvorexant for the first three nights, increased to 20 mg of suvorexant nightly thereafter at the investigator's discretion, for up to approximately 8 weeks.
药品：Suvorexant

Oral Tablet

其他名称：
  • MK-4305
安慰剂比较：Placebo

Participants receive suvorexant-matching placebo for up to approximately 8 weeks.
药品：Placebo

Oral Tablet

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
Change from Baseline in Total Sleep Time at Week 8
大体时间：Baseline and Week 8

Total sleep time will be measured in a sleep laboratory by polysomnography at the participant's habitual bedtime. Change from baseline in total sleep time at Week 8 will be reported.
Baseline and Week 8
Number of Participants Who Experience One or More Adverse Events (AEs)
大体时间：Up to approximately 10 weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 10 weeks
Number of Participants Who Experience One or More Serious Adverse Events (SAEs)
大体时间：Up to approximately 10 weeks

An SAE is any untoward medical occurrence that at any dose results in death, is life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect or is another important medical event deemed such by medical or scientific judgement.
Up to approximately 10 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
大体时间：Up to approximately 8 weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 8 weeks

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8
大体时间：Baseline and Week 8

Wakefulness after persistent sleep onset will be measured in a sleep laboratory by polysomnography at the participant's habitual bedtime. Change from baseline in wakefulness after persistent sleep onset at Week 8 will be reported.
Baseline and Week 8
Number of Participants Who are Positive for Substance Abuse at Day 1
大体时间：Day 1

A positive assessment for substance abuse at Day 1 is defined as either a positive urine drug test for opioids and other nonmedical substances including fentanyl, cocaine, amphetamines, benzodiazepines, and cannabis OR a positive response on the Substance Use History (SUH) Since Last Assessment questionnaire. The Substance Use History Questionnaire (SUH) has been developed specifically for this study. This is a self-reported questionnaire used to obtain a variety of quantitative estimates of cannabis, alcohol, and other nonmedical substance use. The SUH Since Last Assessment Questionnaire will be used to assess nonmedical substance and alcohol use since the previous study visit.
Day 1
Number of Participants Who are Positive for Substance Abuse at Day 4
大体时间：Day 4

A positive assessment for substance abuse at Day 4 is defined as either a positive urine drug test for opioids and other nonmedical substances including fentanyl, cocaine, amphetamines, benzodiazepines, and cannabis OR a positive response on the Substance Use History (SUH) Since Last Assessment questionnaire. The Substance Use History Questionnaire (SUH) has been developed specifically for this study. This is a self-reported questionnaire used to obtain a variety of quantitative estimates of cannabis, alcohol, and other nonmedical substance use. The SUH Since Last Assessment Questionnaire will be used to assess nonmedical substance and alcohol use since the previous study visit.
Day 4
Number of Participants Who are Positive for Substance Abuse at Week 2
大体时间：Week 2

A positive assessment for substance abuse at Week 2 is defined as either a positive urine drug test for opioids and other nonmedical substances including fentanyl, cocaine, amphetamines, benzodiazepines, and cannabis OR a positive response on the Substance Use History (SUH) Since Last Assessment questionnaire. The Substance Use History Questionnaire (SUH) has been developed specifically for this study. This is a self-reported questionnaire used to obtain a variety of quantitative estimates of cannabis, alcohol, and other nonmedical substance use. The SUH Since Last Assessment Questionnaire will be used to assess nonmedical substance and alcohol use since the previous study visit.
Week 2
Number of Participants Who are Positive for Substance Abuse at Week 4
大体时间：Week 4

A positive assessment for substance abuse at Week 4 is defined as either a positive urine drug test for opioids and other nonmedical substances including fentanyl, cocaine, amphetamines, benzodiazepines, and cannabis OR a positive response on the Substance Use History (SUH) Since Last Assessment questionnaire. The Substance Use History Questionnaire (SUH) has been developed specifically for this study. This is a self-reported questionnaire used to obtain a variety of quantitative estimates of cannabis, alcohol, and other nonmedical substance use. The SUH Since Last Assessment Questionnaire will be used to assess nonmedical substance and alcohol use since the previous study visit.
Week 4
Number of Participants Who are Positive for Substance Abuse at Week 8
大体时间：Week 8

A positive assessment for substance abuse at Week 8 is defined as either a positive urine drug test for opioids and other nonmedical substances including fentanyl, cocaine, amphetamines, benzodiazepines, and cannabis OR a positive response on the Substance Use History (SUH) Since Last Assessment questionnaire. The Substance Use History Questionnaire (SUH) has been developed specifically for this study. This is a self-reported questionnaire used to obtain a variety of quantitative estimates of cannabis, alcohol, and other nonmedical substance use. The SUH Since Last Assessment Questionnaire will be used to assess nonmedical substance and alcohol use since the previous study visit.
Week 8
Number of Participants with Positive Urine Drug Screen
大体时间：Day 1, Day 4, Week 2, Week 4, Week 8

A positive urine drug screen is defined as urine drug test positive for opioids and other nonmedical substances including fentanyl, cocaine, amphetamines, benzodiazepines, and cannabis
Day 1, Day 4, Week 2, Week 4, Week 8

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

Merck Sharp & Dohme LLC

调查人员

  • 研究主任：Medical Director、Merck Sharp & Dohme LLC

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。

有用的网址

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)

2025年10月9日

初级完成 (估计的)

2027年6月24日

研究完成 (估计的)

2027年6月24日

研究注册日期

首次提交

2024年10月22日

首先提交符合 QC 标准的

2024年10月22日

首次发布 (实际的)

2024年10月24日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 4305-098
  • MK-4305-098 (其他标识符：MSD)

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

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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

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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