Исследование суворексанта (MK-4305) для лечения бессонницы у участников с расстройством, вызванным употреблением опиоидов (MK-4305-098)
Фаза 3, многоцентровое, рандомизированное, двойное слепое, плацебо-контролируемое исследование для оценки эффективности и безопасности суворексанта для лечения бессонницы у участников с расстройством, вызванным употреблением опиоидов
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.
Обзор исследования
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 3
Контакты и местонахождение
Контакты исследования
- Имя: Toll Free Number
- Номер телефона: 1-888-577-8839
- Электронная почта: Trialsites@msd.com
Места учебы
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California
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Garden Grove, California, Соединенные Штаты, 92845
- Рекрутинг
- Cenexel CNS ( Site 2012)
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Контакт:
- Study Coordinator
- Номер телефона: 866-787-4257
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Connecticut
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New Haven, Connecticut, Соединенные Штаты, 06520
- Рекрутинг
- Yale University School of Medicine ( Site 1003)
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Контакт:
- Study Coordinator
- Номер телефона: 203-785-3627
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Florida
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Bradenton, Florida, Соединенные Штаты, 34205
- Рекрутинг
- Bradenton Research Center ( Site 2021)
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Контакт:
- Study Coordinator
- Номер телефона: 941-708-0005
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Georgia
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Savannah, Georgia, Соединенные Штаты, 31405
- Рекрутинг
- CenExel iResearch, LLC ( Site 2010)
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Контакт:
- Study Coordinator
- Номер телефона: 912-744-0800
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21224
- Рекрутинг
- Johns Hopkins University ( Site 1001)
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Контакт:
- Study Coordinator
- Номер телефона: 443-216-9237
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New Jersey
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Marlton, New Jersey, Соединенные Штаты, 08053
- Рекрутинг
- Hassman Research Institute Marlton Site ( Site 2005)
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Контакт:
- Study Coordinator
- Номер телефона: 856-261-6420
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты, 73112
- Рекрутинг
- The Rivus Wellness & Research Institute ( Site 2014)
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Контакт:
- Study Coordinator
- Номер телефона: 405-607-2233
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- Рекрутинг
- Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)
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Контакт:
- Study Coordinator
- Номер телефона: 215-222-3200
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Rhode Island
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Providence, Rhode Island, Соединенные Штаты, 02906
- Рекрутинг
- Butler Hospital ( Site 1002)
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Контакт:
- Study Coordinator
- Номер телефона: 401-455-6440
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South Carolina
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Charleston, South Carolina, Соединенные Штаты, 29403
- Рекрутинг
- Medical University of South Carolina ( Site 1005)
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Контакт:
- Study Coordinator
- Номер телефона: 843-792-4636
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Texas
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DeSoto, Texas, Соединенные Штаты, 75115
- Рекрутинг
- Adams Clinical Dallas ( Site 2007)
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Контакт:
- Study Coordinator
- Номер телефона: 972-283-6286
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Houston, Texas, Соединенные Штаты, 77043
- Рекрутинг
- Memorial Hermann Village ( Site 2001)
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Контакт:
- Study Coordinator
- Номер телефона: 281-369-5765
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Virginia
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Richmond, Virginia, Соединенные Штаты, 23219
- Рекрутинг
- VCU Institute for Drug and Alcohol Studies ( Site 1004)
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Контакт:
- Study Coordinator
- Номер телефона: 804-827-3784
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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. |
Oral Tablet
Другие имена:
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Плацебо Компаратор: Placebo
Participants receive suvorexant-matching placebo for up to approximately 8 weeks. |
Oral Tablet |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change from Baseline in Total Sleep Time at Week 8
Временное ограничение: Baseline and Week 8
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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
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Number of Participants Who Experience One or More Adverse Events (AEs)
Временное ограничение: Up to approximately 10 weeks
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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
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Number of Participants Who Experience One or More Serious Adverse Events (SAEs)
Временное ограничение: Up to approximately 10 weeks
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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
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Number of Participants Who Discontinue Study Treatment Due to an AE
Временное ограничение: Up to approximately 8 weeks
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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
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8
Временное ограничение: Baseline and Week 8
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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
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Number of Participants Who are Positive for Substance Abuse at Day 1
Временное ограничение: Day 1
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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
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Number of Participants Who are Positive for Substance Abuse at Day 4
Временное ограничение: Day 4
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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
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Number of Participants Who are Positive for Substance Abuse at Week 2
Временное ограничение: Week 2
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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
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Number of Participants Who are Positive for Substance Abuse at Week 4
Временное ограничение: Week 4
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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
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Number of Participants Who are Positive for Substance Abuse at Week 8
Временное ограничение: Week 8
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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
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Number of Participants with Positive Urine Drug Screen
Временное ограничение: Day 1, Day 4, Week 2, Week 4, Week 8
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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
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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Medical Director, Merck Sharp & Dohme LLC
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 4305-098
- MK-4305-098 (Другой идентификатор: MSD)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .