A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)

Официальное название

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Suvorexant for the Treatment of Insomnia in Participants With Opioid Use Disorder

Обзор

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.

Вмешательства

• Препарат Suvorexant
  Oral Tablet
• Препарат Placebo
  Oral Tablet

Первичные конечные точки

• Change from Baseline in Total Sleep Time at Week 8 [Срок оценки: Baseline and Week 8]
• Number of Participants Who Experience One or More Adverse Events (AEs) [Срок оценки: Up to approximately 10 weeks]
• Number of Participants Who Experience One or More Serious Adverse Events (SAEs) [Срок оценки: Up to approximately 10 weeks]
• Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 8 weeks]

Вторичные конечные точки (7)

• Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8 [Срок оценки: Baseline and Week 8]
• Number of Participants Who are Positive for Substance Abuse at Day 1 [Срок оценки: Day 1]
• Number of Participants Who are Positive for Substance Abuse at Day 4 [Срок оценки: Day 4]
• Number of Participants Who are Positive for Substance Abuse at Week 2 [Срок оценки: Week 2]
• Number of Participants Who are Positive for Substance Abuse at Week 4 [Срок оценки: Week 4]
• Number of Participants Who are Positive for Substance Abuse at Week 8 [Срок оценки: Week 8]
• Number of Participants with Positive Urine Drug Screen [Срок оценки: Day 1, Day 4, Week 2, Week 4, Week 8]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 11 центров

• Yale University School of Medicine ( Site 1003) — New Haven
• CenExel iResearch, LLC ( Site 2010) — Savannah
• Johns Hopkins University ( Site 1001) — Baltimore
• Hassman Research Institute Marlton Site ( Site 2005) — Marlton
• The Rivus Wellness & Research Institute ( Site 2014) — Oklahoma City
• Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( — Philadelphia
• Butler Hospital ( Site 1002) — Providence
• Medical University of South Carolina ( Site 1005) — Charleston
• … и ещё 3 центра

Идентификаторы

NCT: NCT06655883 · 4305-098 · MK-4305-098

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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