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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 16
- 主要终点
- Change from Baseline in Total Sleep Time at Week 8
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Participants receive suvorexant-matching placebo for up to approximately 8 weeks.
干预措施: Placebo (Drug)
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.
干预措施: Suvorexant (Drug)
结局指标
主要结局
Change from Baseline in Total Sleep Time at Week 8
时间窗: 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.
Number of Participants Who Experience One or More Adverse Events (AEs)
时间窗: 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.
Number of Participants Who Experience One or More Serious Adverse Events (SAEs)
时间窗: 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.
Number of Participants Who Discontinue Study Treatment Due to an AE
时间窗: 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.
次要结局
- Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8(Baseline and Week 8)
- Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8(Baseline and Week 8)
- Number of Participants Who are Positive for Substance Abuse at Day 1(Day 1)
- Number of Participants Who are Positive for Substance Abuse at Day 4(Day 4)
- Number of Participants Who are Positive for Substance Abuse at Week 2(Week 2)
- Number of Participants Who are Positive for Substance Abuse at Week 4(Week 4)
- Number of Participants Who are Positive for Substance Abuse at Week 8(Week 8)
- Number of Participants with Positive Urine Drug Screen(Day 1, Day 4, Week 2, Week 4, Week 8)