Studie Suvorexantu (MK-4305) pro léčbu nespavosti u účastníků s poruchou užívání opioidů (MK-4305-098)
Fáze 3, multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie k vyhodnocení účinnosti a bezpečnosti přípravku Suvorexant při léčbě nespavosti u účastníků s poruchou užívání opioidů
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.
Přehled studie
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Toll Free Number
- Telefonní číslo: 1-888-577-8839
- E-mail: Trialsites@msd.com
Studijní místa
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California
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Garden Grove, California, Spojené státy, 92845
- Nábor
- Cenexel CNS ( Site 2012)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 866-787-4257
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Connecticut
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New Haven, Connecticut, Spojené státy, 06520
- Nábor
- Yale University School of Medicine ( Site 1003)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 203-785-3627
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Florida
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Bradenton, Florida, Spojené státy, 34205
- Nábor
- Bradenton Research Center ( Site 2021)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 941-708-0005
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Georgia
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Savannah, Georgia, Spojené státy, 31405
- Nábor
- CenExel iResearch, LLC ( Site 2010)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 912-744-0800
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Maryland
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Baltimore, Maryland, Spojené státy, 21224
- Nábor
- Johns Hopkins University ( Site 1001)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 443-216-9237
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New Jersey
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Marlton, New Jersey, Spojené státy, 08053
- Nábor
- Hassman Research Institute Marlton Site ( Site 2005)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 856-261-6420
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73112
- Nábor
- The Rivus Wellness & Research Institute ( Site 2014)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 405-607-2233
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- Nábor
- Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 215-222-3200
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02906
- Nábor
- Butler Hospital ( Site 1002)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 401-455-6440
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South Carolina
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Charleston, South Carolina, Spojené státy, 29403
- Nábor
- Medical University of South Carolina ( Site 1005)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 843-792-4636
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Texas
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DeSoto, Texas, Spojené státy, 75115
- Nábor
- Adams Clinical Dallas ( Site 2007)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 972-283-6286
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Houston, Texas, Spojené státy, 77043
- Nábor
- Memorial Hermann Village ( Site 2001)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 281-369-5765
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Virginia
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Richmond, Virginia, Spojené státy, 23219
- Nábor
- VCU Institute for Drug and Alcohol Studies ( Site 1004)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 804-827-3784
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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
Ostatní jména:
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Komparátor placeba: Placebo
Participants receive suvorexant-matching placebo for up to approximately 8 weeks. |
Oral Tablet |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from Baseline in Total Sleep Time at Week 8
Časové okno: 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
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Number of Participants Who Experience One or More Adverse Events (AEs)
Časové okno: 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
|
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Number of Participants Who Experience One or More Serious Adverse Events (SAEs)
Časové okno: 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
|
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Number of Participants Who Discontinue Study Treatment Due to an AE
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8
Časové okno: 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
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Number of Participants Who are Positive for Substance Abuse at Day 1
Časové okno: 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
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Number of Participants Who are Positive for Substance Abuse at Day 4
Časové okno: 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
Časové okno: 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
Časové okno: 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
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Number of Participants Who are Positive for Substance Abuse at Week 8
Časové okno: 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
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Number of Participants with Positive Urine Drug Screen
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Medical Director, Merck Sharp & Dohme LLC
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 4305-098
- MK-4305-098 (Jiný identifikátor: MSD)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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