Badanie dotyczące stosowania suvorexantu (MK-4305) w leczeniu bezsenności u osób cierpiących na zaburzenia związane z używaniem opioidów (MK-4305-098)
Wieloośrodkowe, randomizowane badanie III fazy z podwójnie ślepą próbą i grupą kontrolną placebo oceniające skuteczność i bezpieczeństwo stosowania suvoreksantu w leczeniu bezsenności u osób cierpiących na zaburzenia związane z używaniem opioidów
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.
Przegląd badań
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 3
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Toll Free Number
- Numer telefonu: 1-888-577-8839
- E-mail: Trialsites@msd.com
Lokalizacje studiów
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California
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Garden Grove, California, Stany Zjednoczone, 92845
- Rekrutacyjny
- Cenexel CNS ( Site 2012)
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Kontakt:
- Study Coordinator
- Numer telefonu: 866-787-4257
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Connecticut
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New Haven, Connecticut, Stany Zjednoczone, 06520
- Rekrutacyjny
- Yale University School of Medicine ( Site 1003)
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Kontakt:
- Study Coordinator
- Numer telefonu: 203-785-3627
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Florida
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Bradenton, Florida, Stany Zjednoczone, 34205
- Rekrutacyjny
- Bradenton Research Center ( Site 2021)
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Kontakt:
- Study Coordinator
- Numer telefonu: 941-708-0005
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Georgia
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Savannah, Georgia, Stany Zjednoczone, 31405
- Rekrutacyjny
- CenExel iResearch, LLC ( Site 2010)
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Kontakt:
- Study Coordinator
- Numer telefonu: 912-744-0800
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21224
- Rekrutacyjny
- Johns Hopkins University ( Site 1001)
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Kontakt:
- Study Coordinator
- Numer telefonu: 443-216-9237
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New Jersey
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Marlton, New Jersey, Stany Zjednoczone, 08053
- Rekrutacyjny
- Hassman Research Institute Marlton Site ( Site 2005)
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Kontakt:
- Study Coordinator
- Numer telefonu: 856-261-6420
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Oklahoma
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73112
- Rekrutacyjny
- The Rivus Wellness & Research Institute ( Site 2014)
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Kontakt:
- Study Coordinator
- Numer telefonu: 405-607-2233
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Rekrutacyjny
- Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)
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Kontakt:
- Study Coordinator
- Numer telefonu: 215-222-3200
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Rhode Island
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Providence, Rhode Island, Stany Zjednoczone, 02906
- Rekrutacyjny
- Butler Hospital ( Site 1002)
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Kontakt:
- Study Coordinator
- Numer telefonu: 401-455-6440
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South Carolina
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Charleston, South Carolina, Stany Zjednoczone, 29403
- Rekrutacyjny
- Medical University of South Carolina ( Site 1005)
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Kontakt:
- Study Coordinator
- Numer telefonu: 843-792-4636
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Texas
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DeSoto, Texas, Stany Zjednoczone, 75115
- Rekrutacyjny
- Adams Clinical Dallas ( Site 2007)
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Kontakt:
- Study Coordinator
- Numer telefonu: 972-283-6286
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Houston, Texas, Stany Zjednoczone, 77043
- Rekrutacyjny
- Memorial Hermann Village ( Site 2001)
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Kontakt:
- Study Coordinator
- Numer telefonu: 281-369-5765
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Virginia
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Richmond, Virginia, Stany Zjednoczone, 23219
- Rekrutacyjny
- VCU Institute for Drug and Alcohol Studies ( Site 1004)
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Kontakt:
- Study Coordinator
- Numer telefonu: 804-827-3784
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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
Inne nazwy:
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Komparator placebo: Placebo
Participants receive suvorexant-matching placebo for up to approximately 8 weeks. |
Oral Tablet |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from Baseline in Total Sleep Time at Week 8
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Medical Director, Merck Sharp & Dohme LLC
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 4305-098
- MK-4305-098 (Inny identyfikator: MSD)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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