Um estudo de suvorexante (MK-4305) para o tratamento da insônia em participantes com transtorno por uso de opióides (MK-4305-098)
Um estudo de fase 3, multicêntrico, randomizado, duplo-cego e controlado por placebo para avaliar a eficácia e segurança do suvorexante para o tratamento da insônia em participantes com transtorno por uso de opióides
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Toll Free Number
- Número de telefone: 1-888-577-8839
- E-mail: Trialsites@msd.com
Locais de estudo
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California
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Garden Grove, California, Estados Unidos, 92845
- Recrutamento
- Cenexel CNS ( Site 2012)
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Contato:
- Study Coordinator
- Número de telefone: 866-787-4257
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Recrutamento
- Yale University School of Medicine ( Site 1003)
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Contato:
- Study Coordinator
- Número de telefone: 203-785-3627
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Florida
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Bradenton, Florida, Estados Unidos, 34205
- Recrutamento
- Bradenton Research Center ( Site 2021)
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Contato:
- Study Coordinator
- Número de telefone: 941-708-0005
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Georgia
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Savannah, Georgia, Estados Unidos, 31405
- Recrutamento
- CenExel iResearch, LLC ( Site 2010)
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Contato:
- Study Coordinator
- Número de telefone: 912-744-0800
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Recrutamento
- Johns Hopkins University ( Site 1001)
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Contato:
- Study Coordinator
- Número de telefone: 443-216-9237
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New Jersey
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Marlton, New Jersey, Estados Unidos, 08053
- Recrutamento
- Hassman Research Institute Marlton Site ( Site 2005)
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Contato:
- Study Coordinator
- Número de telefone: 856-261-6420
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73112
- Recrutamento
- The Rivus Wellness & Research Institute ( Site 2014)
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Contato:
- Study Coordinator
- Número de telefone: 405-607-2233
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Recrutamento
- Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)
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Contato:
- Study Coordinator
- Número de telefone: 215-222-3200
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02906
- Recrutamento
- Butler Hospital ( Site 1002)
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Contato:
- Study Coordinator
- Número de telefone: 401-455-6440
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29403
- Recrutamento
- Medical University of South Carolina ( Site 1005)
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Contato:
- Study Coordinator
- Número de telefone: 843-792-4636
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Texas
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DeSoto, Texas, Estados Unidos, 75115
- Recrutamento
- Adams Clinical Dallas ( Site 2007)
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Contato:
- Study Coordinator
- Número de telefone: 972-283-6286
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Houston, Texas, Estados Unidos, 77043
- Recrutamento
- Memorial Hermann Village ( Site 2001)
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Contato:
- Study Coordinator
- Número de telefone: 281-369-5765
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Virginia
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Richmond, Virginia, Estados Unidos, 23219
- Recrutamento
- VCU Institute for Drug and Alcohol Studies ( Site 1004)
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Contato:
- Study Coordinator
- Número de telefone: 804-827-3784
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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
Outros nomes:
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Comparador de Placebo: Placebo
Participants receive suvorexant-matching placebo for up to approximately 8 weeks. |
Oral Tablet |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in Total Sleep Time at Week 8
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 4305-098
- MK-4305-098 (Outro identificador: MSD)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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