Uno studio su Suvorexant (MK-4305) per il trattamento dell'insonnia in partecipanti con disturbo da uso di oppioidi (MK-4305-098)
Uno studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di Suvorexant per il trattamento dell'insonnia in partecipanti con disturbo da uso di oppioidi
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.
Panoramica dello studio
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: Toll Free Number
- Numero di telefono: 1-888-577-8839
- Email: Trialsites@msd.com
Luoghi di studio
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California
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Garden Grove, California, Stati Uniti, 92845
- Reclutamento
- Cenexel CNS ( Site 2012)
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Contatto:
- Study Coordinator
- Numero di telefono: 866-787-4257
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06520
- Reclutamento
- Yale University School of Medicine ( Site 1003)
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Contatto:
- Study Coordinator
- Numero di telefono: 203-785-3627
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Florida
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Bradenton, Florida, Stati Uniti, 34205
- Reclutamento
- Bradenton Research Center ( Site 2021)
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Contatto:
- Study Coordinator
- Numero di telefono: 941-708-0005
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Georgia
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Savannah, Georgia, Stati Uniti, 31405
- Reclutamento
- CenExel iResearch, LLC ( Site 2010)
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Contatto:
- Study Coordinator
- Numero di telefono: 912-744-0800
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Maryland
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Baltimore, Maryland, Stati Uniti, 21224
- Reclutamento
- Johns Hopkins University ( Site 1001)
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Contatto:
- Study Coordinator
- Numero di telefono: 443-216-9237
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New Jersey
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Marlton, New Jersey, Stati Uniti, 08053
- Reclutamento
- Hassman Research Institute Marlton Site ( Site 2005)
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Contatto:
- Study Coordinator
- Numero di telefono: 856-261-6420
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73112
- Reclutamento
- The Rivus Wellness & Research Institute ( Site 2014)
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Contatto:
- Study Coordinator
- Numero di telefono: 405-607-2233
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Reclutamento
- Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)
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Contatto:
- Study Coordinator
- Numero di telefono: 215-222-3200
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02906
- Reclutamento
- Butler Hospital ( Site 1002)
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Contatto:
- Study Coordinator
- Numero di telefono: 401-455-6440
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29403
- Reclutamento
- Medical University of South Carolina ( Site 1005)
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Contatto:
- Study Coordinator
- Numero di telefono: 843-792-4636
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Texas
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DeSoto, Texas, Stati Uniti, 75115
- Reclutamento
- Adams Clinical Dallas ( Site 2007)
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Contatto:
- Study Coordinator
- Numero di telefono: 972-283-6286
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Houston, Texas, Stati Uniti, 77043
- Reclutamento
- Memorial Hermann Village ( Site 2001)
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Contatto:
- Study Coordinator
- Numero di telefono: 281-369-5765
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Virginia
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Richmond, Virginia, Stati Uniti, 23219
- Reclutamento
- VCU Institute for Drug and Alcohol Studies ( Site 1004)
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Contatto:
- Study Coordinator
- Numero di telefono: 804-827-3784
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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
Altri nomi:
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Comparatore placebo: Placebo
Participants receive suvorexant-matching placebo for up to approximately 8 weeks. |
Oral Tablet |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from Baseline in Total Sleep Time at Week 8
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Week 8
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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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC
Pubblicazioni e link utili
Collegamenti utili
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 4305-098
- MK-4305-098 (Altro identificatore: MSD)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informazioni su farmaci e dispositivi, documenti di studio
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