Une étude sur le suvorexant (MK-4305) pour le traitement de l'insomnie chez les participants souffrant de troubles liés à l'usage d'opioïdes (MK-4305-098)
Une étude de phase 3, multicentrique, randomisée, en double aveugle et contrôlée par placebo pour évaluer l'efficacité et l'innocuité du suvorexant pour le traitement de l'insomnie chez les participants souffrant de troubles liés à l'usage d'opioïdes
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Toll Free Number
- Numéro de téléphone: 1-888-577-8839
- E-mail: Trialsites@msd.com
Lieux d'étude
-
-
California
-
Garden Grove, California, États-Unis, 92845
- Recrutement
- Cenexel CNS ( Site 2012)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 866-787-4257
-
-
Connecticut
-
New Haven, Connecticut, États-Unis, 06520
- Recrutement
- Yale University School of Medicine ( Site 1003)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 203-785-3627
-
-
Florida
-
Bradenton, Florida, États-Unis, 34205
- Recrutement
- Bradenton Research Center ( Site 2021)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 941-708-0005
-
-
Georgia
-
Savannah, Georgia, États-Unis, 31405
- Recrutement
- CenExel iResearch, LLC ( Site 2010)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 912-744-0800
-
-
Maryland
-
Baltimore, Maryland, États-Unis, 21224
- Recrutement
- Johns Hopkins University ( Site 1001)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 443-216-9237
-
-
New Jersey
-
Marlton, New Jersey, États-Unis, 08053
- Recrutement
- Hassman Research Institute Marlton Site ( Site 2005)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 856-261-6420
-
-
Oklahoma
-
Oklahoma City, Oklahoma, États-Unis, 73112
- Recrutement
- The Rivus Wellness & Research Institute ( Site 2014)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 405-607-2233
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis, 19104
- Recrutement
- Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 215-222-3200
-
-
Rhode Island
-
Providence, Rhode Island, États-Unis, 02906
- Recrutement
- Butler Hospital ( Site 1002)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 401-455-6440
-
-
South Carolina
-
Charleston, South Carolina, États-Unis, 29403
- Recrutement
- Medical University of South Carolina ( Site 1005)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 843-792-4636
-
-
Texas
-
DeSoto, Texas, États-Unis, 75115
- Recrutement
- Adams Clinical Dallas ( Site 2007)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 972-283-6286
-
Houston, Texas, États-Unis, 77043
- Recrutement
- Memorial Hermann Village ( Site 2001)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 281-369-5765
-
-
Virginia
-
Richmond, Virginia, États-Unis, 23219
- Recrutement
- VCU Institute for Drug and Alcohol Studies ( Site 1004)
-
Contact:
- Study Coordinator
- Numéro de téléphone: 804-827-3784
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
|
|
Comparateur placebo: Placebo
Participants receive suvorexant-matching placebo for up to approximately 8 weeks. |
Oral Tablet |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in Total Sleep Time at Week 8
Délai: 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
|
|
Number of Participants Who Experience One or More Adverse Events (AEs)
Délai: 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
|
|
Number of Participants Who Experience One or More Serious Adverse Events (SAEs)
Délai: 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
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8
Délai: 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
|
|
Number of Participants Who are Positive for Substance Abuse at Day 1
Délai: 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
|
|
Number of Participants Who are Positive for Substance Abuse at Day 4
Délai: Day 4
|
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
|
|
Number of Participants Who are Positive for Substance Abuse at Week 2
Délai: Week 2
|
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
|
|
Number of Participants Who are Positive for Substance Abuse at Week 4
Délai: 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
|
|
Number of Participants Who are Positive for Substance Abuse at Week 8
Délai: 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
|
|
Number of Participants with Positive Urine Drug Screen
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Medical Director, Merck Sharp & Dohme LLC
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 4305-098
- MK-4305-098 (Autre identifiant: MSD)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .