오피오이드 사용 장애(MK-4305-098) 참가자의 불면증 치료를 위한 Suvorexant(MK-4305) 연구
오피오이드 사용 장애가 있는 참가자의 불면증 치료를 위한 Suvorexant의 효능과 안전성을 평가하기 위한 3상, 다기관, 무작위, 이중 맹검, 위약 대조 연구
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Toll Free Number
- 전화번호: 1-888-577-8839
- 이메일: Trialsites@msd.com
연구 장소
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California
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Garden Grove, California, 미국, 92845
- 모병
- Cenexel CNS ( Site 2012)
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연락하다:
- Study Coordinator
- 전화번호: 866-787-4257
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Connecticut
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New Haven, Connecticut, 미국, 06520
- 모병
- Yale University School of Medicine ( Site 1003)
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연락하다:
- Study Coordinator
- 전화번호: 203-785-3627
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Florida
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Bradenton, Florida, 미국, 34205
- 모병
- Bradenton Research Center ( Site 2021)
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연락하다:
- Study Coordinator
- 전화번호: 941-708-0005
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Georgia
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Savannah, Georgia, 미국, 31405
- 모병
- CenExel iResearch, LLC ( Site 2010)
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연락하다:
- Study Coordinator
- 전화번호: 912-744-0800
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Maryland
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Baltimore, Maryland, 미국, 21224
- 모병
- Johns Hopkins University ( Site 1001)
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연락하다:
- Study Coordinator
- 전화번호: 443-216-9237
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New Jersey
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Marlton, New Jersey, 미국, 08053
- 모병
- Hassman Research Institute Marlton Site ( Site 2005)
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연락하다:
- Study Coordinator
- 전화번호: 856-261-6420
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73112
- 모병
- The Rivus Wellness & Research Institute ( Site 2014)
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연락하다:
- Study Coordinator
- 전화번호: 405-607-2233
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- 모병
- Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)
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연락하다:
- Study Coordinator
- 전화번호: 215-222-3200
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Rhode Island
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Providence, Rhode Island, 미국, 02906
- 모병
- Butler Hospital ( Site 1002)
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연락하다:
- Study Coordinator
- 전화번호: 401-455-6440
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South Carolina
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Charleston, South Carolina, 미국, 29403
- 모병
- Medical University of South Carolina ( Site 1005)
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연락하다:
- Study Coordinator
- 전화번호: 843-792-4636
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Texas
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DeSoto, Texas, 미국, 75115
- 모병
- Adams Clinical Dallas ( Site 2007)
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연락하다:
- Study Coordinator
- 전화번호: 972-283-6286
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Houston, Texas, 미국, 77043
- 모병
- Memorial Hermann Village ( Site 2001)
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연락하다:
- Study Coordinator
- 전화번호: 281-369-5765
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Virginia
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Richmond, Virginia, 미국, 23219
- 모병
- VCU Institute for Drug and Alcohol Studies ( Site 1004)
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연락하다:
- Study Coordinator
- 전화번호: 804-827-3784
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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
다른 이름들:
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위약 비교기: Placebo
Participants receive suvorexant-matching placebo for up to approximately 8 weeks. |
Oral Tablet |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Total Sleep Time at Week 8
기간: 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)
기간: 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)
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 4305-098
- MK-4305-098 (기타 식별자: MSD)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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