オピオイド使用障害の参加者における不眠症の治療のためのスボレキサント (MK-4305) の研究 (MK-4305-098)
オピオイド使用障害の参加者における不眠症治療におけるスボレキサントの有効性と安全性を評価するための第 3 相多施設共同無作為化二重盲検プラセボ対照試験
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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Toll Free Number
- 電話番号：1-888-577-8839
- メール：Trialsites@msd.com
研究場所
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California
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Garden Grove、California、アメリカ、92845
- 募集
- Cenexel CNS ( Site 2012)
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コンタクト：
- Study Coordinator
- 電話番号：866-787-4257
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Connecticut
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New Haven、Connecticut、アメリカ、06520
- 募集
- Yale University School of Medicine ( Site 1003)
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コンタクト：
- Study Coordinator
- 電話番号：203-785-3627
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Florida
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Bradenton、Florida、アメリカ、34205
- 募集
- Bradenton Research Center ( Site 2021)
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コンタクト：
- Study Coordinator
- 電話番号：941-708-0005
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Georgia
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Savannah、Georgia、アメリカ、31405
- 募集
- CenExel iResearch, LLC ( Site 2010)
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コンタクト：
- Study Coordinator
- 電話番号：912-744-0800
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Maryland
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Baltimore、Maryland、アメリカ、21224
- 募集
- Johns Hopkins University ( Site 1001)
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コンタクト：
- Study Coordinator
- 電話番号：443-216-9237
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New Jersey
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Marlton、New Jersey、アメリカ、08053
- 募集
- Hassman Research Institute Marlton Site ( Site 2005)
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コンタクト：
- Study Coordinator
- 電話番号：856-261-6420
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73112
- 募集
- The Rivus Wellness & Research Institute ( Site 2014)
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コンタクト：
- Study Coordinator
- 電話番号：405-607-2233
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- 募集
- Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)
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コンタクト：
- Study Coordinator
- 電話番号：215-222-3200
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Rhode Island
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Providence、Rhode Island、アメリカ、02906
- 募集
- Butler Hospital ( Site 1002)
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コンタクト：
- Study Coordinator
- 電話番号：401-455-6440
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South Carolina
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Charleston、South Carolina、アメリカ、29403
- 募集
- Medical University of South Carolina ( Site 1005)
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コンタクト：
- Study Coordinator
- 電話番号：843-792-4636
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Texas
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DeSoto、Texas、アメリカ、75115
- 募集
- Adams Clinical Dallas ( Site 2007)
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コンタクト：
- Study Coordinator
- 電話番号：972-283-6286
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Houston、Texas、アメリカ、77043
- 募集
- Memorial Hermann Village ( Site 2001)
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コンタクト：
- Study Coordinator
- 電話番号：281-369-5765
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Virginia
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Richmond、Virginia、アメリカ、23219
- 募集
- VCU Institute for Drug and Alcohol Studies ( Site 1004)
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コンタクト：
- Study Coordinator
- 電話番号：804-827-3784
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
他の名前：
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プラセボコンパレーター：Placebo
Participants receive suvorexant-matching placebo for up to approximately 8 weeks. |
Oral Tablet |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in Total Sleep Time at Week 8
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Medical Director、Merck Sharp & Dohme LLC
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 4305-098
- MK-4305-098 (その他の識別子：MSD)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。