Suvorexant
Oral Tablet
MK-4305Loading study record…
Loading study record…
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-08-28
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Oral Tablet
MK-4305Oral Tablet
Eligibility
primary outcomes
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
secondary outcomes
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Publications
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