Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06655883 · ClinicalTrials.gov registry record · Phase 3
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
A Phase 3 study of Insomnia, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 10
- Study locations
NCT06655883: Recruiting Phase 3 study of Insomnia, sponsored by Merck Sharp & Dohme.
NCT06655883 is a Phase 3 study of Insomnia that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 300 participants, above the 168-participant average among 151 other Insomnia trials with a reported enrollment target (79% higher). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06655883, a Phase 3 study of Insomnia, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 10
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Suvorexant
Study Locations (10)
Texas
- Adams Clinical Dallas ( Site 2007) - DeSoto
- Memorial Hermann Village ( Site 2001) - Houston
Connecticut
- Yale University School of Medicine ( Site 1003) - New Haven
Georgia
- CenExel iResearch, LLC ( Site 2010) - Savannah
Maryland
- Johns Hopkins University ( Site 1001) - Baltimore
New Jersey
- Hassman Research Institute Marlton Site ( Site 2005) - Marlton
Oklahoma
- The Rivus Wellness & Research Institute ( Site 2014) - Oklahoma City
Pennsylvania
- Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006) - Philadelphia
Rhode Island
- Butler Hospital ( Site 1002) - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-10-09 |
| Est. Completion | 2027-06-24 |
| Phase | Phase 3 |
What NCT06655883 shows while recruiting
NCT06655883 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 168-participant average among 151 other Insomnia trials with a reported enrollment target (79% higher).
The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06655883 lists 10 locations in 9 states (Texas, Connecticut, Georgia).
Frequently Asked Questions
What is clinical trial NCT06655883 about?
NCT06655883 is a clinical study titled "A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)". 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 ...
What is the current status of trial NCT06655883?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2025-10-09. Estimated completion is 2027-06-24.
What conditions does trial NCT06655883 study?
This clinical trial studies the following conditions: Insomnia.
What interventions are being tested in trial NCT06655883?
The interventions under investigation include: Placebo (DRUG), Suvorexant (DRUG).
Who is sponsoring clinical trial NCT06655883?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06655883 being conducted?
This trial has 10 study locations across Connecticut, Georgia, Maryland, New Jersey, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06655883's enrollment target sits among peer trials
300 24th of 151 higher than 127 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
National Adaptive Trial for PTSD Related Insomnia
ACTIVE NOT RECRUITING · Phase 3
-
Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia
COMPLETED · Phase 3
-
Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
COMPLETED · Phase 3
-
A Study of Eszopiclone in Subjects With Insomnia Related to Major Depressive Disorder
COMPLETED · Phase 3
-
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
RECRUITING
-
Sleep to Reduce Incident Depression Effectively in Peripartum
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00353483 · 300 participants
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
- NCT00588185 · 300 participants · NA
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
- NCT00682032 · 300 participants · NA
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
- NCT00870064 · 300 participants · NA
The Treatment of Type I Open Fractures in Pediatrics
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI