A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06655883
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Suvorexant — DRUG
    Oral Tablet
  • Placebo — DRUG
    Oral Tablet

Study Details

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.

Key Dates

Start date
Oct 9, 2025
Status verified
May 2026
Primary completion
Jun 24, 2027
Completion
Jun 24, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: Placebo
    Participants receive suvorexant-matching placebo for up to approximately 8 weeks.

Primary Outcome Measure

Change from Baseline in Total Sleep Time at Week 8 [ Time Frame: Baseline and Week 8 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Yale University School of Medicine ( Site 1003)New HavenConnecticut06520
Study Coordinator
203-785-3627
CenExel iResearch, LLC ( Site 2010)SavannahGeorgia31405
Study Coordinator
912-744-0800
Johns Hopkins University ( Site 1001)BaltimoreMaryland21224
Study Coordinator
443-216-9237
Hassman Research Institute Marlton Site ( Site 2005)MarltonNew Jersey08053
Study Coordinator
856-261-6420
The Rivus Wellness & Research Institute ( Site 2014)Oklahoma CityOklahoma73112
Study Coordinator
405-607-2233
Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)PhiladelphiaPennsylvania19104
Study Coordinator
215-222-3200
Butler Hospital ( Site 1002)ProvidenceRhode Island02906
Study Coordinator
401-455-6440
Medical University of South Carolina ( Site 1005)CharlestonSouth Carolina29403
Study Coordinator
843-792-4636
Adams Clinical Dallas ( Site 2007)DeSotoTexas75115
Study Coordinator
972-283-6286
Memorial Hermann Village ( Site 2001)HoustonTexas77043
Study Coordinator
281-369-5765
VCU Institute for Drug and Alcohol Studies ( Site 1004)RichmondVirginia23219
Study Coordinator
804-827-3784

Find similar trials in New Haven, CT

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Yale University School of Medicine· New Haven, CTCenExel iResearch, LLC· Savannah, GAJohns Hopkins University· Baltimore, MDHassman Research Institute Marlton Site· Marlton, NJThe Rivus Wellness & Research Institute· Oklahoma City, OKPenn Medicine University of Pennsylvania Health System- Center for Studies of Addiction· Philadelphia, PA

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