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New treatment option for Insomnia
Official title A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
ClinicalTrials.gov ID: NCT06655883
What this study is testing
What is Suvorexant?
Suvorexant is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for insomnia.
Also referred to as MK-4305.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- The main 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...
- 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.
You likely can't join if
- 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...
- Has current diagnosis or history within 5 years of any of the following: narcolepsy, sleep paralysis, severe periodic limb movement disorder...
- 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.
See the full eligibility criteria
- The main 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Savannah, Georgia, United States
- Baltimore, Maryland, United States
- Marlton, New Jersey, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Charleston, South Carolina, United States
- DeSoto, Texas, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Savannah, Georgia, United States; Baltimore, Maryland, United States; Marlton, New Jersey, United States; Oklahoma City, Oklahoma, United States; Philadelphia, Pennsylvania, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.