Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl (NCT05145764) | Clinical Trial Compass
CompletedPhase 2
Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl
United States76 participantsStarted 2022-03-30
Plain-language summary
This is a 4-week, randomized-controlled trial of suvorexant vs placebo in persons with opioid use disorder who have recent fentanyl exposure. Participants will first undergo a 5-day residential phase wherein participants are stabilized on sublingual buprenorphine/naloxone, followed by a 3-week outpatient phase wherein participants are maintained on sublingual buprenorphine/naloxone and transitioned to extended-release buprenorphine).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18-65
* Meets DSM-5 criteria for opioid use disorder (OUD) with evidence of physical dependence on opioids
* Provides a urine sample that tests positive for fentanyl and/or fentanyl analogues
* Interest in being maintained on buprenorphine for OUD
* Plans to reside in current area for study period
* Achieving a study maintenance dose of \>=8mg sublingual buprenorphine/naloxone
* Willing to comply with study protocol
* Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation
Exclusion Criteria:
* Medically contraindicated for buprenorphine, extended-release (XR)-buprenorphine (Sublocade), or suvorexant (as per medication labels)
* Pregnant or breast feeding
* Severe Diagnostic and Statistical Manual (DSM)-5 alcohol or benzodiazepine use disorder or evidence of alcohol/benzodiazepine physical dependence
* Have a known allergy to the study medications
* Past 30-day prescribed use of suvorexant for the indication of insomnia
* Current benzodiazepine or other prescribed medication for the indication of insomnia
* Urine sample testing positive for benzodiazepine at screening and admission to residential treatment
* Current narcolepsy, restless leg syndrome or sleep paralysis
* High risk for current sleep apnea
* Current (past 30-day) suicidal behaviors
* Severe hepatic or renal impairment
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \&g…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Sleep Time
Timeframe: 3 nights during the initial residential phase and 1 night at the end of outpatient treatment
2
Buprenorphine compliance as assessed by the number of study days complying with buprenorphine treatment
Timeframe: 25 days across residential and outpatient treatment