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New treatment option for Suvorexant
Official title Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl
ClinicalTrials.gov ID: NCT05145764
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 suvorexant.
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
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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 65
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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) \>3x upper limit of normal (ULN)
- Total bilirubin \>2x ULN
- Creatinine \>1.5x ULN
- Past year clinically-significant psychiatric condition judged to interfere with study participation
- Lack of access to stable housing (necessary for electronic pill dispenser charging)
- Have circumstances that would interfere with study participation (e.g., impending jail)
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. 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.