Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJohns Hopkins University
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Suvorexant
- Placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov