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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Suvorexant
DrugEncapsulated suvorexant (matched for color, weight, and size)
Placebo
DrugEncapsulated placebo (matched for color, weight, and size)
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: SuvorexantExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total Sleep Time
Duration of nightly total sleep time in minutes, as measured by electroencephalography (EEG) and supplemented by actigraphy/photoplethysmography (e.g., if EEG malfunctions).
Time frame
3 nights during the initial residential phase and 1 night at the end of outpatient treatment2
Buprenorphine compliance as assessed by the number of study days complying with buprenorphine treatment
Buprenorphine compliance will be assessed by the number of study days complying with buprenorphine treatment.
Time frame
25 days across residential and outpatient treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov