Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Suvorexant, Placebo.
- Who it may be relevant to
- Registry conditions: Suvorexant, Placebo, Opioid Use Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Suvorexant as an Adjunct to Buprenorphine Induction and Maintenance in Persons Who Use Fentanyl
Overview
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).
Detailed description
This study will enroll persons with opioid use disorder (N=120) who have recent fentanyl exposure (as assessed via urinalysis testing). Participants will be randomized to receive suvorexant or placebo for the duration of the study enrollment, which will serve as the between-groups experimental comparison. The study will consist of a brief (5 day) residential phase and 3-week outpatient phase. During the residential phase, all participants will be briefly maintained on a short acting opioid prior to induction onto sublingual (SL) buprenorphine (using either the buprenorphine or buprenorphine/naloxone product). At the end of the 5-day residential period, participants will be discharged to complete the \~3-week outpatient phase. During the outpatient period all participants will be maintained on SL buprenorphine/naloxone and continue to receive suvorexant or placebo, and at the end of the study participants will receive an injection of XR-buprenorphine (Sublocade). All buprenorphine procedures will be open label and will follow standard-of-care practices. Study medication during the outpatient period will be managed using an automated pill dispenser. Data collection will consist of forehead-based EEG monitoring, wrist-worn actigraphy/photoplethysmography, and questionnaires delivered during study visits or via cell-phone based ecological momentary assessments.
Interventions
- Drug Suvorexant
Encapsulated suvorexant (matched for color, weight, and size) - Drug Placebo
Encapsulated placebo (matched for color, weight, and size)
Primary outcome measures
- Total Sleep Time [Time frame: 3 nights during the initial residential phase and 1 night at the end of outpatient treatment]
- Buprenorphine compliance as assessed by the number of study days complying with buprenorphine treatment [Time frame: 25 days across residential and outpatient treatment]
Eligibility criteria
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) \>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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Johns Hopkins Bayview Medical Center — Baltimore
Identifiers
NCT: NCT05145764 · IRB00301337 · UH3DA048734