Using suvorexant with buprenorphine for opioid use disorder in fentanyl users
Suvorexant as an Adjunct to Buprenorphine Induction and Maintenance in Persons Who Use Fentanyl
This study is testing if adding a sleep medication called suvorexant to buprenorphine can help people with opioid use disorder who have used fentanyl feel better and improve their treatment results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05145764 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of suvorexant as an adjunct treatment to buprenorphine in individuals with opioid use disorder who have recently used fentanyl. The study involves a 4-week randomized-controlled design, starting with a 5-day residential phase for stabilization on buprenorphine, followed by a 3-week outpatient phase. Participants will be monitored using EEG and actigraphy to assess sleep patterns and overall health during the treatment period. The trial aims to determine if suvorexant can improve treatment outcomes for this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of opioid use disorder and recent fentanyl exposure.
Not a fit: Patients who are pregnant, breastfeeding, or have severe alcohol or benzodiazepine use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could enhance recovery outcomes for patients with opioid use disorder, particularly those affected by fentanyl use.
How similar studies have performed: While the combination of suvorexant and buprenorphine is a novel approach, previous studies have shown promise in treating opioid use disorder with buprenorphine alone.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Andrew S Huhn, Ph.D. — Johns Hopkins University
- Study coordinator: Andrew S Huhn, Ph.D.
- Email: ahuhn1@jhu.edu
- Phone: 410-550-1971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.