Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl

Launched by JOHNS HOPKINS UNIVERSITY · Nov 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called suvorexant when combined with buprenorphine in people who have recently used fentanyl and are dealing with opioid use disorder (OUD). The trial lasts for four weeks and includes a residential phase where participants will stabilize on buprenorphine/naloxone for five days, followed by three weeks of outpatient care. Participants will be randomly assigned to receive either suvorexant or a placebo (a pill with no active medication) to see how well it helps with their treatment.

To be eligible for this trial, participants must be between 18 and 65 years old, have a confirmed diagnosis of opioid use disorder, and must have recently tested positive for fentanyl. They should also be interested in continuing treatment with buprenorphine. However, individuals with certain medical conditions, such as severe liver or kidney problems, or those who are pregnant or breastfeeding, cannot participate. Throughout the trial, participants can expect close monitoring and support as they work towards recovery.

Gender

ALL

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)