Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05145764

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

120

Enrollment

Location

Arms

36.1

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Suvorexant Placebo Opioid Use Disorder	Drug: Suvorexant Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Suvorexant as an Adjunct to Buprenorphine Induction and Maintenance in Persons Who Use Fentanyl

Actual Study Start Date :

Mar 30, 2022

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Suvorexant Nightly dosing of suvorexant	Drug: Suvorexant Encapsulated suvorexant (matched for color, weight, and size)
Placebo Comparator: Placebo Nightly dosing of placebo	Drug: Placebo Encapsulated placebo (matched for color, weight, and size)

Arm

Intervention/Treatment

Experimental: Suvorexant

Nightly dosing of suvorexant

Drug: Suvorexant

Encapsulated suvorexant (matched for color, weight, and size)

Placebo Comparator: Placebo

Nightly dosing of placebo

Drug: Placebo

Encapsulated placebo (matched for color, weight, and size)

Outcome Measures

Primary Outcome Measures

Total Sleep Time [3 nights during the initial residential phase and 1 night at the end of outpatient treatment]
Duration of nightly total sleep time in minutes, as measured by electroencephalography (EEG) and supplemented by actigraphy/photoplethysmography (e.g., if EEG malfunctions).
Buprenorphine compliance as assessed by the number of study days complying with buprenorphine treatment [25 days across residential and outpatient treatment]
Buprenorphine compliance will be assessed by the number of study days complying with buprenorphine treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, benzodiazepine, or stimulant 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)