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Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl

Primary Purpose

Suvorexant, Placebo, Opioid Use Disorder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Suvorexant

Placebo

About this trial

This is an interventional treatment trial for Suvorexant focused on measuring Opioid use disorder, Insomnia, Suvorexant, Fentanyl, Buprenorphine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Johns Hopkins Bayview Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Suvorexant

Placebo

Arm Description

Nightly dosing of suvorexant

Nightly dosing of placebo

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05145764

First Posted

November 23, 2021

Last Updated

June 8, 2023

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT05145764

Brief Title

Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 30, 2022 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suvorexant, Placebo, Opioid Use Disorder

Keywords

Opioid use disorder, Insomnia, Suvorexant, Fentanyl, Buprenorphine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Suvorexant

Arm Type

Experimental

Arm Description

Nightly dosing of suvorexant

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Nightly dosing of placebo

Intervention Type

Drug

Intervention Name(s)

Suvorexant

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Total Sleep Time

Description

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 treatment

Title

Buprenorphine compliance as assessed by the number of study days complying with buprenorphine treatment

Description

Buprenorphine compliance will be assessed by the number of study days complying with buprenorphine treatment.

Time Frame

25 days across residential and outpatient treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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, 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrew S Huhn, Ph.D.

Phone

410-550-1971

ahuhn1@jhu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kelly E Dunn, Ph.D.

Phone

410-550-2254

kdunn9@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew S Huhn, Ph.D.

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Bayview Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrew S Huhn, Ph.D.

Phone

410-550-1971

ahuhn1@jhu.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl

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