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Suvorexant for Opioid/Stimulant Co-use

NCT ID: NCT05546515

Last Updated: 2025-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-11-30

Brief Summary

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This study will evaluate whether Suvorexant 20mg reduces drug use and craving, and improves sleep and stress among persons with co-occurring opioid use disorder and stimulant use disorder.

Detailed Description

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This between-subjects, double-blinded, randomized controlled pilot study will recruit patients who are receiving methadone or buprenorphine treatment for OUD and are using cocaine. Participants will be randomly assigned to receive up to 30-days of Suvorexant (SUVO) or placebo. They will visit the clinic regularly to provide urine drug screens and complete questionnaires and will wear a device that can measure their sleep parameters. We expect that relative to persons who receive placebo, individuals who receive SUVO will 1) be less likely to screen positive for cocaine and/or opioids on urine drug screens, 2) will report lower drug craving, 3) will have longer total sleep time, 4) will report fewer insomnia symptoms, and 5) will report overall lower stress than persons who receive placebo. We also expect that patients will not have side effects from SUVO. These preliminary data will inform whether this FDA-approved medication may help patients stop co-using opioids and stimulants, which can be scaled up to reduce public health consequences related to co-use.

Conditions

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Opioid Use Disorder Stimulant Use Disorder

Keywords

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Orexin receptor antagonist Suvorexant Cocaine Opioid Opiate Heroin Fentanyl Nonmedical opioid use Methadone Buprenorphine Suboxone Polysubstance use Co-use Substance-related disorders Narcotic-related disorders Chemically-induced disorders Sleep Stress Opioid-related disorders Stimulant-related disorders Cocaine use disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The research pharmacy will manage all randomization and blinding.

Study Groups

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Suvorexant

20mg Suvorexant

Group Type ACTIVE_COMPARATOR

Suvorexant (dual orexin receptor antagonist)

Intervention Type DRUG

Participants will be prescribed up to 30 days of SUVO.

Placebo

Placebo oral capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will be prescribed up to 30 days of placebo medication.

Interventions

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Suvorexant (dual orexin receptor antagonist)

Participants will be prescribed up to 30 days of SUVO.

Intervention Type DRUG

Placebo

Participants will be prescribed up to 30 days of placebo medication.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Ages 18-65,
2. Meet criteria for stimulant use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR)
3. Currently receiving methadone or buprenorphine treatment for OUD and considered to be stable on current dose for at least 30 days
4. Willingness to engage with study protocol
5. Use of birth control (as appropriate)

Exclusion Criteria

1. Psychiatric or medical conditions that are judged by the investigators to interfere with participation or that are contraindicated for use with SUVO
2. Pregnant or breastfeeding
3. Current use of benzodiazepines, tranquilizers, or other schedule IV sleep medications
4. Moderate or severe substance use disorder other than opioid or stimulant use disorder
5. SUVO consumption in the last 30 days
6. Use of medications that are contraindicated with the study
7. Past 30-day suicidal behavior
8. Use of continuous positive airway pressure (CPAP) device for sleep apnea
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Ellis, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

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Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB00341328

Identifier Type: -

Identifier Source: org_study_id