Suvorexant for Opioid/Stimulant Co-use

NCT05546515 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00341328
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stimulant Use Disorder; Opioid Use Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Opioid Use: Proportion of Positive Urine Drug Screens (UDS)

  Opioid use (measured via uranalysis for qualitative opioid assay) other than prescribed methadone or buprenorphine at scheduled study visits up to 30 days post-randomization (yes vs. no)

  Up to 30 days post-randomization

• Cocaine Use: Proportion of Positive UDS Screens

  Cocaine use (measured via uranalysis for qualitative cocaine assay) at scheduled study visits up to 30 days post-randomization.

  Up to 30 days post-randomization

Secondary Outcomes (5)

• Insomnia Severity Regression Slope

  Up to 30 days post-randomization

• Total Sleep Time (TST) Regression Slope

  Up to 30 days post-randomization

• Opioid Craving Visual Analog Scale (VAS) Regression Slope

  Up to 30 days post-randomization

• Cocaine Craving Visual Analog Scale (VAS) Regression Slope

  Up to 30 days post-randomization

• Perceived Stress Scale Regression Slope

  Up to 30 days post-randomization

Study Arms (2)

Suvorexant

ACTIVE COMPARATOR

20mg Suvorexant

Drug: Suvorexant (dual orexin receptor antagonist)

Placebo

PLACEBO COMPARATOR

Placebo oral capsules

Drug: Placebo

Interventions

Suvorexant (dual orexin receptor antagonist) DRUG

Participants will be prescribed up to 30 days of SUVO.

Suvorexant

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Chemically-Induced Disorders

Interventions

suvorexant; Orexin Receptor Antagonists

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Sleep Aids, Pharmaceutical; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Jennifer Ellis
• Organization: Johns Hopkins School if Medicine

jellis36@jhmi.edu

4105506346

Study Officials

• Jennifer Ellis, Ph.D.

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research pharmacy will manage all randomization and blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: December 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)