Skip to main content
OpenTrials
Completed

NCT Number: NCT05546515

Suvorexant for Opioid/Stimulant Co-use

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Suvorexant (dual orexin receptor antagonist)

Drug

Participants will be prescribed up to 30 days of SUVO.

Placebo

Drug

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

Primary outcomes

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

    Time frame: Up to 30 days post-randomization

    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)

  2. Cocaine Use: Proportion of Positive UDS Screens

    Time frame: Up to 30 days post-randomization

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

Secondary outcomes

  1. Insomnia Severity Regression Slope

    Time frame: Up to 30 days post-randomization

    Regression slope of Insomnia Severity Index (ISI) scores over scheduled study visits through 30 days post-randomization. Total score range between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). Higher score worse insomnia.

  2. Total Sleep Time (TST) Regression Slope

    Time frame: Up to 30 days post-randomization

    Regression slope of TST scores over scheduled study visits up to 30 days post-randomization.

  3. Opioid Craving Visual Analog Scale (VAS) Regression Slope

    Time frame: Up to 30 days post-randomization

    Regression slope of opioid craving VAS scores over scheduled study visits through 30 days post-randomization. Score range 0-10 with higher score indicating worse craving.

  4. Cocaine Craving Visual Analog Scale (VAS) Regression Slope

    Time frame: Up to 30 days post-randomization

    Regression slope of cocaine craving VAS scores over scheduled study visits through 30 days post-randomization. Score range 0-10 with higher score indicating worse craving.

  5. Perceived Stress Scale Regression Slope

    Time frame: Up to 30 days post-randomization

    Regression slope of Perceived Stress Scale (PSS) scores over scheduled study visits through 30 days post-randomization. Total score range 0 to 40, with higher scores indicating worse perceived stress.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Safety and Efficacy of Suvorexant for Opioid/Stimulant Co-use Among Individuals in Treatment for Opioid Use Disorder (OUD)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2022
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.