Opioid Use DisorderPhase 2NCT05546515
Suvorexant for Opioid/Stimulant Co-use
A Phase 2 study testing Suvorexant (dual orexin receptor antagonist) in people with Opioid Use Disorder and Stimulant Use Disorder, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder, Stimulant Use Disorder
- What is being tested?
- Suvorexant (dual orexin receptor antagonist)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 30 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Safety and Efficacy of Suvorexant for Opioid/Stimulant Co-use Among Individuals in Treatment for Opioid Use Disorder (OUD)
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.
Read the detailed description
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
- Opioid Use Disorder, Stimulant Use Disorder
- Being tested
- Suvorexant (dual orexin receptor antagonist), Placebo
- 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
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Narcotic-Related Disorders, Chemically-Induced Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suvorexant (dual orexin receptor antagonist)Drug
Participants will be prescribed up to 30 days of SUVO.
PlaceboDrug
Participants will be prescribed up to 30 days of placebo medication.
| Study group | Role | What they receive |
|---|---|---|
| Suvorexant | Active comparator | 20mg Suvorexant Receives: Drug: Suvorexant (dual orexin receptor antagonist) |
| Placebo | Placebo comparator | Placebo oral capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Up to 30 days post-randomization
Secondary outcomes (5)
Insomnia Severity Regression Slope
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.
Measured: Up to 30 days post-randomization
Total Sleep Time (TST) Regression Slope
Regression slope of TST scores over scheduled study visits up to 30 days post-randomization.
Measured: Up to 30 days post-randomization
Opioid Craving Visual Analog Scale (VAS) Regression Slope
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.
Measured: Up to 30 days post-randomization
Cocaine Craving Visual Analog Scale (VAS) Regression Slope
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.
Measured: Up to 30 days post-randomization
Perceived Stress Scale Regression Slope
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.
Measured: Up to 30 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Dec 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Ellis, Ph.D., Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546515
- Sponsor's protocol ID
- IRB00341328
- Status last verified
- Dec 2025
- First submitted
- 14 Sep 2022
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Suvorexant for Opioid/Stimulant Co-use Among Individuals in Treatment for Opioid Use Disorder (OUD)
- ClinicalTrials.gov ID
- NCT05546515
- Acronym / sponsor ID
- IRB00341328
- Conditions
- Opioid Use Disorder, Stimulant Use Disorder
- Keywords
- Orexin receptor antagonist, Suvorexant, Cocaine, Opioid, Opiate, Heroin, Fentanyl, Nonmedical opioid use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suvorexant | Active comparator | Drug: Suvorexant (dual orexin receptor antagonist)20mg Suvorexant |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suvorexant (dual orexin receptor antagonist)Participants will be prescribed up to 30 days of SUVO. | Drug | Suvorexant |
| PlaceboParticipants will be prescribed up to 30 days of placebo medication. | Drug | Placebo |
Primary outcome
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)
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.
5 secondary outcomes
Insomnia Severity Regression Slope
Time frame: Up to 30 days post-randomization
Total Sleep Time (TST) Regression Slope
Time frame: Up to 30 days post-randomization
Opioid Craving Visual Analog Scale (VAS) Regression Slope
Time frame: Up to 30 days post-randomization
Cocaine Craving Visual Analog Scale (VAS) Regression Slope
Time frame: Up to 30 days post-randomization
Perceived Stress Scale Regression Slope
Time frame: Up to 30 days post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Ellis, Ph.D. principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suvorexant (dual orexin receptor antagonist) in people with Opioid Use Disorder and Stimulant Use Disorder, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Use: Proportion of Positive Urine Drug Screens (UDS) (time frame: Up to 30 days post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.