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Dual Orexin Receptor Antagonist

Suvorexant for Opioid/Stimulant Co-use

Phase 2
Recruiting
Led By Kelly E Dunn, Ph.D, M.B.A.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post-randomization
Awards & highlights

Study Summary

This trial will see if a drug called Suvorexant can help people with addiction to both opioids and stimulants by reducing cravings and improving sleep and stress.

Who is the study for?
This trial is for adults aged 18-65 with both opioid and stimulant use disorders who are stable on methadone or buprenorphine. Participants must not have severe psychiatric conditions, be pregnant/breastfeeding, use certain sedatives, have other substance abuse issues, taken SUVO recently, shown suicidal behavior or require a CPAP device.Check my eligibility
What is being tested?
The study tests if Suvorexant (20mg), which blocks certain brain receptors to affect sleep and stress responses, can reduce drug use and cravings in people with co-occurring opioid and stimulant disorders compared to a placebo.See study design
What are the potential side effects?
Suvorexant may cause drowsiness, headaches, dizziness, dry mouth or even more serious side effects like sleep-walking or other complex behaviors during sleep.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cocaine use
Opioid use
Secondary outcome measures
Sleeplessness
Perceived Stress Scale Total Score
Total sleep time
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: SuvorexantActive Control1 Intervention
20mg Suvorexant
Group II: PlaceboPlacebo Group1 Intervention
Placebo oral capsules

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,273 Previous Clinical Trials
14,840,352 Total Patients Enrolled
Kelly E Dunn, Ph.D, M.B.A.Principal InvestigatorJohns Hopkins School of Medicine
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Suvorexant (Dual Orexin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05546515 — Phase 2
Opioid Use Disorder Research Study Groups: Suvorexant, Placebo
Opioid Use Disorder Clinical Trial 2023: Suvorexant Highlights & Side Effects. Trial Name: NCT05546515 — Phase 2
Suvorexant (Dual Orexin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05546515 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For whom would this clinical trial be most advantageous?

"This clinical trial is seeking 40 individuals within the age range of 18-65 who suffer from opioid use disorder (OUD). In order to qualify, participants must meet certain criteria as outlined in the DSM-5-TR, receive methadone or buprenorphine medication for OUD and have been stable on their dose for at least 30 days. Furthermore, they need to be willing to comply with study regulations and practice birth control if necessary."

Answered by AI

What outcomes does this investigation hope to attain?

"The principal outcome of the experiment, tracked for up to a month following randomized treatment, is Cocaine use. Secondary objectives include Total sleep time in minutes at study visits within 30 days post-randomization; Insomnia Severity Index total score from assessments conducted over the same period; and Visual Analog Rating (0-100) of Opioid Craving as ascertained through VAS surveys during this timeframe."

Answered by AI

Has Suvorexant obtained authorization from the FDA?

"Our team at Power has rated the safety of Suvorexant as a 2, due to its status as an experimental drug in Phase 2 trials. This implies that there is some data surrounding its protective properties but no clinical studies have yet confirmed efficacy."

Answered by AI

Is this trial still enrolling participants?

"According to information gathered from clinicaltrials.gov, it appears that this particular trial has stopped actively recruiting patients - the last edit was made on September 14th 2022. Nonetheless, 1147 other studies are currently enrolling participants at present."

Answered by AI

Are seniors encouraged to participate in the clinical trial?

"This clinical trial is open to all individuals who are over the age of consent and below 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Michigan
What site did they apply to?
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Suvorexant for Opioid/Stimulant Co-use
2022. "Suvorexant for Opioid/Stimulant Co-use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05546515.
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~10 spots leftby Nov 2024
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