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Dual Orexin Receptor Antagonist
Suvorexant for Opioid/Stimulant Co-use
Phase 2
Recruiting
Led By Jennifer Ellis, Ph.D.
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
Summary
This trial will test if Suvorexant can help people with opioid and stimulant use disorders reduce drug use, cravings, and stress while improving their sleep. Participants will receive Suvorexant for a period of time. The study aims to see if those taking Suvorexant have better outcomes. Suvorexant has been shown to improve sleep onset and maintenance in patients with insomnia.
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post-randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cocaine use
Opioid use
Secondary study objectives
Sleeplessness
Perceived Stress Scale Total Score
Total sleep time
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: SuvorexantActive Control1 Intervention
20mg Suvorexant
Group II: PlaceboPlacebo Group1 Intervention
Placebo oral capsules
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Opioid Use Disorder (OUD) include methadone, buprenorphine, and naltrexone. Methadone is a full opioid agonist that reduces withdrawal symptoms and cravings by activating opioid receptors in the brain, providing a controlled and safer alternative to illicit opioid use.
Buprenorphine is a partial opioid agonist that also activates opioid receptors but to a lesser extent, which helps in reducing cravings and withdrawal symptoms with a lower risk of misuse. Naltrexone is an opioid antagonist that blocks opioid receptors, preventing the euphoric effects of opioids and thus discouraging relapse.
These treatments are crucial as they help stabilize patients, reduce illicit opioid use, and improve overall functioning. Orexin receptor antagonists like Suvorexant, although primarily used for insomnia, are being studied for their potential to reduce drug use and cravings in patients with co-occurring opioid and stimulant use disorders, highlighting the ongoing search for effective treatments in this patient population.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,332 Previous Clinical Trials
14,874,860 Total Patients Enrolled
Jennifer Ellis, Ph.D.Principal InvestigatorJohns Hopkins School of Medicine
Kelly E Dunn, Ph.D, M.B.A.Principal InvestigatorJohns Hopkins School of Medicine
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking benzodiazepines, tranquilizers, or similar sleep medications.I am between 18 and 65 years old.I am not taking any medications that the study does not allow.I have been on a stable dose of methadone or buprenorphine for OUD for at least 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Suvorexant
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.