What side effects are associated with this type of intervention?

Common treatments for Opioid Use Disorder include buprenorphine, naltrexone, and methadone. Buprenorphine can cause side effects such as constipation, headache, nausea, and sweating. Naltrexone may lead to nausea, headache, dizziness, and fatigue. Methadone's side effects include drowsiness, dry mouth, and respiratory depression. Suvorexant, an Orexin Receptor Antagonist being studied for its potential in treating OUD, has side effects like daytime sleepiness, dizziness, and abnormal dreams. These side effects should be discussed with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder, including methadone, buprenorphine, and naltrexone. These medications work through different mechanisms: methadone is a full opioid agonist, buprenorphine is a partial opioid agonist, and naltrexone is an opioid antagonist. Suvorexant, an orexin receptor antagonist, is being studied for its potential to reduce drug use, craving, and improve sleep and stress in individuals with OUD. While Suvorexant's mechanism differs from traditional OUD treatments, it represents a novel approach by targeting the orexin system, which is involved in regulating wakefulness and stress responses.

What other types of research exist?

Promising novel alternatives to Suvorexant for Opioid Use Disorder patients in 2024 include medications like buprenorphine, which is effective for opioid dependence and has various formulations (sublingual, buccal, transdermal). Additionally, emerging treatments such as extended-release naltrexone and combination therapies involving naltrexone and bupropion are showing potential. These alternatives not only address opioid dependence but also help manage co-occurring conditions and improve overall treatment outcomes.

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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

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

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 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: SuvorexantActive Control1 Intervention

20mg Suvorexant

Group II: PlaceboPlacebo Group1 Intervention

Placebo oral capsules

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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.