Suvorexant for Opioid/Stimulant Co-use

Overseen By Jennifer Ellis, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must be taking: Methadone, Buprenorphine

Must not be taking: Benzodiazepines, Tranquilizers

Disqualifiers: Pregnant, Suicidal behavior, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Suvorexant (also known as Belsomra) can aid individuals using both opioids and stimulants by reducing drug use and cravings, and improving sleep and stress levels. Participants will receive either Suvorexant or a placebo (a pill with no active ingredients). The trial seeks individuals diagnosed with a stimulant use disorder who are currently stable on methadone or buprenorphine treatment for opioid use disorder. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you stop using benzodiazepines, tranquilizers, or other schedule IV sleep medications. Also, you cannot use medications that are contraindicated (not safe to use) with the study.

Is there any evidence suggesting that Suvorexant is likely to be safe for humans?

Research has shown that Suvorexant is generally safe and well-tolerated. In studies involving individuals with sleep difficulties, Suvorexant demonstrated a strong safety record, with most participants not experiencing serious side effects. Common side effects, such as sleepiness or dizziness, are usually mild.

One study examined Suvorexant's effects on individuals with opioid use disorder to assess its potential to improve sleep. This study also found Suvorexant to be safe for participants.

While Suvorexant is approved for treating insomnia, its use in individuals with opioid and stimulant use disorders remains under investigation. Researchers are evaluating its effectiveness and safety for this new purpose. Current evidence suggests it is safe to try. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care options for opioid and stimulant co-use, which typically involve therapies like methadone or buprenorphine for opioids and behavioral therapies for stimulants, Suvorexant offers a unique approach by targeting the orexin system in the brain. Most treatments focus on managing withdrawal symptoms or blocking the effects of the drugs. However, Suvorexant, originally designed for insomnia, works differently by potentially reducing cravings and improving sleep through its action as an orexin receptor antagonist. Researchers are excited about Suvorexant because it could offer a dual benefit: addressing sleep disturbances common in substance use disorders while also potentially reducing the urge to use these substances.

What evidence suggests that Suvorexant might be an effective treatment for opioid and stimulant co-use?

Research has shown that suvorexant, which participants in this trial may receive, may help individuals with opioid and stimulant use disorders by improving sleep and reducing cravings. Studies have found that suvorexant can address sleep problems related to cocaine withdrawal and lessen the urge to use cocaine. Early results suggest that suvorexant can increase sleep time during opioid withdrawal without causing addiction. Additionally, early research indicates it may effectively reduce drug cravings. This evidence supports the potential of suvorexant to assist with sleep issues and cravings in individuals dealing with these substance use disorders. ^{1 2 6 7 8}

Who Is on the Research Team?

Jennifer Ellis, Ph.D.

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Use of birth control (as appropriate)

Willingness to engage with study protocol

Meet criteria for stimulant use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR)

Exclusion Criteria

Psychiatric or medical conditions that are judged by the investigators to interfere with participation or that are contraindicated for use with SUVO

Past 30-day suicidal behavior

Use of continuous positive airway pressure (CPAP) device for sleep apnea

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 30 days of Suvorexant or placebo while attending regular clinic visits for assessments

4 weeks

Regular clinic visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Suvorexant

Trial Overview 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.

How Is the Trial Designed?

Group I: Suvorexant Active Control 1 Intervention

20mg Suvorexant

Group II: Placebo Placebo Group 1 Intervention

Placebo oral capsules

Suvorexant is already approved in United States, Japan for the following indications:

Approved in United States as Belsomra for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Approved in Japan as Belsomra for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06655883

NCT06655883 | A Study of Suvorexant (MK-4305) for the ... Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep. The goal of this study is to learn about the safety of suvorexant ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05546515

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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871623001977

Preclinical Evidence Supporting the Repurposing of ... Suvorexant normalizes sleep disturbances associated with initial cocaine abstinence and facilitates the extinction of cocaine seeking behaviors.

4. reporter.nih.gov reporter.nih.gov/project-details/10454583

Evaluating Suvorexant for Sleep Disturbance in Opioid Use ... We hypothesize SUVO will improve total sleep time during withdrawal, will not show evidence of abuse liability, and will be more efficacious than trazodone.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7265392/

Repurposing the dual orexin receptor antagonist suvorexant ... Fortunately, recent preclinical results indicate that low doses may be effective for reducing drug craving, as Ox1R antagonists are more effective at lower ...

6. withpower.com withpower.com/trial/phase-2-opioid-related-disorders-11-2022-727af

Suvorexant for Opioid/Stimulant Co-use · Info for Participants 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12552597/

Found in translation: orexin receptor antagonism for the ... Additionally, suvorexant treatment exhibited promising effects ... Reducing co-occurring opioid and stimulant use (Includes outpatient component) ...

8. science.org science.org/doi/10.1126/scitranslmed.abn8238

Suvorexant ameliorated sleep disturbance, opioid ... Suvorexant is also known to have an excellent safety profile in persons with insomnia (15, 24), and the results of this trial provide evidence ...