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

Trial Summary

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.

How is the drug Suvorexant unique for treating opioid/stimulant co-use?

Suvorexant is unique because it is primarily used as a sleep aid, working by blocking orexin receptors in the brain, which is different from typical treatments for opioid or stimulant use that often target opioid receptors or dopamine pathways. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Jennifer Ellis, Ph.D.

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

MP1104, a mixed kappa-delta opioid receptor agonist has anti-cocaine properties with reduced side-effects in rats. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A phase 1b study to investigate the potential interactions between ASP8062 and buprenorphine/naloxone in patients with opioid use disorder. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of beta-funaltrexamine on butorphanol dependence. [2019]

4. Thailand pubmed.ncbi.nlm.nih.gov

Clinical study on fluvoxamine combined with oxycodone prolonged-release tablets in treating patients with moderate to severe cancer pain. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Human Abuse Potential of the New Opioid Analgesic Molecule NKTR-181 Compared with Oxycodone. [2019]