Suvorexant for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Andrew S Huhn, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Johns Hopkins University

Must be taking: Methadone, Buprenorphine, XR-NTX

Must not be taking: Benzodiazepines, Suvorexant, Stimulants, others

Disqualifiers: Serious mental illness, Stimulant use, Pregnancy, others

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (MAT) who are in early recovery from opioid use disorder (OUD). Briefly, the study will enroll recently abstinent OUD patients (N=200) maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Within each MAT group, participants will be randomized to either suvorexant or placebo. The study is expected to have a 20% treatment attrition rate which will result in N=160 completers in the entire study. Patients will be recruited from and treated at Ashley Addiction Treatment, Addiction Treatment Services at Johns Hopkins Bayview Medical Center, Man Alive, or community providers.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to participate in this trial. Specifically, you cannot use benzodiazepines or other schedule IV medications for insomnia, Cytochrome P450 3A inhibitors, or glucocorticoid medications. If you are on these, you might need to stop them before joining the study.

What data supports the effectiveness of the drug Suvorexant for treating opioid use disorder?

Research suggests that Suvorexant, originally used for insomnia, may help reduce opioid cravings and withdrawal symptoms. In studies with rats and humans, it showed potential in decreasing drug-seeking behavior and improving sleep during opioid withdrawal. ^{1 2 3 4 5}

Is suvorexant safe for humans?

Suvorexant, also known as Belsomra, has been studied for its safety in humans, primarily for treating insomnia. It is generally considered safe at doses of 5-20 mg, though higher doses may cause next-morning drowsiness, unusual dreams, and other nighttime behaviors. Studies suggest it has a low potential for abuse and does not significantly interact with other drugs at clinical doses. ^{1 2 3 6 7}

How is the drug Suvorexant unique in treating opioid use disorder?

Suvorexant is unique because it is a dual orexin receptor antagonist originally approved for treating insomnia, and it works by blocking orexin receptors involved in wakefulness. This novel mechanism may help reduce drug-seeking behavior and relapse in opioid use disorder, offering a different approach compared to traditional treatments. ^{1 2 4 5 6}

Research Team

Andrew S Huhn, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults aged 21-65 with opioid use disorder who are in early recovery and experiencing sleep disturbances. They must be on medication-assisted treatments like methadone, buprenorphine, or XR-NTX, have abstained from illicit opioids for two weeks, and agree to weekly visits and daily monitoring. Exclusions include unstable serious mental illnesses, other severe substance disorders, certain medication allergies or uses, pregnancy/breastfeeding, specific sleep disorders like narcolepsy or severe apnea.

Inclusion Criteria

Have no clinically significant chronic medical disorders or conditions that are judged by the investigators to prevent participation.

Use of birth control throughout study

I am between 21 and 65 years old.

Exclusion Criteria

I am not taking steroids or medications that affect my hormone control system.

I have been diagnosed with narcolepsy, sleep paralysis, or restless leg syndrome.

You have shown signs of wanting to harm yourself in the past month, as evaluated by a specific questionnaire.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either suvorexant or placebo while maintained on medication-assisted treatments (MAT) for opioid use disorder

8 weeks

Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebos (Behavioural Intervention)
• Suvorexant (Orexin Antagonist)

Trial Overview The study tests whether suvorexant can improve sleep and reduce stress-related relapse behaviors in patients recovering from opioid addiction compared to a placebo. Participants maintained on different medications (methadone/buprenorphine/XR-NTX) will randomly receive either suvorexant or a placebo while their sleep patterns and stress levels are monitored.

Participant Groups

Group I: Suvorexant Active Control 1 Intervention

Sleep medication (20mg suvorexant; 2 10mg capsules; patients can self-titrate to 1 10mg capsule)

Group II: Placebo Placebo Group 1 Intervention

Placebo sleep medication (2 placebo oral capsules)

Suvorexant is already approved in United States, Australia, 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 Australia 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center Baltimore, MD

Man Alive Inc., Lane Treatment Center Baltimore, MD

Ashley Addiction Treatment Bel Air, MD

Ashley Addiction Treatment Elkton, MD

More Trial Locations

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2366

Patients Recruited

15,160,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3987

Patients Recruited

47,860,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical assessment of the abuse potential of the orexin receptor antagonist, suvorexant. Born, S., Gauvin, DV., Mukherjee, S., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue Distribution of Suvorexant in Three Forensic Autopsy Cases. Waters, B., Hara, K., Ikematsu, N., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant ameliorated sleep disturbance, opioid withdrawal, and craving during a buprenorphine taper. Huhn, AS., Finan, PH., Gamaldo, CE., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant, an FDA-approved dual orexin receptor antagonist, reduces oxycodone self-administration and conditioned reinstatement in male and female rats. Illenberger, JM., Flores-Ramirez, FJ., Matzeu, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Suvorexant in Urine Using Liquid Chromatography-Quadrupole/Time-of-Flight Mass Spectrometry (LC-Q/TOF-MS). Sullinger, S., Bryand, K., Kerrigan, S.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro and in vivo characterisation of the metabolism and disposition of suvorexant in humans. Cui, D., Cabalu, T., Yee, KL., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant for the treatment of insomnia. Jacobson, LH., Callander, GE., Hoyer, D.[2015]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Preclinical assessment of the abuse potential of the orexin receptor antagonist, suvorexant. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Tissue Distribution of Suvorexant in Three Forensic Autopsy Cases. [2018]

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

Suvorexant ameliorated sleep disturbance, opioid withdrawal, and craving during a buprenorphine taper. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Suvorexant, an FDA-approved dual orexin receptor antagonist, reduces oxycodone self-administration and conditioned reinstatement in male and female rats. [2023]

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

Identification of Suvorexant in Urine Using Liquid Chromatography-Quadrupole/Time-of-Flight Mass Spectrometry (LC-Q/TOF-MS). [2017]

6. England pubmed.ncbi.nlm.nih.gov

In vitro and in vivo characterisation of the metabolism and disposition of suvorexant in humans. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Suvorexant for the treatment of insomnia. [2015]