Suvorexant for Opioid Use Disorder
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?
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.12367
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.12456
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either suvorexant or placebo while maintained on medication-assisted treatments (MAT) for opioid use disorder
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebos (Behavioural Intervention)
- Suvorexant (Orexin Antagonist)
Suvorexant is already approved in United States, Australia, Japan for the following indications:
- Insomnia characterized by difficulties with sleep onset and/or sleep maintenance
- Insomnia characterized by difficulties with sleep onset and/or sleep maintenance
- Insomnia characterized by difficulties with sleep onset and/or sleep maintenance