Suvorexant for Opioid Use Disorder
Trial Summary
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.
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.
12345Suvorexant, 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.
12367Suvorexant 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.
12456Eligibility 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
Participant Groups
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