Understanding how the orexin system affects sleep and stress in people recovering from opioid use disorder
Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder
This study is testing if a new sleep medication can help people recovering from opioid use disorder manage their sleep and stress better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 5 sites (Baltimore, Maryland and 4 other locations) |
| Trial ID | NCT04287062 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of the orexin neurotransmitter system in sleep disturbances and stress-related behaviors that may influence relapse in individuals undergoing medication-assisted treatment for opioid use disorder. It will enroll 200 recently abstinent patients on either naltrexone, buprenorphine, or methadone, who will be randomized to receive either the orexin receptor antagonist suvorexant or a placebo. Participants will undergo weekly visits and assessments to monitor their sleep and stress levels throughout the study. The goal is to better understand how targeting the orexin system could improve recovery outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-65 with a recent history of sleep disturbances and currently enrolled in medication-assisted treatment for opioid use disorder.
Not a fit: Patients with serious unstable mental illnesses or significant chronic medical disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for sleep disturbances in patients recovering from opioid use disorder, potentially reducing relapse rates.
How similar studies have performed: While the specific approach of targeting the orexin system in this context is novel, related studies have shown promise in addressing sleep disturbances in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between the ages of 21-65, inclusive. * Past 30-day sleep disturbance as evidenced by a Pittsburgh Sleep Quality Index Total Score \>5. * Enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, or XR-NTX treatment for OUD. * Willingness to be maintained on a protocolized dose starting between 60-130mg methadone or 380mg XR-NTX for the duration of the study. * At least two weeks of continuous abstinence from illicit opioids as evidenced by self-report and urine drug screens collected as part of routine care. * Willing to comply with the study protocol, which will include weekly study visits, daily actigraphy and ecological momentary assessments. * Use of birth control throughout study. * Have no clinically significant chronic medical disorders or conditions that are judged by the investigators to prevent participation. Exclusion Criteria: * Serious mental illnesses that are unstable and could affect study participation (thought disorders, hallucinations, delusions, thoughts of harm to self/others). * Current moderate to severe substance use disorder other than OUD. * Current illicit stimulant use, including cocaine and methamphetamine. * Pregnant or breast feeding. * Have a known allergy to the study medications. * Past 30-day prescribed use of suvorexant. * Current use of a benzodiazepine or other schedule IV medication for insomnia. * Use of Cytochrome P450 3A inhibitors. * Current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medical history * Apnea-hypopnea index \> 30. * Use of glucocorticoid medications and any medication that would alter the hypothalamic-pituitary-adrenal axis. * Past 30-day suicidal behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). * Have circumstances that would interfere with study participation (e.g., impending jail; severe clinical issues).
Where this trial is running
Baltimore, Maryland and 4 other locations
- Man Alive Inc., Lane Treatment Center — Baltimore, Maryland, United States (Recruiting)
- Addiction Treatment Services at Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
- Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
- Ashley Addiction Treatment — Bel Air, Maryland, United States (Recruiting)
- Ashley Addiction Treatment — Elkton, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Andrew S Huhn, PhD — Johns Hopkins University
- Study coordinator: Andrew S Huhn, PhD
- Email: ahuhn1@jhu.edu
- Phone: 410-550-1971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.