Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called lemborexant can help improve sleep and mood in people with Opioid Use Disorder who are already receiving treatment with buprenorphine. The researchers want to find out if lemborexant can make a difference in how well participants sleep, how they behave impulsively, and how they feel emotionally. To do this, some participants will receive lemborexant, while others will receive a placebo, which is like a sugar pill with no active medication. The trial will last for 8 weeks and will involve 23 visits to the study site, where participants will answer questions about their sleep and mood, take urine tests, and wear a watch to track their sleep at home.

To be eligible for the trial, participants need to be at least 18 years old, have a diagnosed opioid use disorder, and have been stable on a prescribed buprenorphine dosage for at least 4 weeks. They should also experience chronic insomnia and meet certain health criteria. Participants will need to provide informed consent and have access to a computer or smartphone for virtual surveys. It’s important to note that individuals with certain sleep disorders, mental health conditions, or who are currently taking specific medications may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Be 18 + years-of-age
• • 2. Meet current DSM-5 criteria for opioid use disorder (OUD) with at least moderate severity
• • 3. Receiving outpatient treatment for OUD with sublingual buprenorphine film/tablets ranging 8mg to 24mg or with extended-release injectable buprenorphine
• • 4. Stabilized on current buprenorphine dosage for at least 4 weeks without intention for dose change within next 3 months.
• • 5. Screening urine toxicology positive for buprenorphine and an appropriate norbuprenorphine level as determined by a study clinician
• • 6. A screening urine toxicology negative for non-prescribed substances (except cannabinoids) with a negative breath (or oral fluid) alcohol screen
• • 7. Screen positive for chronic insomnia on the Insomnia Symptom Questionnaire (ISQ)
• • 8. Have an Insomnia Severity Index score at screening and baseline of 13 or higher
• • 9. Have no clinically significant medical or psychiatric disorder or condition, based on physical exam and medical history performed by study clinician, that in the judgement of the investigator would prevent participation or heighten safety risks
• • 10. Understand the study procedures and provide written informed consent in English language
• • 11. Access to necessary resources for completing virtual surveys and monitoring (i.e., computer or smartphone, internet or cell service)
• Exclusion Criteria:
• • 1. Current diagnosis of sleep-related breathing disorder, narcolepsy, somnambulism, or sleep paralysis
• • 2. A positive screen for sleep apnea by the following: Sleep Disorders Screening Battery (STOP-BAG \>5) OR home sleep apnea test using WatchPAT with Apnea Hypopnea Index (AHI) with 3% drop in oxygen saturation \> 10 OR \>50% of respiratory events being central if AHI is between 5-10 OR Oxygen Desaturation \< 88% for \> 10 minutes, OR oxygen desaturation index (ODI) using 3% drop in oxygen saturation \> 10
• • 3. Currently receiving treatment for insomnia (behavioral or pharmacologic)
• • 4. Currently taking a medication to treat a sleep-related condition (e.g., zolpidem) or unable to discontinue over-the-counter drug or supplement used to treat sleep-related condition
• • 5. Currently taking benzodiazepines or other CNS active medications that may increase risk to the participant, per PI discretion (e.g., opioids other than buprenorphine, antipsychotics)
• • 6. Current DSM-5 diagnosis (any severity) of alcohol or drug use disorder (e.g., benzodiazepine, stimulant) with non-prescribed substance use within last 3 months; nicotine use disorder is not considered exclusionary
• • 7. Cannabis use \> 3 days/week
• • 8. Uncontrolled serious psychiatric disorder that would make study participation unsafe (such as Bipolar I Disorder, ADHD, Schizophrenia, schizoaffective disorders, major depressive disorder with psychotic features, or a neurological disorder).
• • 9. Uncontrolled neurological, cardiovascular, or pulmonary medical condition such as seizure disorder, recent myocardial infarction, stroke, hospitalization for chronic obstructive pulmonary disease
• • 10. Baseline ECG with clinically significant abnormal conduction or with QTc of greater than 450ms
• • 11. Significant current suicidal or homicidal ideation (C-SSRS "yes" answers on questions 4 or 5) or a history of suicide attempt within the past 6 months
• • 12. Any of the following lab abnormalities: ALT/AST 2 or more times the upper limit of normal, Total bilirubin 2 or more times the upper limit of normal, Creatinine 1.5 or more times the upper limit of normal
• • 13. Pregnant or breastfeeding; Females who are having sex that includes penile penetration must be non-pregnant, non-lactating, and either be of non-childbearing potential (e.g., sterilized via hysterectomy, bilateral tubal ligation, or bilateral oophorectomy, or at least 1 year post-menopausal) or of childbearing potential, and agree to use an acceptable form of contraception (e.g., IUD, hormonal implant, hormonal patch/ring/pill, condoms (male or female), etc.)
• • 14. Currently taking prescription or over-the counter drugs or dietary supplements known to significantly inhibit CYP3A4 (such as clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir); or CYP3A4 inducers (such as phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids)
• • 15. Currently taking lemborexant or any previous medically adverse reaction to lemborexant or other dual orexin receptor antagonists
• • 16. Currently incarcerated or pending incarceration