Neurofunctional Phenotyping to Investigate the Role of the Orexin System at the Intersection of Opioid Use Disorder and Insomnia Among Women and Men Receiving Buprenorphine
Led by Virginia Commonwealth University · Updated on 2025-06-29
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Virginia Commonwealth University
Lead Sponsor
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National Institute on Drug Abuse (NIDA)
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What this Trial Is About
Researchers are evaluating how certain medications for insomnia, specifically lemborexant, affect sleep, mood, and behavior in adults with Opioid Use Disorder who are taking prescribed buprenorphine. This Phase 2 clinical trial aims to understand the impact of lemborexant on sleep outcomes, impulsive behavior measured through computer tests, and mood changes by comparing it to a placebo over an eight-week period.
Participants will take either lemborexant 10mg capsules or identical placebo capsules orally each night for eight weeks, about 5 to 30 minutes before bedtime. The study includes 23 visits, mostly brief, with longer visits for screening, baseline assessment, and post-medication evaluation. During the study, participants wear a sleep tracking watch for three two-week periods and keep logs of their sleep and wake times.
Throughout the trial, participants complete surveys on sleep, drug use, and mood, provide urine drug tests and blood samples, and have vital signs checked. The main outcomes measured are insomnia severity and impulsivity from baseline to the end of treatment. Additional measures include daily sleep patterns and mood assessments. Safety is monitored via physical exams, interviews, and laboratory tests, with total participation lasting about eight weeks of treatment plus screening and follow-up visits.
CONDITIONS
Brief Title
Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Be 18 years of age or older
Meet current DSM-5 criteria for opioid use disorder with at least moderate severity
Receiving outpatient treatment for opioid use disorder with sublingual buprenorphine (8mg to 24mg) or extended-release injectable buprenorphine
Stabilized on current buprenorphine dose for at least 4 weeks without planned dose change for next 3 months
Screening urine positive for buprenorphine and appropriate norbuprenorphine level
Screening urine negative for non-prescribed substances (except cannabinoids) and negative alcohol breath/oral fluid test
Screen positive for chronic insomnia on the Insomnia Symptom Questionnaire
Insomnia Severity Index score of 13 or higher at screening and baseline
No clinically significant medical or psychiatric disorder that would prevent participation or increase safety risks
Understand study procedures and provide written informed consent in English
Access to computer or smartphone and internet or cell service for virtual surveys and monitoring
You will not qualify if you...
Current diagnosis of sleep-related breathing disorder, narcolepsy, somnambulism, or sleep paralysis
Positive screen for sleep apnea by Sleep Disorders Screening Battery or home sleep apnea test with specific criteria
Currently receiving treatment for insomnia (behavioral or pharmacologic)
Currently taking medication or supplements for sleep-related conditions that cannot be discontinued
Currently taking benzodiazepines or other CNS active medications that may increase risk
Current diagnosis of alcohol or drug use disorder (other than nicotine) with non-prescribed use within last 3 months
Cannabis use more than 3 days per week
Uncontrolled serious psychiatric disorders such as Bipolar I, ADHD, Schizophrenia, or major depressive disorder with psychotic features
Uncontrolled neurological, cardiovascular, or pulmonary conditions
Abnormal baseline ECG with QTc greater than 450ms
Significant suicidal or homicidal ideation or recent suicide attempt
Certain lab abnormalities including elevated liver enzymes or creatinine
Pregnant or breastfeeding females; females of childbearing potential must use contraception
Taking drugs or supplements that strongly inhibit or induce CYP3A4 enzymes
Prior adverse reaction to lemborexant or similar orexin receptor antagonists
Currently incarcerated or pending incarceration
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants take one capsule daily, approximately 5-30 minutes before going to bed, for 8 weeks. This includes either the study drug Lemborexant or a placebo.
Neurofunctional phenotyping to investigate the role of the orexin system at the intersection of opioid use disorder and insomnia: a protocol for a randomised, placebo-controlled clinical trial of lemborexant in patients with insomnia receiving buprenorphine.
