Actively Recruiting
Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
Led by Virginia Commonwealth University · Updated on 2025-06-29
100
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn about how certain medications used to treat insomnia (e.g., Lemborexant) impact sleep, mood, and behavior in men and women with Opioid Use Disorder who are taking prescribed buprenorphine. The main questions it aims to answer are: 1. What is the effect of the study drug (lemborexant) on sleep outcomes? 2. What is the effect of the study drug (lemborexant) on impulsive behavior (as measured by computer test performance)? 3. What is the effect of the study drug (lemborexant) on mood and other behavior? Researchers will compare lemborexant to placebo (e.g., sugar pill) to see if participants assigned to 8 weeks of treatment with lemborexant have greater improvements on the measures listed above. Participants will take the study medication (or placebo) each night for 8 weeks and be asked to come for a total of 23 study visits. Most of these visits will be very short (15-30 minutes). The longer visits will include the screening visit (about 2-3 hrs), baseline visit (about 2.5 hrs), and the post-medication visit (about 2 hrs). Study visits will include things like taking surveys about sleep, drug use, and mood, completing urine drug testing, checking vital signs (e.g., blood pressure), and completing interviews with the study staff. Participants will also be asked to provide two blood samples (one during screening and one after taking the medication). For three two-week periods, participants will be asked to wear a watch to track sleep at home, and to keep a log of sleep and wake times.
CONDITIONS
Official Title
Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
Who Can Participate
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 with no planned dose change in next 3 months
- Screening urine test positive for buprenorphine and appropriate norbuprenorphine level
- Screening urine test negative for non-prescribed substances (except cannabinoids) and negative alcohol screen
- 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 conditions preventing participation or increasing safety risk
- Understand study procedures and provide written informed consent in English
- Have 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 specified tests or oxygen desaturation criteria
- Currently receiving treatment for insomnia or taking medications for sleep-related conditions
- Taking benzodiazepines or other CNS active medications that increase risk
- Current diagnosis of alcohol or drug use disorder with non-prescribed substance use in last 3 months (nicotine use disorder allowed)
- Cannabis use more than 3 days per week
- Uncontrolled serious psychiatric disorders (e.g., Bipolar I, ADHD, Schizophrenia, major depressive disorder with psychotic features)
- Uncontrolled neurological, cardiovascular, or pulmonary conditions
- Baseline ECG with significant abnormal conduction or QTc over 450ms
- Significant current suicidal or homicidal thoughts or recent suicide attempt
- Certain lab abnormalities (e.g., elevated liver enzymes or creatinine)
- Pregnant, breastfeeding, or not using acceptable contraception if of childbearing potential
- Taking medications that strongly inhibit or induce CYP3A4
- Currently taking or previously had adverse reaction to lemborexant or similar drugs
- Currently incarcerated or pending incarceration
AI-Screening
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Trial Site Locations
Total: 1 location
1
VCU Institute for Drug and Alcohol Studies
Richmond, Virginia, United States, 23219
Actively Recruiting
Research Team
J
Joyce Ruddley, RN
CONTACT
T
Tiffany Pignatello, NP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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