Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Virginia Commonwealth University
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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).
Where it's recruiting
Richmond
Source: ClinicalTrials.gov · NCT06981195 · last updated 2025-06-29