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New treatment option for Opioid Use Disorder
Official title Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
ClinicalTrials.gov ID: NCT06981195
What this study is testing
What is Lemborexant 10 MG?
Lemborexant 10 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for opioid use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be 18 + years-of-age
- Meet current DSM-5 criteria for opioid use disorder (OUD) with at least moderate severity
- Receiving outpatient treatment for OUD with sublingual buprenorphine film/tablets ranging 8mg to 24mg or with extended-release injectable...
- Stabilized on current buprenorphine dosage for at least 4 weeks without intention for dose change within next 3 months.
- Screening urine toxicology positive for buprenorphine and an appropriate norbuprenorphine level as determined by a study clinician
You likely can't join if
- Current diagnosis of sleep-related breathing disorder, narcolepsy, somnambulism, or sleep paralysis
- A positive screen for sleep apnea by the following: Sleep Disorders Screening Battery (STOP-BAG \>5) OR home sleep apnea test using WatchPAT with...
- Currently receiving treatment for insomnia (behavioral or pharmacologic)
- Currently taking a medication to treat a sleep-related condition (e.g., zolpidem) or unable to discontinue over-the-counter drug or supplement used...
- Currently taking benzodiazepines or other CNS active medications that may increase risk to the participant, per PI discretion (e.g., opioids other...
- Current DSM-5 diagnosis (any severity) of alcohol or drug use disorder (e.g., benzodiazepine, stimulant) with non-prescribed substance use within...
See the full eligibility criteria
- Be 18 + years-of-age
- Meet current DSM-5 criteria for opioid use disorder (OUD) with at least moderate severity
- Receiving outpatient treatment for OUD with sublingual buprenorphine film/tablets ranging 8mg to 24mg or with extended-release injectable buprenorphine
- Stabilized on current buprenorphine dosage for at least 4 weeks without intention for dose change within next 3 months.
- Screening urine toxicology positive for buprenorphine and an appropriate norbuprenorphine level as determined by a study clinician
- A screening urine toxicology negative for non-prescribed substances (except cannabinoids) with a negative breath (or oral fluid) alcohol screen
- Screen positive for chronic insomnia on the Insomnia Symptom Questionnaire (ISQ)
- Have an Insomnia Severity Index score at screening and baseline of 13 or higher
- 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...
- Understand the study procedures and provide written informed consent in English language
- Access to necessary resources for completing virtual surveys and monitoring (i.e., computer or smartphone, internet or cell service)
- Current diagnosis of sleep-related breathing disorder, narcolepsy, somnambulism, or sleep paralysis
- 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...
- Currently receiving treatment for insomnia (behavioral or pharmacologic)
- 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
- 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)
- 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
- Cannabis use \> 3 days/week
- 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...
- Uncontrolled neurological, cardiovascular, or pulmonary medical condition such as seizure disorder, recent myocardial infarction, stroke, hospitalization for chronic obstructive pulmonary disease
- Baseline ECG with clinically significant abnormal conduction or with QTc of greater than 450ms
- 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
- 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
- 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...
- 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...
- Currently taking lemborexant or any previous medically adverse reaction to lemborexant or other dual orexin receptor antagonists
- Currently incarcerated or pending incarceration
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.