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

NCT06981195 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: HM20031777R01DA059483
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.What is the effect of the study drug (lemborexant) on sleep outcomes?
2. 2.What is the effect of the study drug (lemborexant) on impulsive behavior (as measured by computer test performance)?
3. 3.What is the effect of the study drug (lemborexant) on mood and other behavior?

Conditions

Opioid Use Disorder; Opioid Use; Insomnia; Orexin Antagonist

Keywords

buprenorphine; lemborexant

Outcome Measures

Primary Outcomes (2)

• Insomnia

  Insomnia Severity Index will be used for assessing insomnia related symptoms. Scores on this measure range from 0-28, with higher scores indicating greater symptoms. Mean ISI score per group at baseline and at the end of 8-week treatment will be reported.

  from baseline to end of 8-week treatment

• Impulsivity

  Impulsive responding will be measured by performance on the 5-trial adjusting delay discounting task, with the outcome being a derived discounting rate. Mean delay discounting rate per group at baseline and at the end of 8-week treatment will be reported.

  from baseline to end of 8-week treatment

Secondary Outcomes (8)

• Insomnia related daily sleep metrics: Total sleep time (TST)

  from baseline to end of 8-week treatment

• Insomnia related daily sleep metrics: Wake After Sleep Onset (WASO)

  from baseline to end of 8-week treatment

• Insomnia related daily sleep metrics: Sleep efficiency (SE)

  from baseline to end of 8-week treatment

• Insomnia related daily sleep metrics: Sleep onset latency (SOL)

  from baseline to end of 8-week treatment

• Negative Emotionality: Distress Tolerance Scale (DTS)

  from baseline to end of 8-week treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects who are randomized to placebo will receive identical capsules to the test product, administered orally.

Drug: Placebo

Lemborexant

EXPERIMENTAL

Lemborexant (trade name Dayvigo), 10mg capsules, administered orally

Drug: Lemborexant 10 MG

Interventions

Placebo DRUG

Subjects who are randomized to placebo will receive identical capsules to the study drug. During the 8-week intervention phase, participants will be instructed to take one capsule daily, approximately 5-30 minutes before going to bed

Placebo

Lemborexant 10 MG DRUG

During the 8-week intervention phase, participants will be instructed to take one capsule daily, approximately 5-30 minutes before going to bed

Lemborexant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 or heighten safety risks
• 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)

You may not qualify 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 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
• 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)
• 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 neurological disorder).
• 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 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.)
• 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)
• Currently taking lemborexant or any previous medically adverse reaction to lemborexant or other dual orexin receptor antagonists
• Currently incarcerated or pending incarceration

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

VCU Institute for Drug and Alcohol Studies

Richmond, Virginia, 23219, United States

RECRUITING

Related Publications (1)

• Marcus MM, Alattar M, Chen S, Sabo R, Pignatello T, Ruddley J, Green AR, Swan K, Keyser-Marcus L, Moeller FG, Martin CE. 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. BMJ Open. 2025 Oct 28;15(10):e108613. doi: 10.1136/bmjopen-2025-108613.

  PMID: 41151943 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Sleep Initiation and Maintenance Disorders

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Caitlin E Martin, MD

  Virginia Commonwealth University Institute for Drug and Alcohol Studies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joyce Ruddley, RN

CONTACT

804-827-3784; study4u@vcu.edu

Tiffany Pignatello, NP

CONTACT

804-828-3686

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blind randomized clinical trial

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2029
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

US (1)