Opioid Use DisorderPhase 2NCT06981195
Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
A Phase 2 study testing Lemborexant 10 MG in people with Opioid Use Disorder and Opioid Use, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Opioid Use, Insomnia
- What is being tested?
- Lemborexant 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2025to 30 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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)
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tiffany Pignatello, NP contact
United States1 site, 1 recruiting
- Recruiting
VCU Institute for Drug and Alcohol Studies
Richmond, Virginia, 23219
About this study
Official title: 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
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:
- What is the effect of the study drug (lemborexant) on sleep outcomes?
- What is the effect of the study drug (lemborexant) on impulsive behavior (as measured by computer test performance)?
- What is the effect of the study drug (lemborexant) on mood and other behavior?
Read more
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
- Opioid Use Disorder, Opioid Use, Insomnia, Orexin Antagonist
- Being tested
- Placebo, Lemborexant 10 MG
- Keywords
- buprenorphine, lemborexant
- Medical subject headings
- Opioid-Related Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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
Lemborexant 10 MGDrug
During the 8-week intervention phase, participants will be instructed to take one capsule daily, approximately 5-30 minutes before going to bed
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects who are randomized to placebo will receive identical capsules to the test product, administered orally. Receives: Drug: Placebo |
| Lemborexant | Experimental | Lemborexant (trade name Dayvigo), 10mg capsules, administered orally Receives: Drug: Lemborexant 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from baseline to end of 8-week treatment
Secondary outcomes (8)
Insomnia related daily sleep metrics: Total sleep time (TST)
Total sleep time (TST) will be derived from actigraphy measured by an actigraphy watch. The descriptive statistics of derived TST score per group at baseline and end of 8-week treatment will be reported.
Measured: from baseline to end of 8-week treatment
Insomnia related daily sleep metrics: Wake After Sleep Onset (WASO)
Wake After Sleep Onset (WASO), will be derived from actigraphy measured by an actigraphy watch. The descriptive statistics of derived WASO score per group at baseline and end of 8-week treatment will be reported.
Measured: from baseline to end of 8-week treatment
Insomnia related daily sleep metrics: Sleep efficiency (SE)
Sleep efficiency (SE) will be derived from actigraphy measured by an actigraphy watch. The descriptive statistics of derived SE score per group at baseline and end of 8-week treatment will be reported.
Measured: from baseline to end of 8-week treatment
Insomnia related daily sleep metrics: Sleep onset latency (SOL)
Sleep onset latency (SOL) will be derived from actigraphy measured by an actigraphy watch. The descriptive statistics of derived SOL score per group at baseline and end of 8-week treatment will be reported.
Measured: from baseline to end of 8-week treatment
Negative Emotionality: Distress Tolerance Scale (DTS)
The Distress Tolerance Scale will be used as a measure of negative emotionality. The DTS is a 15-item, 5-point Likert scale measure with item scores ranging from 1-5. Lower scores indicate greater distress tolerance. Mean DTS score per group at baseline and at the end of 8-week treatment will be reported.
Measured: from baseline to end of 8-week treatment
Negative Emotionality: Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief (9-item) measure of depressive symptoms. Scores range from 1-27, with higher scores indicating greater severity of depressive symptoms. Mean PHQ-9 score per group at baseline and at the end of 8-week treatment will be reported.
Measured: from baseline to end of 8-week treatment
Negative Emotionality: General Anxiety Disorder (GAD-7)
The GAD-7 is a brief (7-item) measure of anxiety symptoms. Scores range from 0-21, with higher scores indicating greater severity of anxiety symptoms. Mean GAD-7 score per group at baseline and at the end of 8-week treatment will be reported.
Measured: from baseline to end of 8-week treatment
Metacognition: Metacognitions Questionnaire (MCQ-30)
The MCQ-30 a brief (30-item) measure of metacognition. Total scores range from 30-120, with higher scores indicating greater magnitude of problematic metacognitions. Mean MCQ-30 score per group at baseline and at the end of 8-week treatment will be reported.
Measured: from baseline to end of 8-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start27 May 2025
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Caitlin E Martin, MD, Principal investigator, Virginia Commonwealth University Institute for Drug and Alcohol Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981195
- Sponsor's protocol ID
- HM20031777
- Other IDs
- R01DA059483
- Status last verified
- Jun 2026
- First submitted
- 12 May 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41151943
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06981195
- Acronym / sponsor ID
- HM20031777
- Conditions
- Opioid Use Disorder, Opioid Use, Insomnia, Orexin Antagonist
- Keywords
- buprenorphine, lemborexant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 27 May 2025 (actual)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the effect of the study drug (lemborexant) on sleep outcomes?
- What is the effect of the study drug (lemborexant) on impulsive behavior (as measured by computer test performance)?
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects who are randomized to placebo will receive identical capsules to the test product, administered orally. |
| Lemborexant | Experimental | Drug: Lemborexant 10 MGLemborexant (trade name Dayvigo), 10mg capsules, administered orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSubjects 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 | Drug | Placebo |
| Lemborexant 10 MGDuring the 8-week intervention phase, participants will be instructed to take one capsule daily, approximately 5-30 minutes before going to bed | Drug | Lemborexant |
Primary outcome
Insomnia
Time frame: from baseline to end of 8-week treatment
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.
Impulsivity
Time frame: from baseline to end of 8-week treatment
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.
8 secondary outcomes
Insomnia related daily sleep metrics: Total sleep time (TST)
Time frame: from baseline to end of 8-week treatment
Insomnia related daily sleep metrics: Wake After Sleep Onset (WASO)
Time frame: from baseline to end of 8-week treatment
Insomnia related daily sleep metrics: Sleep efficiency (SE)
Time frame: from baseline to end of 8-week treatment
Insomnia related daily sleep metrics: Sleep onset latency (SOL)
Time frame: from baseline to end of 8-week treatment
Negative Emotionality: Distress Tolerance Scale (DTS)
Time frame: from baseline to end of 8-week treatment
Negative Emotionality: Patient Health Questionnaire (PHQ-9)
Time frame: from baseline to end of 8-week treatment
Negative Emotionality: General Anxiety Disorder (GAD-7)
Time frame: from baseline to end of 8-week treatment
Metacognition: Metacognitions Questionnaire (MCQ-30)
Time frame: from baseline to end of 8-week treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Derived from this study: PubMed 41151943Marcus 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.
- Individual participant dataSharing planned: Undecided
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiffany Pignatello, NP contact
Caitlin E Martin, MD principal investigator
Virginia Commonwealth University Institute for Drug and Alcohol Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lemborexant 10 MG in people with Opioid Use Disorder and Opioid Use, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joyce Ruddley, RN (804-827-3784, study4u@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia (time frame: from baseline to end of 8-week treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06981195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.