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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA059483 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects who are randomized to placebo will receive identical capsules to the test product, administered orally. |
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| Lemborexant | Experimental | Lemborexant (trade name Dayvigo), 10mg capsules, administered orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to end of 8-week treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joyce Ruddley, RN | Contact | 804-827-3784 | study4u@vcu.edu | |
| Tiffany Pignatello, NP | Contact | 804-828-3686 |
| Name | Affiliation | Role |
|---|---|---|
| Caitlin E Martin, MD | Virginia Commonwealth University Institute for Drug and Alcohol Studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VCU Institute for Drug and Alcohol Studies | Recruiting | Richmond | Virginia | 23219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41151943 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2025 | May 6, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000634104 | lemborexant |
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double-blind randomized clinical trial
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| 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 |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | from baseline to end of 8-week treatment |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |