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NCT06981195 · ClinicalTrials.gov registry record · Phase 2
Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
A Phase 2 study of Opioid Use Disorder and Insomnia, sponsored by Virginia Commonwealth University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06981195 is a Phase 2 study of Opioid Use Disorder and Insomnia that is actively recruiting participants, run by Virginia Commonwealth University. The registered enrollment target is 100 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06981195, a Phase 2 study of Opioid Use Disorder and Insomnia, is actively recruiting participants, sponsored by Virginia Commonwealth University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lemborexant 10 MG
Study Locations (1)
Virginia
- VCU Institute for Drug and Alcohol Studies - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-05-27 |
| Est. Completion | 2029-07-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06981195
The ClinicalTrials.gov registry entry for NCT06981195 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower). The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06981195 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT06981195 about?
NCT06981195 is a clinical study titled "Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects". 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...
What is the current status of trial NCT06981195?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2025-05-27. Estimated completion is 2029-07-30.
What conditions does trial NCT06981195 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Insomnia, Opioid Use, Orexin Antagonist.
What interventions are being tested in trial NCT06981195?
The interventions under investigation include: Placebo (DRUG), Lemborexant 10 MG (DRUG).
Who is sponsoring clinical trial NCT06981195?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06981195 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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