Lemborexant for Insomnia in Opioid Use Disorder
This study is looking at how lemborexant, a medication for insomnia (trouble sleeping), affects sleep, mood, and behavior in people with Opioid Use Disorder (OUD). Participants must be at least 18 years old, have moderate to severe OUD, and be currently taking buprenorphine for their OUD. The study aims to see if lemborexant improves sleep, reduces impulsive behavior (acting without thinking), and positively impacts mood compared to a placebo (an inactive pill). Researchers will compare these effects over an 8-week treatment period. The current status of this study is unclear, and it plans to enroll 100 participants.
- Study design
- This is an interventional study comparing lemborexant to a placebo. It plans to enroll 100 participants.
- What's involved
- Participants will take one capsule daily, either lemborexant or placebo, for 8 weeks, approximately 5-30 minutes before bed.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured from baseline to the end of the 8-week treatment period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Caitlin E Martin, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University Institute for Drug and Alcohol Studies
Who to contact
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What this trial measures
- Insomniafrom 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.
- Impulsivityfrom 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.