Study of Lemborexant Effects on Sleep, Mood, and Behavior in Adults with Opioid Use Disorder Taking Buprenorphine

What this Trial Is About

Researchers are studying how certain medications used to treat insomnia, including lemborexant, affect sleep, mood, and behavior in adults with Opioid Use Disorder who are taking prescribed buprenorphine. The study aims to understand the effects of lemborexant compared to a placebo over an 8-week treatment period, focusing on sleep quality, impulsive behavior, and mood changes. Participants will be randomly assigned to receive either lemborexant 10 mg capsules or matching placebo capsules, taken orally once daily about 5 to 30 minutes before bedtime for 8 weeks. The study includes a total of 23 visits with various assessments, including urine drug tests, vital signs, interviews, and sleep monitoring using a wearable watch and sleep logs during three separate two-week periods. During the study, participants will complete surveys on sleep, drug use, and mood, provide blood samples at screening and post-medication, and undergo regular evaluations. Researchers will measure changes in insomnia and impulsivity from baseline through the end of treatment, along with other sleep metrics and emotional health questionnaires. Safety and adherence will be closely monitored throughout the trial, which lasts for the entire 8-week treatment period plus screening and follow-up visits.

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