Lemborexant trial to assess sleep, mood, and behavior in Opioid Use Disorder subjects on buprenorphine
Background
Persistent insomnia is a common and debilitating comorbidity in individuals with Opioid Use Disorder (OUD), often remaining unresolved even when OUD is managed with medications like buprenorphine. This residual insomnia can significantly impair quality of life, contribute to relapse risk, and complicate recovery. Current treatments for insomnia in this vulnerable population may have limitations or potential for misuse. Lemborexant, an orexin receptor antagonist, offers a novel mechanism by selectively blocking orexin A and B receptors, which are crucial for maintaining wakefulness, thus promoting sleep without directly targeting GABA pathways like traditional hypnotics.
Study Design
This Phase 2 randomized controlled trial will compare Lemborexant to placebo in 30 estimated participants with Opioid Use Disorder who are currently taking prescribed buprenorphine and experiencing insomnia. Participants will take the study medication (or placebo) nightly for 8 weeks. The study involves 23 visits, including screening, baseline, and post-medication assessments. Primary endpoints will evaluate sleep outcomes, impulsive behavior (via computer tests), and changes in mood and other behaviors. Assessments will include surveys for sleep, drug use, and mood, urine drug testing, vital signs checks, and interviews. Participants will also wear actigraphy watches and keep sleep logs for three two-week periods to track sleep at home.
Results
This Phase 2 randomized controlled trial is currently not yet recruiting, so no results are available. However, the study aims to investigate several key areas regarding Lemborexant in Opioid Use Disorder subjects. The primary objective is to determine the effect of Lemborexant on sleep outcomes in this population. Secondary objectives include assessing the drug's impact on impulsive behavior, measured via computer test performance, and its effects on mood and other behaviors. The trial seeks to compare Lemborexant to placebo over an 8-week treatment period to identify significant improvements in these measures.
The main questions this study aims to answer are: What is the effect of Lemborexant on sleep outcomes? What is the effect of Lemborexant on impulsive behavior (as measured by computer test performance)? What is the effect of Lemborexant on mood and other behavior?
Key Findings
- Study aims to determine Lemborexant's effect on sleep outcomes in OUD subjects.
- Study aims to assess Lemborexant's impact on impulsive behavior via computer tests.
- Study aims to evaluate Lemborexant's effects on mood and other behaviors.
- Trial will compare Lemborexant to placebo over an 8-week treatment period.
Why It Matters
If successful, this study could establish Lemborexant as a valuable adjunct therapy for managing residual insomnia in individuals with Opioid Use Disorder on buprenorphine. Improving sleep quality in this population could significantly enhance overall recovery, reduce cravings, and potentially lower the risk of relapse, offering a non-addictive alternative to traditional sleep aids. The investigation into impulsive behavior and mood also provides a holistic view of Lemborexant's potential benefits beyond just sleep. This trial represents an early-stage clinical investigation (Phase 2), meaning a usable protocol for wider clinical application is still several years away, pending successful completion of this and subsequent larger trials.
lemborexant
insomnia
opioid use disorder
buprenorphine
clinical trial
phase 2