Lemborexant for Insomnia
Trial Summary
What is the purpose of this trial?
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.
Research Team
Caitlin E Martin, MD
Principal Investigator
Virginia Commonwealth University Institute for Drug and Alcohol Studies
Eligibility Criteria
This trial is for men and women with Opioid Use Disorder who are currently on prescribed buprenorphine. Participants should be interested in how insomnia treatment might affect their sleep, mood, and behavior. Specific eligibility criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline assessments including surveys, interviews, and initial measurements
Treatment
Participants receive lemborexant or placebo nightly for 8 weeks with regular assessments
Post-medication
Final assessments after completion of medication period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lemborexant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Commonwealth University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator