Fast Facts
Diagnosed & Taking Prescribed Medication for Opioid Use Disorder
Experiencing Sleep Problems
Compensation Provided
Conducted In Richmond, VA
Study Background
Virginia Commonwealth University is investigating the effects of insomnia treatments, including Lemborexant, on sleep patterns, emotional well-being, and behavior in individuals with Opioid Use Disorder who are undergoing medication therapy.
Sleep disturbances are a common challenge for individuals recovering from opioid addiction, particularly for those undergoing treatment with medications like buprenorphine. These sleep issues can have a significant impact on mood, impulsivity, and overall behavior, making recovery even more difficult. To address this, researchers are exploring whether certain insomnia medications, like Lemborexant, can improve sleep quality and provide additional benefits for mental and emotional well-being.
This clinical trial focuses on understanding how Lemborexant affects sleep, mood, and impulsive behaviors in men and women receiving medication treatment for Opioid Use Disorder. By comparing the effects of Lemborexant with a placebo, the study aims to determine whether this medication can lead to measurable improvements in sleep patterns, reduce impulsive tendencies as observed in computer-based tests, and enhance overall mood and behavior over an eight-week treatment period.
Study Background
Virginia Commonwealth University is investigating the effects of insomnia treatments, including Lemborexant, on sleep patterns, emotional well-being, and behavior in individuals with Opioid Use Disorder who are undergoing medication therapy.
Sleep disturbances are a common challenge for individuals recovering from opioid addiction, particularly for those undergoing treatment with medications like buprenorphine. These sleep issues can have a significant impact on mood, impulsivity, and overall behavior, making recovery even more difficult. To address this, researchers are exploring whether certain insomnia medications, like Lemborexant, can improve sleep quality and provide additional benefits for mental and emotional well-being.
This clinical trial focuses on understanding how Lemborexant affects sleep, mood, and impulsive behaviors in men and women receiving medication treatment for Opioid Use Disorder. By comparing the effects of Lemborexant with a placebo, the study aims to determine whether this medication can lead to measurable improvements in sleep patterns, reduce impulsive tendencies as observed in computer-based tests, and enhance overall mood and behavior over an eight-week treatment period.
Additional Information
This study is being done to investigate whether the insomnia medication Lemborexant can improve sleep quality, mood, and impulsive behavior in individuals recovering from opioid addiction who are undergoing medication treatment, as sleep disturbances often hinder recovery and overall well-being.
You may qualify for a study if you meet the following criteria.
Inclusion Criteria:
- Diagnosed with opioid use disorder (OUD)
- Taking medication for OUD
- Experiencing sleep problems
- Ages 18+
If you participate in this study, here’s what you can expect:
Taking the Study Medication
You’ll take either the study medication (Lemborexant) or a placebo (like a sugar pill) every night for 8 weeks.Study Visits
You’ll attend a total of 23 study visits.
Most visits are quick, lasting about 15–30 minutes.
Longer visits include:
Screening Visit (2–3 hours): To determine if you qualify for the study.
Baseline Visit (2.5 hours): To gather starting information.
Post-Medication Visit (2 hours): To assess your experience after 8 weeks of treatment.
Data Collection
During these visits, you’ll:Answer surveys about your sleep, mood, and drug use.
Complete interviews with study staff.
Provide two blood samples: one at the beginning (screening) and one after completing the medication period.
Take part in urine drug tests and have your vital signs (like blood pressure) checked.
Sleep Monitoring at Home
For three separate two-week periods, you’ll wear a watch-like device to monitor your sleep.
You’ll also keep a sleep and wake log during these periods.
As a participant, you will receive compensation for your study participation, including individual study visits.
There is no cost for you to participate in our research study. Transportation is available, if needed.
