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Opioid Use Disorder
Research Study

Opioid use disorder can affect many parts of a person’s health, including sleep. Many people taking buprenorphine for opioid use disorder continue to have trouble sleeping, but it is not yet known which treatments work best to improve sleep and related mood and behavior. This study will examine whether a medication called lemborexant can improve sleep, mood, and behavior in adults taking buprenorphine for opioid use disorder compared with a placebo.

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Fast Facts

Diagnosed with opioid use disorder (OUD)

Taking ONLY buprenorphine products like suboxone, Brixadi, sublocade

Compensation
provided

Conducted in
Richmond, VA

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Additional Information

This study is being conducted to better understand how a medication called lemborexant affects sleep, mood, and behavior in adults with opioid use disorder who are taking buprenorphine. Researchers hope this study will help identify new ways to improve sleep and overall well-being in this population.

You may be eligible for this study if you meet the following criteria: 

  • Diagnosed with opioid use disorder (OUD)
  • Taking ONLY buprenorphine products like suboxone, Brixadi, sublocade
  • No methadone or vivitrol/naltrexone use
  • Experiencing sleep problems
  • Ages 18+
  • Not currently using nor required to use a CPAP device for the treatment of obstructive sleep apnea
  • Male
  • Female

Overall Duration

The study lasts about 10 weeks. During this time, participants will take the study medication (or a placebo) each night for 8 weeks and complete study visits and at-home activities.

In-Person Study Visits

Participants will come to the study site for a total of 23 visits. Most visits are short and last about 15–30 minutes. Three visits are longer:

  • Screening visit: about 2–3 hours
  • Baseline visit: about 2.5 hours
  • Final visit: about 2 hours

During study visits, participants will:

  • Complete questionnaires about their sleep, mood, and drug use.
  • Meet with study staff for interviews.
  • Have their blood pressure and other vital signs checked.
  • Provide urine samples for drug testing.
  • Complete computer tasks that measure attention and behavior.
  • Provide two blood samples during the study (one at screening and one after completing the study medication).

The research team will collect information from these visits to help answer the study questions. No video or audio recordings will be made.

At-Home Activities

Participants will take the study medication (or placebo) each night for 8 weeks.

For three separate two-week periods, participants will:

  • Wear a watch that tracks their sleep.
  • Keep a daily log of their sleep and wake times.

The sleep watch collects information about sleep and activity only. Study information will be kept private as required by law.

Participants will receive compensation for their time. Transportation assistance is also available, if needed, to help participants attend study visits.

There is no cost for you to participate in our research study.

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