Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
Condition: Drug Interaction; Analgesics, Opioid
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to test the safety, tolerability, drug interactions
      with buprenorphine-naloxone, and effectiveness lemborexant when used to treat Opioid Use
      Disorder.
    

Detailed description: 
      The purpose of this study is to test the effects of lemborexant when used in combination with
      opioids (including buprenorphine). We are also interested in learning lemborexant might help
      improve sleep problems and problems related to opioid use (e.g., cravings, withdrawal), in
      people with opioid use disorder. Study participants will be randomly assigned in a two to one
      ratio to receive either lemborexant or placebo. Lemborexant (DAYVIGO®) is approved by the U.
      S. Food and Drug Administration (FDA) for treatment of insomnia.

      In this study, Participants will be asked to do the following things:

        1. Visit the CARI clinic and/or Motivate clinic at Jackson Center to complete study
           screening.

        2. Visit the VCUHS Clinical Research Unit to complete an outpatient blood draw/testing
           visit.

        3. Take either lemborexant or the placebo, depending upon which group subjects are assigned
           to.

        4. Complete two (2) overnight study visits at the VCUHS Clinical Research Unit.

        5. Complete 8 outpatient follow-up visits (broken into 2 four day visit groupings)

        6. Have an EKG during screening and at each study visit (outpatient and inpatient)

        7. Have an IV inserted into your arm for blood draws at the outpatient blood draw visit and
           each inpatient visit.

        8. Record sleep in a sleep diary.

        9. Take surveys and answer questions about health, mental health, medications used, drug
           use, and cravings.

       10. Complete tasks on the computer.

       11. Complete physical exams during screening, outpatient and inpatient visits.

       12. Give permission for the researchers to collect information about opioid treatment,
           medical status, and other information from your medical record.

      Participation in this study will last approximately 4 weeks. Approximately 18 people will
      participate in the drug interaction phase of this study.
    

Intervention name(s): Lemborexant; Placebo; Buprenorphine-naloxone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will complete 2 inpatient visits which may last up to 24 hours. The two visits will be approximately 14 days apart. During the inpatient visit they will receive 5 mg of lemborexant (first visit) and 10 mg of lemborexant (second visit).; Participants will complete 2 inpatient visits which may last up to 24 hours. The two visits will be approximately 14 days apart. During the inpatient visit they will receive a placebo which matches the intervention drug.; Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.
Other intervention name(s): Dayvigo
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Lemborexant; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment