NCT04818086

Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder

Phase Ib/2a Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug Interaction
• Analgesics
• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Lemborexant	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).
DRUG	Placebo	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 is encapsulated to look the same as the intervention drug.
DRUG	Buprenorphine-naloxone	Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.

Timeline

• Start date: 2021-05-03
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2021-03-26
• Last updated: 2024-11-13
• Results posted: 2024-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study