At a glance
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Phase Ib/2a Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
In Brief
A Phase 2 clinical trial evaluating Lemborexant, Placebo, and 1 other intervention for Drug Interaction and 2 related conditions. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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 is encapsulated to look the same as the intervention drug.
Participants will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.