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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

May 3, 2021

Primary Completion Date

April 20, 2023

Study Completion Date

April 20, 2023

Conditions
Drug InteractionAnalgesicsOpioid Use Disorder
Interventions
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.

Trial Locations (1)

23298

Virginia Commonwealth University, Richmond

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Virginia Commonwealth University

OTHER