Trial intelligence / Profile preview

Lemborexant for Opioid Use Disorder

NCT04818086Phase 2

Key facts

Status: Completed
Start: May 2021
Primary completion: Apr 2023
Countries: 1
Sponsor: Virginia Commonwealth University
Modality: Small Molecules

Drugs: lemborexant
Conditions: opioid use disorder (OUD)Insomnia

Overview

Phase 2, randomised, double-blind trial in opioid use disorder (OUD) and Insomnia comparing Lemborexant Arm with Placebo Arm (2 arms). Primary endpoints: Change in Pulse Oximetry at 2 weeks, Change in Blood Pressure at 2 weeks and 4 more. Started May 2021; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Lemborexant Arm
Lemborexant (5mg then 10mg) + Buprenorphine/Naloxone (16mg/4mg)
Placebo Arm
Placebo + Buprenorphine/Naloxone (16mg/4mg)

Who it enrols

Adults aged 18-65 with moderate to severe opioid use disorder currently on stable buprenorphine-naloxone treatment and experiencing sleep disturbances (PSQI >= 6).

Endpoints

Primary

Change in Pulse Oximetry2 weeks
Change in Blood Pressure2 weeks
Change in Patient Consciousness2 weeks
Change in Buprenorphine Plasma Concentration2 weeks
Change in Lemborexant Pharmacokinetics2 weeks

Secondary

Change in Drug Effects2 weeks
Change in Opioid Craving2 weeks
Change in Subjective Opioid Withdrawal Effects2 weeks
Change in Objective Opioid Withdrawal2 weeks
Change in Impulsivity2 weeks

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