Trial intelligence / Profile preview

Naloxone-Facilitated Buprenorphine Induction in Fentanyl Users

NCT06089707Phase 3

Key facts

Status: Active, not recruiting
Start: Jan 2024
Primary completion: Jan 2030
Countries: 1
Sponsor: University of Maryland, Baltimore
Modality: Orthosteric Ligands, Inhalation Devices

Drugs: v1003naloxone
Conditions: opioid use disorder (OUD)

Overview

Phase 3, open-label trial of v1003 and naloxone in opioid use disorder (OUD) (4 arms), sponsored by University of Maryland, Baltimore. Primary endpoints: Peak opioid withdrawal as assessed by the Subjective Opiate Withdrawal Scale (SOWS) up to 8 hours, Self-report acceptability at 3 days and 1 more. Started Jan 2024; status: active, not recruiting.

Design

4 arms

Study design: Non-randomizedOpen-label

4mg buprenorphine
Naloxone 4mg IN followed by 4mg buprenorphine
8mg buprenorphine
Naloxone 4mg IN followed by 8mg buprenorphine
16mg buprenorphine
Naloxone 4mg IN followed by 16mg buprenorphine
24mg buprenorphine
Naloxone 4mg IN followed by 24mg buprenorphine

Who it enrols

Adults with moderate to severe opioid use disorder and a fentanyl-positive urine test, who are not currently taking medications for OUD, and have no significant cognitive, psychiatric, or cardiovascular impairments.

Endpoints

Primary

Peak opioid withdrawal as assessed by the Subjective Opiate Withdrawal Scale (SOWS)up to 8 hours
Self-report acceptability3 days
Length of time for participants to reach 8mg of buprenorphineup to 24 hours

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