Trial intelligence / Profile preview

Patch BRIDGE

NCT05790252Phase 3

Key facts

Status: Completed
Start: Nov 2023
Primary completion: Aug 2026
Countries: 1
Sponsor: Washington University School of Medicine
Modality: Orthosteric Ligands, Inhalation Devices

Drugs: buprenorphine
Conditions: opioid use disorder (OUD)opioid withdrawal

Overview

Phase 3, randomised, double-blind trial of buprenorphine in opioid use disorder (OUD) and opioid withdrawal (2 arms), sponsored by Washington University School of Medicine. Primary endpoint: Induction withdrawal severity. Started Nov 2023; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Bridge Induction Arm
Patients receive a buprenorphine transdermal matrix patch applied at the time of induction initiation and removed at 48 hours.
Standard Arm
Patients receive a sham patch (bandage) applied at the time of induction initiation and removed at 48 hours.

Who it enrols

Pregnant patients with a viable pregnancy and opioid use disorder who have used opioids within 24 hours and desire buprenorphine treatment. Excludes patients already receiving OUD treatment, with prior buprenorphine induction attempts, active withdrawal, or requiring immediate hospitalization.

Endpoints

Primary

Induction withdrawal severityDays 0-4

Secondary

Induction successDays 0-7
Treatment adherenceDays 0 to delivery
Recovery successDays 0 to delivery

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