drugset / Trial / NCT05905367

Symptom-inhibited Fentanyl Induction

NCT05905367

Phase 4 Completed 48 enrolled Pouya Azar
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to test a treatment strategy for individuals with opioid use disorder (OUD) who use fentanyl. Participants will receive medically-administered doses of intravenous (IV) fentanyl at intervals until they are comfortable and do not have withdrawal symptoms. They then will be given opioid agonist therapy (OAT) once daily by mouth, which is the current standard treatment for OUD. In this trial, each participant's starting dose of OAT will be tailored to meet their opioid needs, based on the amount of IV fentanyl they received. The main questions this trial aims to answer are: * Is the IV fentanyl protocol feasible and safe for use in a community clinic setting? * Will the protocol result in higher-than-standard starting doses of OAT? Are these doses safe, and will they enable participants to stay on OAT for a longer time?

Timeline

Start
2024-01-29
Primary completion
2025-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified Intravenous
Subject Methadone Other / unclassified Oral
Subject Morphine Other / unclassified Oral