Overview

Symptom-inhibited Fentanyl Induction

Status:
Not yet recruiting

Trial end date:
2025-07-01

Target enrollment:
0

Participant gender:
All

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?

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of British Columbia

Treatments:

Fentanyl
Methadone
Morphine

Criteria

Inclusion Criteria:

1. Opioid use disorder (OUD) of any severity by DSM-5 Clinical Diagnostic criteria

2. Intentional use of unregulated fentanyl by any route (injection and/or inhalation) by
participant self-report

3. Urine drug test (UDT) positive for fentanyl at screening or within 7 days prior to
date of screening visit

4. Clinical indication to start OAT with methadone or SROM

5. Willing and able to provide written informed consent for study participation

Exclusion Criteria:

1. Individuals who are pregnant or breast-feeding

2. Currently receiving prescribed fentanyl in any form, e.g. fentanyl patch

3. Previous participation in this study