Symptom-inhibited Fentanyl Induction

NCT05905367 | Completed Phase 4

• 1 other identifier: H23-00111
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Opioid Use Disorder

Keywords

Fentanyl; Methadone; Morphine; Opioid agonist therapy

Outcome Measures

Primary Outcomes (1)

• Number of clinically significant study drug-related adverse events requiring intervention

  Total number of clinically significant study drug-related adverse events (e.g. sedation, respiratory depression, hypoxia, QT prolongation) requiring intervention, occurring during the first week

  Count starting from the beginning of the IV fentanyl induction procedure up to the end of Day 7 on OAT

Secondary Outcomes (8)

• Starting doses of oral OAT

  Immediately after IV fentanyl induction

• OAT retention

  Days 1-7 and 1, 3, 6, and 12 months after IV fentanyl induction

• Participant satisfaction with fentanyl induction

  First 1 to 3 hours after IV fentanyl induction

• Participant satisfaction with current OAT

  Before IV fentanyl induction, and at Day 7 and 1, 3, 6, and 12 months after IV fentanyl induction

• Withdrawal symptoms

  Before, during, and during 1-3 hours after IV fentanyl induction; daily during first week on OAT; and at 1, 3, 6, and 12 months

Study Arms (1)

Symptom-inhibited IV fentanyl induction

EXPERIMENTAL

Symptom-inhibited IV fentanyl induction followed by opioid agonist therapy (OAT) with either oral methadone or slow-release oral morphine (SROM)

Drug: Fentanyl; Drug: Methadone; Drug: Slow-release oral morphine

Interventions

Fentanyl DRUG

Symptom-inhibited IV fentanyl induction

Also known as: Fentanyl citrate, Fentanyl injection

Symptom-inhibited IV fentanyl induction

Methadone DRUG

Opioid agonist therapy (OAT) with methadone at starting doses established by symptom-inhibited IV fentanyl induction

Also known as: Methadone hydrochloride, Methadone oral product

Symptom-inhibited IV fentanyl induction

Slow-release oral morphine DRUG

Opioid agonist therapy (OAT) with SROM at starting doses established by symptom-inhibited IV fentanyl induction

Also known as: SROM, Kadian

Symptom-inhibited IV fentanyl induction

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Opioid use disorder (OUD) of any severity by DSM-5 Clinical Diagnostic criteria
• Intentional use of unregulated fentanyl by any route (injection and/or inhalation) by participant self-report
• Urine drug test (UDT) positive for fentanyl at screening or within 7 days prior to date of screening visit
• Clinical indication to start OAT with methadone or SROM
• Willing and able to provide written informed consent for study participation
• If taking prescribed opioids for safer supply/risk mitigation, willing to discontinue them starting on study Day 1 and for the first 7 days of the study

You may not qualify if:

• Individuals who are pregnant or breast-feeding
• Currently receiving prescribed fentanyl in any form, e.g. fentanyl patch
• Previous participation in this study
• Current use of methadone \>150mg/day or SROM \>1300mg/day or buprenorphine extended-release in any dose
• Use of buprenorphine-naloxone within the previous 3 days

Sponsors & Collaborators

• Pouya Azar: lead

Study Sites (1)

Hope to Health Research & Innovation Centre

Vancouver, British Columbia, V6A 1H2, Canada

Location

Related Publications (1)

• Azar P, Ignaszewski MJ, Harris M, Barazanci Z, Davison R, Wong JSH, Maharaj A, Mathew N, Hall D, Guillemi SA, Foreman J, Barrios R, Montaner JSG. Rapid intravenous symptom-inhibiting fentanyl induction (SIFI) to optimize rotation onto oral opioid agonist therapy among individuals who use unregulated fentanyl: protocol for an open-label, single arm clinical trial. Addict Sci Clin Pract. 2025 Jul 29;20(1):58. doi: 10.1186/s13722-025-00586-7.

  PMID: 40731024 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Fentanyl; Methadone; Morphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ketones; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Pouya Azar, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 15, 2023
• Study Start: January 29, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CA (1)