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New IV fentanyl strategy aims to improve opioid addiction treatment

NCT ID NCT05905367

Disease control Sponsor: Pouya Azar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 4 trial tested a new way to start oral opioid addiction therapy for people who use fentanyl. Participants received medically supervised IV fentanyl until comfortable, then were given tailored doses of methadone or slow-release oral morphine. The study enrolled 48 adults with opioid use disorder to see if this approach is safe and helps them stay on treatment longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fentanyl and methadone or slow-release oral morphine
What this could lead to
If successful, this approach could help people with severe fentanyl addiction start and stay on standard oral treatment more effectively.
What could go wrong
This is a small, completed Phase 4 trial with only 48 participants. The IV fentanyl method carries risks like sedation or breathing problems, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

48 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 6. 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 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 4. Current use of methadone \>150mg/day or SROM \>1300mg/day or buprenorphine extended-release in any dose 5. Use of buprenorphine-naloxone within the previous 3 days

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid use disorder

Contacts and locations

Locations

  • Hope to Health Research & Innovation Centre

    Vancouver, British Columbia, V6A 1H2, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.