← Back to Search

Opioid Agonist Therapy

Symptom-inhibited IV fentanyl induction for Opioid Use Disorder (SIFI Trial)

Phase 4

Recruiting

Led By Pouya Azar, MD

Research Sponsored by Pouya Azar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical indication to start OAT with methadone or SROM

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

SIFI Trial Summary

"This trial aims to test a new treatment approach for individuals with opioid use disorder who use fentanyl. Participants will first receive IV fentanyl until they are comfortable and then switch to a standard oral opioid agon

Who is the study for?

This trial is for individuals with opioid use disorder who have used fentanyl intentionally, confirmed by a urine test. They must meet the clinical criteria for OUD and be ready to start treatment with methadone or slow-release oral morphine. Participants need to consent in writing to join the study.Check my eligibility

What is being tested?

The study tests if giving IV fentanyl until withdrawal symptoms stop, followed by daily oral treatments (methadone or slow-release morphine), is safe and effective in a clinic setting. It also checks if this leads to higher starting doses of these medications and helps patients stay on treatment longer.See study design

What are the potential side effects?

Potential side effects may include typical opioid-related risks such as drowsiness, nausea, constipation, addiction potential, respiratory depression (slow breathing), tolerance development, and withdrawal symptoms upon stopping.

SIFI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am starting treatment with methadone or SROM for opioid addiction.

SIFI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after iv fentanyl induction

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after iv fentanyl induction

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after iv fentanyl induction for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Death

Hospitalizations

OAT retention

+5 more

SIFI Trial Design

1Treatment groups

Experimental Treatment

Group I: Symptom-inhibited IV fentanyl inductionExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fentanyl

2019

Completed Phase 4

~1870

Methadone

2005

Completed Phase 4

~2930

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pouya AzarLead Sponsor

University of British ColumbiaLead Sponsor

1,419 Previous Clinical Trials

2,467,117 Total Patients Enrolled

Pouya Azar, MDPrincipal InvestigatorUniversity of British Columbia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being recruited for this study?

"As observed on clinicaltrials.gov, this investigation is presently enrolling volunteers. The trial was initially listed on 1/29/2024 and the most recent update occurred on 4/23/2024."

Answered by AI

What is the upper limit on the number of participants enrolled in this research endeavor?

"Indeed, the information available on clinicaltrials.gov indicates that this investigation is actively seeking suitable candidates. The trial was initially listed on January 29th, 2024, and its most recent update was made on April 23rd, 2024. This research endeavor aims to enroll a total of 50 participants from a single designated site."

Answered by AI

Has the FDA given approval for IV fentanyl induction with symptom inhibition?

"Based on our evaluation, the safety rating for Symptom-inhibited intravenous fentanyl induction is graded as 3. This assessment reflects that the treatment has advanced to Phase 4 status, signifying its approval for use."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Symptom-inhibited Fentanyl Induction

Pouya Azar 2024. "Symptom-inhibited Fentanyl Induction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05905367.