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Opioid Agonist Therapy

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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal 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.
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.
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.

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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of clinically significant study drug-related adverse events requiring intervention
Secondary study objectives
Death
Hospitalizations
OAT retention
+5 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~1920
Methadone
2002
Completed Phase 4
~4460

Find a Location

Who is running the clinical trial?

Pouya AzarLead Sponsor
University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,406 Total Patients Enrolled
Pouya Azar, MDPrincipal InvestigatorUniversity of British Columbia
~0 spots leftby Dec 2024
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