Treatment for opioid use disorder using fentanyl induction
Rapid IV Symptom-inhibited Fentanyl Induction (SIFI) to Facilitate Rotation Onto Oral Opioid Agonist Therapy (OAT)
This study is testing a new treatment for people with opioid use disorder who use fentanyl to see if giving them fentanyl first can help them feel better and stick with their recovery plan.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05905367 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a treatment strategy for individuals with opioid use disorder (OUD) who use fentanyl. Participants will receive medically-administered intravenous (IV) fentanyl until they are comfortable and free from withdrawal symptoms, followed by tailored opioid agonist therapy (OAT) with either methadone or slow-release oral morphine. The study will assess the feasibility and safety of this approach in a community clinic setting, as well as the potential for higher starting doses of OAT that could improve retention in treatment. Monitoring will include sedation levels, withdrawal symptoms, and vital signs throughout the process.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with opioid use disorder who intentionally use unregulated fentanyl.
Not a fit: Patients who are pregnant, currently receiving prescribed fentanyl, or have severe opioid tolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with opioid use disorder who are using fentanyl.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in managing opioid use disorder with tailored treatments, though this specific protocol is novel.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Vancouver, British Columbia
- Hope to Health Research & Innovation Centre — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Pouya Azar, MD — University of British Columbia
- Study coordinator: Marianne Harris, MD
- Email: mharris@bccfe.ca
- Phone: 604-806-8771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.