NCT07439549 Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial
| NCT ID | NCT07439549 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Pouya Azar |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 12 participants in total. It began in 2026-04-29 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical study is to evaluate a new treatment approach called symptom inhibited naloxone induction (SINI) for people with opioid use disorder. In this study, participants will receive small doses of intravenous (IV) naloxone at intervals until they feel mild opioid withdrawal symptoms. At this point, they will be given buprenorphine/naloxone under the tongue to help with the withdrawal symptoms. One hour after, they will receive a injection of long acting buprenorphine under the skin if they choose to. The main questions this study aims to answer are: Is it feasible to use the SINI protocol in inpatient and outpatient settings? Is the SINI protocol safe and tolerable for individuals with opioid use disorder?
Eligibility Criteria
Inclusion Criteria: To be eligible for this study, participants must fulfill all the following inclusion criteria: * 19 years of age or older. * Opioid use disorder as confirmed by DSM 5 diagnostic criteria. * Clinical indication to start OAT with buprenorphine. * Willingness to tolerate mild opioid withdrawal precipitated by naloxone, expected to last less than 20 minutes. * Willing and able to have and maintain IV access for the duration of the SINI * If of childbearing potential and elected BUP-XR, agree to use an effective method of birth control. o Highly effective methods of birth control include hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation. Effective methods include barrier methods of contraception (e.g., male condom, female condom, cervical cap, diaphragm, contraceptive sponge). * Willing and able to provide written informed conse
Frequently Asked Questions
Who can join the NCT07439549 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07439549 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07439549 currently recruiting?
Yes, NCT07439549 is actively recruiting participants. Visit ClinicalTrials.gov or contact Pouya Azar to inquire about joining.
Where is the NCT07439549 trial being conducted?
This trial is being conducted at Vancouver, Canada, Vancouver, Canada.
Who is sponsoring the NCT07439549 clinical trial?
NCT07439549 is sponsored by Pouya Azar. The trial plans to enroll 12 participants.