NCT07439549

Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial

Symptom-inhibited Naloxone Induction (SINI) to Initiate Buprenorphine/Naloxone and Buprenorphine Extended-release for Opioid Use Disorder: A Single-arm Feasibility Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Pouya Azar · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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?

Detailed description

This is a prospective, single arm, open label, feasibility study involving 12 participants with opioid use disorder who have a clinical indication to start opioid agonist therapy with buprenorphine. Eligible participants provide informed consent will undergo buprenorphine induction using the symptom inhibited naloxone induction protocol (SINI). A study doctor or nurse will administer 0.1 - 0.2 mg of intravenous naloxone every 2 minutes until the patient is in mild opioid withdrawal, defined as a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 and at least two objective withdrawal signs not attributable to other causes. Once this is level of opioid withdrawal is achieved, ≥ 8 mg of sublingual buprenorphine/naloxone (BUP/NLX) will be administered consistent with the recommended minimum induction dose in the product monograph and published high dose induction strategies. If the patient opts for extended release buprenorphine treatment (BUP-XR) and their COWS score has not increased by more than 5 points one hour after sublingual buprenorphine/naloxone administration, a 300 mg dose of BUP-XR will be administered subcutaneously one hour after their sublingual BUP/NLX. The following information will the collected * Substance use history * Substance use treatment utilization * Harm reduction service utilization * Clinical Opiate Withdrawal Scores / Subjective Opiate Withdrawal Scores * Vital Signs (Heart rate, blood pressure, respiratory rate, oxygen saturation) * Adverse events * Treatment satisfaction questionnaire for medication (TSQM) Following the SINI protocol, participants receiving sublingual BUP/NLX treatment, ongoing medication dispensing will transition to a community pharmacy in accordance with standard clinical practice. Participants receiving subcutaneous BUP/XR treatment, subsequent doses will be administered either at a CPAS physician's office, clinic, or pharmacy, as per standard clinical practice. Participants will be followed for 28 days, during which the information listed below will be collected. * Retention on BUP/NLX or BUP-XR, or other forms of OAT * Unregulated opioid use * Rates of overdose and hospitalization * Adverse events

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Naloxone Hydrochloride 0.4 MG/ML	0.1 mg naloxone is administered IV every 2 minutes until mild symptoms with COWS ≥ 8 and at least two objective withdrawal signs not attributable to other causes. If fourth and subsequent doses are needed, and withdrawal symptoms are not emerging or are progressing too slowly, the dose may be increased to 0.2 mg based on clinical judgment.
DRUG	Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg)	If the patient opts for BUP/NLX treatment, ≥ 2 mg BUP/NX will be administered under the tongue Q1-3H PRN for withdrawal/pain/cravings. The total dose administered on the first day determines the starting dose for Day 2. If symptoms persist on Day 2, extra doses can be given until stable, and that total amount on Day 2 becomes the new maintenance dose (Maximum dose: 32 mg/day).
DRUG	Buprenorphine extended-release injection (300 mg/1.5 mL)	If the patient opts for BUP-XR, 1 hour after the administration of sublingual buprenorphine/naloxone, study nurse or physician will subcutaneously administer buprenorphine extended-release injection (300 mg/1.5 mL).

Timeline

• Start date: 2026-02-18
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

2 sites across 1 country: Canada