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Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial
Sponsor: Pouya Azar
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?
Official title: Symptom-inhibited Naloxone Induction (SINI) to Initiate Buprenorphine/Naloxone and Buprenorphine Extended-release for Opioid Use Disorder: A Single-arm Feasibility Trial
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-02-18
Completion Date
2026-07-31
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
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.
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).
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).
Locations (2)
Hope to Health Research & Innovation Centre
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada