Actively Recruiting
Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial
Led by Pouya Azar · Updated on 2026-05-01
12
Participants Needed
2
Research Sites
22 weeks
Total Duration
On this page
Sponsors
P
Pouya Azar
Lead Sponsor
V
Vancouver General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 19 years of age or older
- Diagnosed with opioid use disorder according to DSM 5 criteria
- Have a clinical reason to start opioid agonist therapy with buprenorphine
- Willing to tolerate mild opioid withdrawal symptoms lasting less than 20 minutes
- Able to have and maintain intravenous (IV) access during the induction process
- If able to get pregnant and choosing extended-release buprenorphine, agree to use effective birth control
- Willing and able to provide written informed consent to participate in the study
You will not qualify if you...
- Severe medical or psychiatric conditions that make naloxone or buprenorphine unsafe
- Taking medications that interact negatively with buprenorphine unless approved by healthcare team
- Known allergy or sensitivity to naloxone or buprenorphine
- Use of buprenorphine/naloxone within the past 9 days
- Use of extended-release buprenorphine within the past 43 weeks
- Previous participation in this study
- Currently pregnant or breastfeeding
- Clinical Opiate Withdrawal Scale (COWS) score of 8 or higher at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hope to Health Research & Innovation Centre
Vancouver, British Columbia, Canada, V6A 1H2
Not Yet Recruiting
2
Vancouver General Hospital
Vancouver, British Columbia, Canada
Actively Recruiting
Research Team
J
James Wong, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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