Symptom‑inhibited naloxone induction to start buprenorphine/naloxone

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single‑arm, open‑label feasibility study enrolling 12 adults with opioid use disorder who need to start opioid agonist therapy. Clinicians will administer 0.1–0.2 mg IV naloxone every 2 minutes until the patient reaches mild withdrawal (COWS ≥8 with at least two objective signs), then give ≥8 mg sublingual buprenorphine/naloxone and offer a 300 mg subcutaneous extended‑release buprenorphine injection one hour later if withdrawal remains controlled. The protocol collects substance use history, treatment and harm‑reduction utilization, serial COWS/SOWS scores, vital signs, and adverse events to measure feasibility, safety, and tolerability. The intervention is tested in both inpatient and outpatient settings at Vancouver sites with monitored IV access and observation.

Why it matters

Who can join: the full rules

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 consent for study participation.

Exclusion Criteria:

If participants meet any of the following exclusion criteria, they will be excluded from participation in the study:

* Diagnosis of severe medical or psychiatric conditions contraindicated for naloxone or buprenorphine.
* Concomitant use of medications with drug-drug interactions with buprenorphine, unless alternative treatment options are less appropriate and a risk-benefit assessment has been discussed and recommended by the participant's healthcare team.

  o Examples include, but are not limited to: benzodiazepines and non-benzodiazepine central nervous system depressants, naltrexone, CYP3A4 inhibitors and inducers, serotonergic drugs, monoamine oxidase inhibitors, QTc interval-prolonging drugs, diuretics, anticholinergics, and antiretrovirals.
* Known allergy or sensitivity to naloxone or buprenorphine.
* Use of BUP/NLX within the past 9 days.
* Use of BUP-XR within the past 43 weeks.
* Previous participation in this study (previous receipt of SINI in a clinical setting is not exclusionary).
* Currently pregnant or breastfeeding.
* COWS ≥ 8

Where it's running

• Vancouver General Hospital
  Vancouver, British Columbia, Canada Recruiting
• Hope to Health Research & Innovation Centre
  Vancouver, British Columbia, Canada Not yet recruiting

Study contacts

• Principal investigator: Pouya Azar, MD — Department of Psychiatry, Faculty of Medicine, University of British Columbia and Vancouver General Hospital
• Study coordinator: James Wong, MSc
• Email: james.wong@vch.ca
• Phone: (604) 875-5823

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.