RecruitingPHASE4INTERVENTIONAL

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

This study is looking at a new way to start treatment for people with opioid use disorder, called Symptom-Inhibited Naloxone Induction (SINI). First, small doses of naloxone are given through a drip until mild withdrawal symptoms appear. Then, a medicine called buprenorphine/naloxone is given under the tongue to manage these symptoms and begin treatment. Some people may also receive a long-lasting buprenorphine injection. The main goal is to find out if this SINI method is safe, manageable for patients, and practical to use in different healthcare settings. This is important for finding better ways to help people start their recovery journey from opioid use disorder.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Pouya Azar

Enrolment target

Start

29 Apr 2026

Estimated completion

30 Sep 2026

Opioid Use Disorder

What is this study about?

This study is exploring a new method to help people start treatment for opioid use disorder. Opioid use disorder is a serious medical condition where someone relies on opioids, which are strong pain medicines, and finds it very difficult to stop using them.

The usual way to start treatment with medicines like buprenorphine can be tricky because you usually have to be in significant opioid withdrawal first, which can be uncomfortable. This new method, called Symptom-Inhibited Naloxone Induction (SINI), tries a different approach. The idea is to carefully give small amounts of a medicine called naloxone. Naloxone helps bring on mild opioid withdrawal symptoms in a controlled way. Once these mild symptoms start, you quickly receive buprenorphine/naloxone under your tongue. This medicine is designed to ease the withdrawal symptoms and begin your ongoing treatment.

After this, if you choose, you might also get a long-acting buprenorphine injection under your skin. This injection releases the medicine slowly over time, making it easier to stick to treatment. The main reasons for doing this study are to check if this SINI method is safe, whether people can tolerate it well, and if it's practical for doctors and nurses to use both in hospital settings and in clinics. Finding better and more comfortable ways to start treatment can be a big step forward for people on their recovery path.

Key takeaways

This study evaluates a new way to start opioid use disorder treatment.
It uses naloxone to bring on mild withdrawal, then buprenorphine to treat it.
The goal is a safer, more comfortable start to buprenorphine treatment.
It's testing if this method is practical and well-tolerated.
Participation involves close monitoring during treatment initiation.

Who may be eligible?

To join this study, you need to be at least 19 years old and have been diagnosed with opioid use disorder by a doctor. You should also be planning to start treatment with buprenorphine medicines.

It's important that you are willing and able to experience mild opioid withdrawal symptoms caused by the naloxone. These symptoms are expected to be short-lived, lasting less than 20 minutes. You also need to be able to have an IV (a small tube in your vein) for part of the process and give your written consent to take part.

There are also some reasons why you might not be able to join. For example, if you have severe medical or mental health issues that could make naloxone or buprenorphine unsafe for you. Also, if you're taking certain medicines that could react badly with buprenorphine, or if you've already used buprenorphine treatments very recently, you might not be eligible. If you're a woman who could get pregnant and choose the long-acting injection, you'll need to agree to use effective birth control.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 19 years old or older?
Have you been diagnosed with opioid use disorder?
Are you planning to start buprenorphine treatment?
Are you willing to experience mild, temporary withdrawal symptoms?
Can you have an IV line placed for the procedure?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll start the SINI process. This involves a doctor or nurse giving you small doses of naloxone through an IV, every two minutes. They'll keep doing this until you show mild signs of opioid withdrawal. As soon as you reach this point, you will be given a buprenorphine/naloxone tablet to dissolve under your tongue. This helps manage the withdrawal symptoms.

About an hour later, if you choose and your withdrawal symptoms haven't worsened too much, you might receive a long-acting buprenorphine injection under your skin. Throughout this process, the study team will regularly check how you're feeling, your vital signs (like heart rate and blood pressure), and your withdrawal symptoms using a special score. They will also ask about your past substance use and how satisfied you are with the treatment.

After the initial SINI process, if you're receiving the daily buprenorphine/naloxone tablets, your treatment will continue at a local pharmacy, similar to standard care. If you received the long-acting injection, follow-up doses will be given at a clinic or doctor's office. You will be followed for a total of 28 days to see how you are doing.

Potential risks and benefits

Participating in this study could offer a new, potentially more comfortable way to start treatment for opioid use disorder, which could be a significant benefit in your recovery journey. The main risk involves experiencing mild opioid withdrawal symptoms due to naloxone, though this is carefully monitored and quickly followed by medication to ease discomfort. There's also a chance of side effects from the study medications, which will be discussed with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Hope to Health Research & Innovation Centre
Verified postcode
Vancouver, Canada· Not yet recruiting
Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is opioid use disorder?

It's a medical condition where someone has trouble controlling their use of strong pain medicines (opioids) and continues to use them despite negative effects on their life.

What is naloxone?

Naloxone is a medicine that quickly blocks the effects of opioids. In this study, small amounts are used to bring on mild withdrawal symptoms so buprenorphine treatment can start.

What is buprenorphine?

Buprenorphine is a medicine used to treat opioid use disorder. It helps reduce cravings and withdrawal symptoms, supporting recovery.

Will I have to stay in a hospital?

The study aims to see if this method can be used both in hospital (inpatient) and clinic (outpatient) settings, so it depends on the specific setup for your participation.

How long will I be involved in the study?

After the initial treatment start, you will be followed for a total of 28 days to see how you are progressing.

How to find out more

James Wong, MSc

james.wong@vch.ca (604) 875-5823 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.