Naloxone and Buprenorphine for Opioid Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to help individuals with opioid use disorder manage withdrawal symptoms. Participants receive small doses of naloxone until mild withdrawal symptoms appear, then take a combination of buprenorphine and naloxone under the tongue, followed by an optional long-lasting buprenorphine injection. This method, known as Symptom-Inhibited Naloxone Induction (SINI), aims to determine if it is safe and applicable in various settings, such as hospitals or clinics. Individuals with opioid use disorder who are ready to start treatment with buprenorphine and are willing to experience mild withdrawal may be suitable for this trial. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.
Do I have to stop taking my current medications for the trial?
The trial may require you to stop taking certain medications that interact with buprenorphine, like benzodiazepines or some antidepressants, unless your healthcare team decides it's safe to continue. It's best to discuss your current medications with the trial team to see if any changes are needed.
What is the safety track record for the Symptom-Inhibited Naloxone Induction (SINI) protocol?
Research has shown that the Symptom-Inhibited Naloxone Induction (SINI) method, which uses small doses of naloxone followed by a combination of buprenorphine and naloxone, offers a promising way to manage opioid withdrawal. Studies have found that low doses of naloxone can initiate buprenorphine treatment with fewer withdrawal symptoms. This method aims to make withdrawal shorter and easier for patients.
Similar trials, such as those using the symptom-inhibited fentanyl induction, have provided evidence supporting its safety and effectiveness in helping patients begin opioid treatment. Reports from these studies indicate that serious side effects are rare, and any negative effects are usually mild.
The combination of buprenorphine and naloxone is already safely used to treat opioid use disorder. While researchers continue to study the specific SINI method, the individual components are generally well-tolerated. Overall, data suggests that this treatment approach is safe for patients with opioid use disorder.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the Symptom-Inhibited Naloxone Induction (SINI) because it offers a novel approach to treating opioid use disorder. Unlike traditional treatments that often start with buprenorphine alone, this method begins with naloxone induction to manage withdrawal symptoms more effectively before transitioning to buprenorphine/naloxone. This combination could potentially provide a smoother induction process, reducing the discomfort typically experienced during treatment initiation. Additionally, the use of extended-release buprenorphine injection aims to enhance patient compliance and provide sustained relief, which is a significant advancement over daily oral medications.
What evidence suggests that the Symptom-Inhibited Naloxone Induction (SINI) protocol is effective for opioid use disorder?
Research has shown that the Symptom-Inhibited Naloxone Induction (SINI) method, which participants in this trial will receive, effectively manages opioid withdrawal. Studies have found that low-dose intravenous naloxone can shorten withdrawal symptoms, facilitating the switch to buprenorphine. This method allows buprenorphine administration right when mild withdrawal begins, quickly easing symptoms. Previous patients using similar methods successfully transitioned, indicating safety and practicality. Combining this with long-acting buprenorphine helps individuals remain off opioids longer. Overall, the SINI approach appears promising for those dealing with opioid use disorder.34678
Who Is on the Research Team?
Pouya Azar, MD
Principal Investigator
Department of Psychiatry, Faculty of Medicine, University of British Columbia and Vancouver General Hospital
Are You a Good Fit for This Trial?
This trial is for adults (19+) with opioid use disorder who need to start buprenorphine treatment, can give consent, and are willing to have IV access and tolerate mild withdrawal. People can't join if they're pregnant or breastfeeding, recently used certain medications, have severe health issues, or are allergic to naloxone or buprenorphine.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants undergo symptom inhibited naloxone induction (SINI) to initiate buprenorphine/naloxone treatment
Treatment
Participants receive sublingual buprenorphine/naloxone and may opt for extended-release buprenorphine injection
Follow-up
Participants are monitored for safety, effectiveness, and retention on treatment
What Are the Treatments Tested in This Trial?
Interventions
- Symptom-Inhibited Naloxone Induction (SINI)
Trial Overview
The study tests a new way of starting buprenorphine using small IV doses of naloxone until mild withdrawal starts. Then participants get buprenorphine/naloxone under the tongue and may choose a long-acting injection after an hour. The goal is to see if this method is safe and practical.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Symptom inhibited naloxone induction followed by sublingual buprenorphine/naloxone (2/0.5 mg or 8/2 mg) and extended release buprenorphine injection (300mg/1.5mL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pouya Azar
Lead Sponsor
Vancouver General Hospital
Collaborator
VGH and UBC Hospital Foundation
Collaborator
British Columbia Centre for Excellence in HIV/AIDS
Collaborator
Citations
The Pharmacology of Buprenorphine Microinduction for ... - PMC
First, growing observational data has shown that induction onto BUP may precipitate withdrawal, potentially interfering with treatment retention and abstinence ...
Patient-elected low-dose intravenous naloxone for rapid ...
Low-dose intravenous naloxone provides an alternative method of buprenorphine induction that limits the experience of withdrawal to a shorter time window.
Naloxone and Buprenorphine for Opioid Use Disorder
In this study, participants will receive small doses of intravenous (IV) naloxone at intervals until they feel mild opioid withdrawal symptoms.
NCT05905367 | Symptom-inhibited Fentanyl Induction
This is an open-label, single arm, prospective clinical trial involving 50 individuals with opioid use disorder (OUD) who use illicit fentanyl.
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80a7ba3d04f8b71aa576-301909dc4570c350a1649a6d39e3ef3b.ssl.cf1.rackcdn.com/2959522-192590-001.pdfInnovations in Buprenorphine Initiation for the Advanced ...
✹Symptom-Inhibited Naloxone Induction (SINI): Titrates IV naloxone until mild to moderate withdrawal, and then utilizes buprenorphine rescue. ✹Successfully ...
Buprenorphine and Naloxone - StatPearls - NCBI Bookshelf
Buprenorphine-naloxone is a combination medication used in the management and treatment of opioid use disorder.
The efficacy and safety of short-acting, full agonist opioids ...
Introduction: Patients with opioid use disorder often have undertreated withdrawal while in hospital, leading to high rates of premature discharges.
Symptom‐inhibited fentanyl induction (SIFI) onto treatment ...
These results support emerging evidence that SIFI is safe and feasible to meet patients' opioid requirements and facilitate rotation onto OAT.
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