New approach aims to make starting opioid addiction treatment easier
NCT ID NCT07439549
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new approach called SINI to help people with opioid use disorder start buprenorphine treatment more comfortably. Participants receive small doses of naloxone to trigger mild withdrawal, then take buprenorphine to ease symptoms, followed by a long-acting injection. The goal is to see if this method is safe and practical in both hospital and outpatient settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hope to Health Research & Innovation Centre
NOT_YET_RECRUITINGVancouver, British Columbia, V6A 1H2, Canada
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Vancouver General Hospital
RECRUITINGVancouver, British Columbia, Canada
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