Opioid Use DisorderPhase 4NCT07439549
Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial
A Phase 4 study testing Naloxone Hydrochloride 0.4 MG/ML, Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg) and Buprenorphine extended-release injection (300 mg/1.5 mL) in people with Opioid Use Disorder, run by Pouya Azar at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Naloxone Hydrochloride 0.4 MG/ML, Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg) and Buprenorphine extended-release injection (300 mg/1.5 mL)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesCanada
- Study dates
- 29 Apr 2026to 30 Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
Hope to Health Research & Innovation Centre
Vancouver, British Columbia, V6A 1H2
James Wong, MSc, (604) 875-5823, james.wong@vch.ca
Pouya Azar, MD
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
James Wong, MSc, (604) 875-5823, james.wong@vch.ca
Pouya Azar, MD
About this study
Official title: Symptom-inhibited Naloxone Induction (SINI) to Initiate Buprenorphine/Naloxone and Buprenorphine Extended-release for Opioid Use Disorder: A Single-arm Feasibility Trial
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?
Read the detailed description
This is a prospective, single arm, open label, feasibility study involving 12 participants with opioid use disorder who have a clinical indication to start opioid agonist therapy with buprenorphine. Eligible participants provide informed consent will undergo buprenorphine induction using the symptom inhibited naloxone induction protocol (SINI). A study doctor or nurse will administer 0.1 - 0.2 mg of intravenous naloxone every 2 minutes until the patient is in mild opioid withdrawal, defined as a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 and at least two objective withdrawal signs not attributable to other causes. Once this is level of opioid withdrawal is achieved, ≥ 8 mg of sublingual buprenorphine/naloxone (BUP/NLX) will be administered consistent with the recommended minimum induction dose in the product monograph and published high dose induction strategies.
If the patient opts for extended release buprenorphine treatment (BUP-XR) and their COWS score has not increased by more than 5 points one hour after sublingual buprenorphine/naloxone administration, a 300 mg dose of BUP-XR will be administered subcutaneously one hour after their sublingual BUP/NLX.
The following information will the collected
- Substance use history
- Substance use treatment utilization
- Harm reduction service utilization
- Clinical Opiate Withdrawal Scores / Subjective Opiate Withdrawal Scores
- Vital Signs (Heart rate, blood pressure, respiratory rate, oxygen saturation)
- Adverse events
- Treatment satisfaction questionnaire for medication (TSQM)
Following the SINI protocol, participants receiving sublingual BUP/NLX treatment, ongoing medication dispensing will transition to a community pharmacy in accordance with standard clinical practice. Participants receiving subcutaneous BUP/XR treatment, subsequent doses will be administered either at a CPAS physician's office, clinic, or pharmacy, as per standard clinical practice. Participants will be followed for 28 days, during which the information listed below will be collected.
- Retention on BUP/NLX or BUP-XR, or other forms of OAT
- Unregulated opioid use
- Rates of overdose and hospitalization
- Adverse events
- Conditions
- Opioid Use Disorder
- Being tested
- Naloxone Hydrochloride 0.4 MG/ML, Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg), Buprenorphine extended-release injection (300 mg/1.5 mL)
- Keywords
- Opioid Use Disorder, Opioid Agonist Therapy, Buprenorphine, Fentanyl, Naloxone, Medications for Opioid Use Disorder, Buprenorphine Extended-Release
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naloxone Hydrochloride 0.4 MG/MLDrug
0.1 mg naloxone is administered IV every 2 minutes until mild symptoms with COWS ≥ 8 and at least two objective withdrawal signs not attributable to other causes. If fourth and subsequent doses are needed, and withdrawal symptoms are not emerging or are progressing too slowly, the dose may be increased to 0.2 mg based on clinical judgment.
Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg)Drug
Also called Buprenorphine/naloxone, Suboxone
If the patient opts for BUP/NLX treatment, ≥ 2 mg BUP/NX will be administered under the tongue Q1-3H PRN for withdrawal/pain/cravings. The total dose administered on the first day determines the starting dose for Day 2. If symptoms persist on Day 2, extra doses can be given until stable, and that total amount on Day 2 becomes the new maintenance dose (Maximum dose: 32 mg/day).
Buprenorphine extended-release injection (300 mg/1.5 mL)Drug
Also called Sublocade, subcutaneous buprenorphine
If the patient opts for BUP-XR, 1 hour after the administration of sublingual buprenorphine/naloxone, study nurse or physician will subcutaneously administer buprenorphine extended-release injection (300 mg/1.5 mL).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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) Receives: Drug: Naloxone Hydrochloride 0.4 MG/ML; Drug: Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg); Drug: Buprenorphine extended-release injection (300 mg/1.5 mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Number of participants enrolled per month
Measured: Enrollment
Proportion of ≥8 mg BUP/NLX
Proportion of enrolled patients who receive ≥8 mg sublingual buprenorphine/naloxone within 1 hour of protocol initiation
Measured: Within 1 hour of first NLX dose
Proportion of 300 mg BUP-XR
Proportion of enrolled patients who transition to 300 mg Buprenorphine extended release within 1 hour of first BUP/NLX dose, for those who elect it
Measured: Within 1 hour of first BUP/NLX dose
Secondary outcomes (13)
Recruitment
Number of patients approached, eligible, consented
Measured: Through study completion, anticipated to be 6 months
Unregulated opioid use
Opioid use within 24 hours prior to SINI, during the induction, OAT, and follow up
Measured: Baseline, Follow up (Day 14 and 28).
Severity of Opioid Withdrawal (Subjective)
Subjective Opiate Withdrawal Scale (Score range: 1-30) Mild Withdrawal: 1 - 10 , Moderate withdrawal: 11 - 20 , Severe withdrawal: 21 - 30
Measured: Intervention (before, after, and during), and follow up (Day 14 and 28)
Respiratory rate
Respiration rate
Measured: Baseline; 2 minutes after each NLX dose; immediately prior to first BUP/NLX dose; 1 hour and 3 hours after first BUP/NLX dose; immediately prior to 300 mg BUP-XR dose; 1 hour, 12 hours, and 24 hours after 300 mg BUP-XR dose
Heart Rate
Heart rate
Measured: Baseline; 2 minutes after each NLX dose; immediately prior to first BUP/NLX dose; 1 hour and 3 hours after first BUP/NLX dose; immediately prior to 300 mg BUP-XR dose; 1 hour, 12 hours, and 24 hours after 300 mg BUP-XR dose
Oxygen Saturation
Oxygen saturation
Measured: Baseline; 2 minutes after each NLX dose; immediately prior to first BUP/NLX dose; 1 hour and 3 hours after first BUP/NLX dose; immediately prior to 300 mg BUP-XR dose; 1 hour, 12 hours, and 24 hours after 300 mg BUP-XR dose
Blood Pressure
Systolic and Diastolic Blood Pressure
Measured: Baseline; 2 minutes after each NLX dose; immediately prior to first BUP/NLX dose; 1 hour and 3 hours after first BUP/NLX dose; immediately prior to 300 mg BUP-XR dose; 1 hour, 12 hours, and 24 hours after 300 mg BUP-XR dose
Participant reported experience
Treatment Satisfaction Questionnaire for Medication (TSQM).
Measured: Post intervention and follow up (Day 14 and 28)
Adverse Event
Incidence of adverse events (AEs) possibly/probably/definitely related to the study drug
Measured: During intervention and follow up (Day 14 -28)
Severity of Opioid Withdrawal (Objective)
Clinical Opiate Withdrawal Score (Score: 0-40) 0-12: Mild withdrawal, 13-24: Moderate withdrawal, 25-36: Moderately severe withdrawal, and above 36: Severe withdrawal
Measured: Intervention (before, after, and during), and follow up (Day 14 and 28)
Intervention delivery and timing
Dose and timing of each NLX dose, the first BUP/NLX dose, any subsequent BUP/NLX doses prior to 300 mg BUP-XR, and the 300 mg BUP-XR dose (for patients who elect it)
Measured: From first NLX administration through 24 hours after 300 mg BUP-XR administration, or through 3 hours after first BUP/NLX administration for participants not receiving BUP-XR.
OAT retention
Retention of sublingual buprenorphine/naloxone, extended release buprenorphine, and other opioid agonist therapy
Measured: Follow up (Day 14 and 28)
Overdose and Hospitalization
Rate of overdose and hospitalization
Measured: Follow up (Day 14 to Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start29 Apr 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pouya Azar
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver General Hospital, VGH and UBC Hospital Foundation, British Columbia Centre for Excellence in HIV/AIDS
- Responsible party
- Sponsor-investigator, Pouya Azar, University of British Columbia
- Investigators
- Pouya Azar, MD, Principal investigator, Department of Psychiatry, Faculty of Medicine, University of British Columbia and Vancouver General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439549
- Sponsor's protocol ID
- H25-01585
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom-inhibited Naloxone Induction (SINI) to Initiate Buprenorphine/Naloxone and Buprenorphine Extended-release for Opioid Use Disorder: A Single-arm Feasibility Trial
- ClinicalTrials.gov ID
- NCT07439549
- Acronym / sponsor ID
- H25-01585
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid Use Disorder, Opioid Agonist Therapy, Buprenorphine, Fentanyl, Naloxone, Medications for Opioid Use Disorder, Buprenorphine Extended-Release
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Pouya AzarUniversity, hospital or other
- Collaborators
- Vancouver General Hospital, VGH and UBC Hospital Foundation, British Columbia Centre for Excellence in HIV/AIDS
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
This is a prospective, single arm, open label, feasibility study involving 12 participants with opioid use disorder who have a clinical indication to start opioid agonist therapy with buprenorphine. Eligible participants provide informed consent will undergo buprenorphine induction using the symptom inhibited naloxone induction protocol (SINI). A study doctor or nurse will administer 0.1 - 0.2 mg of intravenous naloxone every 2 minutes until the patient is in mild opioid withdrawal, defined as a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 and at least two objective withdrawal signs not attributable to other causes. Once this is level of opioid withdrawal is achieved, ≥ 8 mg of sublingual buprenorphine/naloxone (BUP/NLX) will be administered consistent with the recommended minimum induction dose in the product monograph and published high dose induction strategies.
If the patient opts for extended release buprenorphine treatment (BUP-XR) and their COWS score has not increased by more than 5 points one hour after sublingual buprenorphine/naloxone administration, a 300 mg dose of BUP-XR will be administered subcutaneously one hour after their sublingual BUP/NLX.
The following information will the collected
- Substance use history
- Substance use treatment utilization
- Harm reduction service utilization
- Clinical Opiate Withdrawal Scores / Subjective Opiate Withdrawal Scores
- Vital Signs (Heart rate, blood pressure, respiratory rate, oxygen saturation)
- Adverse events
- Treatment satisfaction questionnaire for medication (TSQM)
Following the SINI protocol, participants receiving sublingual BUP/NLX treatment, ongoing medication dispensing will transition to a community pharmacy in accordance with standard clinical practice. Participants receiving subcutaneous BUP/XR treatment, subsequent doses will be administered either at a CPAS physician's office, clinic, or pharmacy, as per standard clinical practice. Participants will be followed for 28 days, during which the information listed below will be collected.
- Retention on BUP/NLX or BUP-XR, or other forms of OAT
- Unregulated opioid use
- Rates of overdose and hospitalization
- Adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Naloxone Hydrochloride 0.4 MG/ML, Drug: Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg), Drug: Buprenorphine extended-release injection (300 mg/1.5 mL)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) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naloxone Hydrochloride 0.4 MG/ML0.1 mg naloxone is administered IV every 2 minutes until mild symptoms with COWS ≥ 8 and at least two objective withdrawal signs not attributable to other causes. If fourth and subsequent doses are needed, and withdrawal symptoms are not emerging or are progressing too slowly, the dose may be increased to 0.2 mg based on clinical judgment. | Drug | Intervention |
| Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg)Also: Buprenorphine/naloxone, SuboxoneIf the patient opts for BUP/NLX treatment, ≥ 2 mg BUP/NX will be administered under the tongue Q1-3H PRN for withdrawal/pain/cravings. The total dose administered on the first day determines the starting dose for Day 2. If symptoms persist on Day 2, extra doses can be given until stable, and that total amount on Day 2 becomes the new maintenance dose (Maximum dose: 32 mg/day). | Drug | Intervention |
| Buprenorphine extended-release injection (300 mg/1.5 mL)Also: Sublocade, subcutaneous buprenorphineIf the patient opts for BUP-XR, 1 hour after the administration of sublingual buprenorphine/naloxone, study nurse or physician will subcutaneously administer buprenorphine extended-release injection (300 mg/1.5 mL). | Drug | Intervention |
Primary outcome
Enrollment rate
Time frame: Enrollment
Number of participants enrolled per month
Proportion of ≥8 mg BUP/NLX
Time frame: Within 1 hour of first NLX dose
Proportion of enrolled patients who receive ≥8 mg sublingual buprenorphine/naloxone within 1 hour of protocol initiation
Proportion of 300 mg BUP-XR
Time frame: Within 1 hour of first BUP/NLX dose
Proportion of enrolled patients who transition to 300 mg Buprenorphine extended release within 1 hour of first BUP/NLX dose, for those who elect it
13 secondary outcomes
Recruitment
Time frame: Through study completion, anticipated to be 6 months
Unregulated opioid use
Time frame: Baseline, Follow up (Day 14 and 28).
Severity of Opioid Withdrawal (Subjective)
Time frame: Intervention (before, after, and during), and follow up (Day 14 and 28)
Respiratory rate
Time frame: Baseline; 2 minutes after each NLX dose; immediately prior to first BUP/NLX dose; 1 hour and 3 hours after first BUP/NLX dose; immediately prior to 300 mg BUP-XR dose; 1 hour, 12 hours, and 24 hours after 300 mg BUP-XR dose
Heart Rate
Time frame: Baseline; 2 minutes after each NLX dose; immediately prior to first BUP/NLX dose; 1 hour and 3 hours after first BUP/NLX dose; immediately prior to 300 mg BUP-XR dose; 1 hour, 12 hours, and 24 hours after 300 mg BUP-XR dose
Oxygen Saturation
Time frame: Baseline; 2 minutes after each NLX dose; immediately prior to first BUP/NLX dose; 1 hour and 3 hours after first BUP/NLX dose; immediately prior to 300 mg BUP-XR dose; 1 hour, 12 hours, and 24 hours after 300 mg BUP-XR dose
Blood Pressure
Time frame: Baseline; 2 minutes after each NLX dose; immediately prior to first BUP/NLX dose; 1 hour and 3 hours after first BUP/NLX dose; immediately prior to 300 mg BUP-XR dose; 1 hour, 12 hours, and 24 hours after 300 mg BUP-XR dose
Participant reported experience
Time frame: Post intervention and follow up (Day 14 and 28)
Adverse Event
Time frame: During intervention and follow up (Day 14 -28)
Severity of Opioid Withdrawal (Objective)
Time frame: Intervention (before, after, and during), and follow up (Day 14 and 28)
Intervention delivery and timing
Time frame: From first NLX administration through 24 hours after 300 mg BUP-XR administration, or through 3 hours after first BUP/NLX administration for participants not receiving BUP-XR.
OAT retention
Time frame: Follow up (Day 14 and 28)
Overdose and Hospitalization
Time frame: Follow up (Day 14 to Day 28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pouya Azar, MD principal investigator
Department of Psychiatry, Faculty of Medicine, University of British Columbia and Vancouver General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naloxone Hydrochloride 0.4 MG/ML, Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg) and Buprenorphine extended-release injection (300 mg/1.5 mL) in people with Opioid Use Disorder, run by Pouya Azar at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Wong, MSc ((604) 875-5823, james.wong@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: Enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.