Recruiting

SINI with Buprenorphine

Sponsor:

Pouya Azar

Code:

NCT07439549

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

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)

Study Details

Brief 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. 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?

Conditions

Opioid Use Disorder

Study ID

NCT07439549

Start date

Apr 29, 2026

Status verified date

Apr, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

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)

Interventions

Naloxone Hydrochloride 0.4 MG/ML

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)

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)

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).

Primary outcome measure

  • Enrollment rate [ Time Frame: Enrollment ]
  • Proportion of ≥8 mg BUP/NLX [ Time Frame: Within 1 hour of first NLX dose ]
  • Proportion of 300 mg BUP-XR [ Time Frame: Within 1 hour of first BUP/NLX dose ]

Central Contacts and Locations

Central contacts

James Wong, MSc

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

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada

Contacts

James Wong, MSc

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

Principal Investigator:

Pouya Azar, MD

More Information

Sponsor

Pouya Azar

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Opioid Use Disorder
  • Opioid Agonist Therapy
  • Buprenorphine
  • Fentanyl
  • Naloxone
  • Medications for Opioid Use Disorder
  • Buprenorphine Extended-Release

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pouya Azar on 2026-05-01.