Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial
Symptom-inhibited Naloxone Induction (SINI) to Initiate Buprenorphine/Naloxone and Buprenorphine Extended-release for Opioid Use Disorder: A Single-arm Feasibility Trial
Pouya Azar
12 participants
Apr 29, 2026
INTERVENTIONAL
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?
Eligibility
Inclusion Criteria8
- 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 Criteria9
- 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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Interventions
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.
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).
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).
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07439549