💬In plain words
What the trial is, and whether it could suit you
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?
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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