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?
⁃ 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.