Study of a New Naloxone-Facilitated Buprenorphine Induction Method for People Using Fentanyl with Opioid Use Disorder

What this Trial Is About

The opioid overdose crisis has been worsened by fentanyl mixing into illicit opioids, complicating treatment with medications for opioid use disorder (MOUD). This research evaluates a new method of starting buprenorphine treatment in people who use fentanyl, aiming to reduce the discomfort and delays often seen with current induction approaches. The study focuses on safely and quickly transitioning patients to buprenorphine by using naloxone first to help avoid prolonged withdrawal symptoms. Participants will receive nasal naloxone followed by a single dose of buprenorphine in a stepwise dose increase from 4 mg up to 24 mg among small groups of participants. This takes place during a 2-3 day residential stay at Johns Hopkins Bayview Medical Campus. Withdrawal symptoms will be closely monitored before and after naloxone and buprenorphine administration. If participants tolerate the initial dose without precipitated withdrawal, additional buprenorphine doses will be given until stabilization is reached. Participants remain overnight for observation and are discharged on day 3 with a short supply of buprenorphine and a connection to ongoing care. During the stay, frequent assessments of withdrawal, craving, and anxiety will be conducted using clinical scales. The study measures peak opioid withdrawal after the first buprenorphine dose, participant acceptance of the treatment over three days, and the time taken to reach a therapeutic dose of 8 mg buprenorphine. Safety and tolerability are monitored throughout, with participants receiving careful medical supervision and follow-up in outpatient treatment after discharge.

Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl