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Rapid vs Standard Induction to Injectable Extended-Release Buprenorphine: A Randomized Clinical Trial.

Rajinder Shiwach¹, Bernard Le Foll², Hannu Alho³

¹InSite Clinical Research, Desoto, Texas.

JAMA Network Open

|October 14, 2025

Summary

This summary is machine-generated.

Rapid induction (RI) of buprenorphine-naloxone showed higher retention rates than standard induction (SI) for opioid use disorder treatment. This approach is effective, especially for patients using fentanyl, and is well-tolerated.

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Area of Science:

Addiction Medicine
Pharmacology
Clinical Trials

Background:

Standard induction (SI) of transmucosal buprenorphine-naloxone presents challenges for individuals with high-dose, injected, or synthetic opioid use.
Opioid use disorder (OUD) treatment requires effective induction methods for diverse patient populations.

Purpose of the Study:

To compare the effectiveness and safety of rapid induction (RI) versus SI followed by extended-release buprenorphine injection.
To evaluate retention rates and adverse events in OUD patients undergoing different induction protocols.

Main Methods:

A multicenter, open-label, randomized clinical trial involving 729 participants with moderate to severe OUD.
Participants were randomized to RI (single 4-mg dose) or SI (≥7 days) before receiving extended-release buprenorphine injections.
Primary endpoint was retention rate at the second injection, analyzed using a Bayesian approach. Subgroup analyses included fentanyl use.

Main Results:

RI demonstrated noninferiority with higher retention than SI at the second injection (11.8% difference).
Among participants testing positive for fentanyl, RI showed a 14.8% higher retention rate.
Adverse event incidence was similar between RI and SI groups, with most events related to opioid withdrawal.

Conclusions:

Rapid induction (RI) of buprenrenorphine-naloxone offers superior retention compared to standard induction (SI) for extended-release buprenorphine treatment in OUD.
RI is particularly beneficial for patients using fentanyl and is well-tolerated.
Administering the second injection after one week optimizes therapeutic levels and patient retention.