Open-label, rapid initiation pilot study for extended-release buprenorphine subcutaneous injection

Area of Science:

• Pharmacology
• Addiction Medicine
• Clinical Trials

Background:

• Buprenorphine extended-release injection (BUP-XR) offers sustained therapeutic concentrations for opioid use disorder (OUD).
• Transmucosal buprenorphine (BUP-TM) induction can present retention challenges.
• Efficient initiation strategies for BUP-XR are crucial for patient outcomes.

Purpose of the Study:

• To evaluate the safety and tolerability of initiating BUP-XR after a single 4 mg dose of BUP-TM.
• To assess withdrawal symptom management during this induction method.

Main Methods:

• An open-label, single-center pilot study involving participants with OUD.
• Administration of a single 4 mg BUP-TM dose if Clinical Opiate Withdrawal Scale (COWS) score was ≥8.
• Initiation of BUP-XR 300 mg in participants without hypersensitivity, precipitated opioid withdrawal (POW), or sedation.

Main Results:

• Twenty-four participants received BUP-XR; 20 completed the study.
• COWS scores significantly decreased from a baseline of 14.6 to 4.2 within 24 hours post-BUP-TM.
• Two participants experienced POW, and mild adverse events like irritability and nausea were reported; no serious AEs occurred.

Conclusions:

• Initiating BUP-XR 300 mg following a single BUP-TM 4 mg dose is well-tolerated and safe.
• This flexible initiation strategy effectively manages withdrawal symptoms.
• The findings support adapting BUP-XR initiation protocols for improved patient retention and outcomes.