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Extended-Release 7-Day Injectable Buprenorphine for Patients With Minimal to Mild Opioid Withdrawal.
Gail D'Onofrio1,2,3, Andrew A Herring4,5,6, Jeanmarie Perrone7
1Department of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut.
JAMA Network Open
|July 8, 2024
Summary
A new 7-day injectable buprenorphine formulation is safe and well-tolerated for opioid use disorder (OUD) patients with minimal to mild withdrawal. This extended-release option could improve OUD treatment accessibility and adherence.
Area of Science:
- Pharmacology
- Addiction Medicine
- Clinical Trials
Background:
- Buprenorphine is an effective treatment for opioid use disorder (OUD), but its underutilization remains a challenge.
- Extended-release formulations offer potential advantages in improving treatment adherence and accessibility.
Purpose of the Study:
- To assess the feasibility, including acceptability, tolerability, and safety, of a 7-day injectable extended-release buprenorphine in patients experiencing minimal to mild opioid withdrawal.
- To evaluate patient-reported outcomes such as injection pain, satisfaction, and craving.
Main Methods:
- A nonrandomized trial involving 100 adult patients with moderate to severe OUD and low Clinical Opiate Withdrawal Scale (COWS) scores (0-7) across four US emergency departments.
- Patients received a single 24-mg dose of weekly extended-release buprenorphine, with assessments conducted daily via telephone and in person at 7 days.
Main Results:
- The injectable formulation was found to be acceptable and well-tolerated, with low rates of significant withdrawal increase (10%) or precipitated withdrawal (2% within 1 hour, 7% within 4 hours).
- Injection site pain was minimal. High patient satisfaction was noted, with many reporting no cravings or opioid use. 73% were engaged in OUD treatment at 7 days.
Conclusions:
- The 7-day injectable extended-release buprenorphine is a feasible, safe, and well-tolerated option for patients with minimal to mild opioid withdrawal (COWS 4-7).
- This novel formulation has the potential to significantly expand access to buprenorphine treatment for individuals with OUD.
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