(27) Real-world Evaluation of an Injectable Extended-Release Buprenorphine Program

Background: The opioid epidemic in the U.S. remains a major public health crisis (1). Yet, 80% of patients are not receiving evidence-based medications for opioid use disorder (OUD) (2,3). In 2017, the Food and Drug Administration approved the first subcutaneous injectable monthly extended-release buprenorphine (XR-BUP) formulation. XR-BUP can address several systemic and individual barriers to consistent buprenorphine treatment. Real-world evaluations of XR-BUP in the outpatient addiction treatment setting are limited. In 2018, Cooper University Health Care’s Center for Healing in Camden, New Jersey integrated an XR-BUP program within its outpatient specialty clinic. The purpose of this study was to characterize the population that received XR-BUP and evaluate 6-month treatment outcomes.

Methods: We retrospectively evaluated adult patients with OUD who were prescribed XR-BUP between 12/1/2018 and 12/31/2020. Manual chart review was used to extract variables from the electronic medical record, including demographics; substance use history; sublingual (SL) buprenorphine and XR-BUP order and administration history; and 6-month treatment outcomes. Chi-square tests were used to compare outcomes between those who received ≥1 XR-BUP injections versus those who did not.

Results: Of the 200 patients prescribed XR-BUP, the mean age was 38 years (SD 10.1), approximately 63% were male who identified as non-Hispanic white, and 92% were insured by Medicaid. Over 88% of patients primarily used heroin/fentanyl; nearly two-thirds reported intravenous use. Sixty patients (30.0%) had ≥1 co-substance use disorder. Of those prescribed XR-BUP, 108 patients (54.0%) received ≥1 injection; the average number of injections received during the 6-month study period was 3.8 (SD 2.05). Six patients (5.9%) were on SL buprenorphine for < 7 days prior to XR-BUP initiation. The average lag time between XR-BUP prescribing and receipt of the first dose was approximately 35 days (SD 25.3). Patients were prescribed an average SL buprenorphine dose of 20 mg (SD 5.19) prior to XR-BUP and 60.2% required supplemental SL buprenorphine for varying time periods. Of the patients who received more than two 300 mg XR-BUP induction doses (n=66), 70% remained on a maintenance dose of 300 mg. Nine patients (8.3%) experienced an XR-BUP adverse event, with injection site reactions being most common. Of those who initiated XR-BUP, 47.2% remained on it at study end. In the overall population at 6 months, 111 patients (55.5%) were still in treatment - 69.4% of those who received ≥1 XR-BUP dose compared to 30.6% of patients who did not initiate XR-BUP (p < 0.001). There were no statistically significant differences in reasons for treatment disengagement at 6 months between the two groups.

Conclusion: To our knowledge, this study represents the largest real-world evaluation of XR-BUP use in an underserved population receiving treatment at an Addiction Medicine outpatient specialty clinic. We found that a larger proportion of XR-BUP-treated patients were still in treatment at 6 months. Future research should evaluate urine toxicology and health care utilization outcomes associated with XR-BUP in a real-world treatment setting.

References: Substance Abuse and Mental Health Services Administration. (2020). Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/
National Academies of Sciences, Engineering, and Medicine (2019). Guideline Report. Medications for Opioid Use Disorder Save Lives. Available at: https://www.nap.edu/catalog/25310/medications-for-opioid-use-disorder-save-lives.
Saloner B, Karthikeyan S. Changes in substance abuse treatment use among individuals with opioid use disorders in the United States, 2004-2013. JAMA 2015;314:1515-1517.