Using an implant device to administer buprenorphine for adult patients being treated for opioid addiction is a viable alternative to the standard sublingual buprenorphine, a randomized clinical trial published online July 19 suggests.
“An implantable buprenorphine delivery system reduces adherence issues and may improve efficacy,” wrote Richard N. Rosenthal, MD, of the Icahn School of Medicine at Mount Sinai, New York, and his coinvestigators. “Furthermore, buprenorphine implants may reduce the need for sublingual buprenorphine, decreasing its availability for diversion, misuse, and harms.”
Courtesy Braeburn Pharmaceuticals
Dr. Rosenthal and his coinvestigators enrolled 177 patients from June 2014 to May 2015. The participants were aged 18-65 years, had received a primary diagnosis of opioid addiction, and had been receiving daily 8-mg doses of sublingual buprenorphine at an outpatient clinic for at least 24 weeks. The average age of patients was 39 years, and 40.9% were female. All of the participants were recruited from 21 treatment sites across the United States (JAMA. 2016;316[3]:282-90).
The participants were randomized into one of two cohorts: 87 subjects received buprenorphine implants, and the remaining 90 received sublingual buprenorphine. Those in the former cohort received their implants on the day of randomization, with four subdermal devices implanted along the inner upper arm. The staff involved with implanting and removing the devices did not have anything to do with study evaluation, in order to maintain blinding. Ten urine samples were collected from subjects over the course of the study period, with follow-up visits at 1 week and 2 weeks post treatment.
“The primary efficacy endpoint was the difference in proportion of responders, defined as participants with at least 4 of 6 months without evidence of illicit opioid use (based on urine test and self-report composites) by treatment group” the authors clarified.
Ultimately, 84 of those who received implants and 89 of those receiving sublingual treatment completed the trial, and were included in the primary analysis. Of those, 81 of those receiving implants (96.4%) and 78 of those receiving sublingual buprenorphine (87.6%) responded to treatment.
Based on urine tests and self-reporting, 72 of those with implants (85.7%) maintained their opioid abstinence throughout the study period, compared with 64 of those in the sublingual treatment cohort (71.9%). Additionally, Dr. Rosenthal and his coinvestigators noted that sustained abstinence in months 3-6 was more prominent in the implant cohort. Adverse events not related to the implant site occurred in 42 of the implant subjects (48.3%) and 47 of the sublingual treatment subjects (52.8%).
“To our knowledge, this was the first comparative trial to evaluate efficacy and safety of 6-month buprenorphine implants relative to sublingual buprenorphine in this understudied population of patients clinically stable taking sublingual buprenorphine,” the authors stated. They added that “because there are limited data on patients stable on sublingual buprenorphine, it is important to study maintenance and improvement of stability in patients who achieve good clinical response to initial buprenorphine treatment” with regard to further study.
Dr. Rosenthal and his coinvestigators disclosed receiving grants and nonfinancial support from Braeburn Pharmaceuticals, which was the sole provider of funding for this study. The other investigators also reported financial relationships with other companies.