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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.”
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.
“Because of the overall high prevalence and marked increases in morbidity and mortality associated with nonmedical prescription opioids and heroin, addressing opioid use disorders is a public health priority in the United States,” wrote Wilson M. Compton, MD, and Nora D. Volkow, MD, in an accompanying editorial (JAMA. 2016;316[3]:277-79).
But a fundamental challenge in addressing the treatment of chronic diseases such as opioid use disorder is nonadherence and discontinuation of care, they wrote. The use of extended-release formulations has been one approach. For example, extended-release naltrexone is administered monthly rather than the “nearly daily dosing necessary for the oral formulations of naltrexone, methadone, and buprenorphine. An additional concern for the agonist medications used for opioid use disorders is their risk of being diverted and misused.”
The results of the study by Richard N. Rosenthal, MD, and his colleagues show clearly that buprenorphine implants are not inferior to buprenorphine administered sublingually. However, as the study authors pointed out, several factors limit the generalizability of their results. For example, the patient population in their study were primarily white, employed, had at least a high school education, and were prescription opioid dependent.
“The approval of this new buprenorphine implant formulation provides a unique new tool to address the complex, often chronic and relapsing opioid use disorders,” Dr. Compton and Dr. Volkow wrote. “This novel implant system may help buttress patients’ decision-making deficits that are a core component of the addiction by making these lifesaving medication adherence decisions far more infrequent.”
Dr. Compton, deputy director of the National Institute on Drug Abuse, reported owning stock in Pfizer, General Electric, and 3M. Dr. Volkow is director of NIDA and reported no disclosures.
“Because of the overall high prevalence and marked increases in morbidity and mortality associated with nonmedical prescription opioids and heroin, addressing opioid use disorders is a public health priority in the United States,” wrote Wilson M. Compton, MD, and Nora D. Volkow, MD, in an accompanying editorial (JAMA. 2016;316[3]:277-79).
But a fundamental challenge in addressing the treatment of chronic diseases such as opioid use disorder is nonadherence and discontinuation of care, they wrote. The use of extended-release formulations has been one approach. For example, extended-release naltrexone is administered monthly rather than the “nearly daily dosing necessary for the oral formulations of naltrexone, methadone, and buprenorphine. An additional concern for the agonist medications used for opioid use disorders is their risk of being diverted and misused.”
The results of the study by Richard N. Rosenthal, MD, and his colleagues show clearly that buprenorphine implants are not inferior to buprenorphine administered sublingually. However, as the study authors pointed out, several factors limit the generalizability of their results. For example, the patient population in their study were primarily white, employed, had at least a high school education, and were prescription opioid dependent.
“The approval of this new buprenorphine implant formulation provides a unique new tool to address the complex, often chronic and relapsing opioid use disorders,” Dr. Compton and Dr. Volkow wrote. “This novel implant system may help buttress patients’ decision-making deficits that are a core component of the addiction by making these lifesaving medication adherence decisions far more infrequent.”
Dr. Compton, deputy director of the National Institute on Drug Abuse, reported owning stock in Pfizer, General Electric, and 3M. Dr. Volkow is director of NIDA and reported no disclosures.
“Because of the overall high prevalence and marked increases in morbidity and mortality associated with nonmedical prescription opioids and heroin, addressing opioid use disorders is a public health priority in the United States,” wrote Wilson M. Compton, MD, and Nora D. Volkow, MD, in an accompanying editorial (JAMA. 2016;316[3]:277-79).
But a fundamental challenge in addressing the treatment of chronic diseases such as opioid use disorder is nonadherence and discontinuation of care, they wrote. The use of extended-release formulations has been one approach. For example, extended-release naltrexone is administered monthly rather than the “nearly daily dosing necessary for the oral formulations of naltrexone, methadone, and buprenorphine. An additional concern for the agonist medications used for opioid use disorders is their risk of being diverted and misused.”
The results of the study by Richard N. Rosenthal, MD, and his colleagues show clearly that buprenorphine implants are not inferior to buprenorphine administered sublingually. However, as the study authors pointed out, several factors limit the generalizability of their results. For example, the patient population in their study were primarily white, employed, had at least a high school education, and were prescription opioid dependent.
“The approval of this new buprenorphine implant formulation provides a unique new tool to address the complex, often chronic and relapsing opioid use disorders,” Dr. Compton and Dr. Volkow wrote. “This novel implant system may help buttress patients’ decision-making deficits that are a core component of the addiction by making these lifesaving medication adherence decisions far more infrequent.”
Dr. Compton, deputy director of the National Institute on Drug Abuse, reported owning stock in Pfizer, General Electric, and 3M. Dr. Volkow is director of NIDA and reported no disclosures.
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.”
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.
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.”
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.
FROM JAMA
Key clinical point: Buprenorphine implants are no less effective than sublingual buprenorphine, the current standard of care, in managing opioid dependence.
Major finding: 96.4% of those with implants and 87.6% of those with sublingual buprenorphine responded to treatment; over 6 months, 85.7% of those with implants and 71.9% of those receiving sublingual treatment maintained opioid resistance.
Data source: An outpatient, randomized, active-controlled, 24-week, double-blind, double-dummy study of 177 buprenorphine patients at 21 U.S. sites.
Disclosures: The study funded by Braeburn Pharmaceuticals. Dr. Rosenthal and other coinvestigators disclosed receiving grants and nonfinancial support from Braeburn Pharmaceuticals while this study was being conducted. The other investigators also reported financial relationships with other companies.
