Among adults with opioid dependence maintaining abstinence with a stable dose of sublingual buprenorphine, the use of buprenorphine implants, compared with continued sublingual buprenorphine, did not result in an inferior likelihood of remaining a responder, according to a study published in the July 19 issue of JAMA.
Opioid dependence is a growing public health concern in the United States. The effectiveness of treatment with the medication buprenorphine is limited by suboptimal adherence.
Richard N. Rosenthal, MD, Icahn School of Medicine at Mount Sinai, New York, New York, and colleagues examined if 6-month subdermal buprenorphine implants maintained low to no illicit opioid use relative to daily sublingual buprenorphine among currently stable opioid-dependent patients receiving buprenorphine maintenance treatment.
For the study, 177 opioid-dependent patients with stable abstinence were randomised to sublingual buprenorphine with placebo implants (n = 90) or buprenorphine implants with sublingual placebo (n = 87); 165 of 177 patients (93 percent) completed the trial.
Of the 84 patients receiving buprenorphine implants, 81 (96%) were responders (≥ 4 of 6 months without opioid-positive urine test result [monthly and 4 times randomly] and self-report), compared with 78 of 89 (88%) of patients receiving sublingual buprenorphine.
Over 6 months, 72 of 84 (86%) receiving buprenorphine implants and 64 of 89 (72%) receiving sublingual buprenorphine maintained opioid abstinence.
Non-implant-related and implant-related adverse events occurred in 48% and 23% of the buprenorphine implant group and in 53% and 13.5% of participants in the sublingual buprenorphine group, respectively.
“Buprenorphine is an effective treatment for opioid dependence; however, adherence to daily dosing for management of chronic disorders is challenging,” the authors wrote. “An implantable buprenorphine delivery system reduces adherence issues and may improve efficacy.”
In an accompanying editorial, Wilson M. Compton, MD, and Nora D. Volkow, MD, National Institute on Drug Abuse, part of the National Institutes of Health (NIH), Bethesda, Maryland, 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. However, buprenorphine implants are currently approved by the US Food and Drug Administration for only up to 1 year of treatment for a subgroup of patients who have already achieved and sustained prolonged clinical stability while receiving low to moderate doses of oral transmucosal buprenorphine, a caveat clearly stated in the product label. Even so, this novel approach to delivering care may open up treatment for new, previously difficult-to-reach populations or for those in the criminal justice system. Although further research is needed to determine which populations would benefit the most from these new formulations, the potential of these agents to have a positive role in the current opioid crisis is undeniable.”