Trial reportJournal of addiction medicine
A Long-acting Naltrexone Implant (iSTEP-N) for Opioid Use Disorder: First-in-Human Phase I Trial.
Trial report in Journal of addiction medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
7 authors.
Funding
Abstract
objectivesiSTEP-N is a novel, bioresorbable, subcutaneous implant designed to release naltrexone for 6-12 months after a single procedure and improve adherence. This first-in-human study evaluated the safety and pharmacokinetics of iSTEP-N.
methodsThis was a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose trial. Sixteen healthy adults (10 females and 6 males) were assigned to receive either 1 implant (4.8 g naltrexone), 2 implants (9.6 g naltrexone), or placebo implants. Participants were followed for 12 weeks, after which implants were removed per regulatory requirement. Plasma naltrexone concentrations and safety outcomes were assessed throughout.
resultsAll participants completed the study. The 9.6 g cohort maintained mean plasma naltrexone concentrations above the 2.0 ng/mL opioid blockade threshold from Tmax at 10 hours through the end of the study at 12 weeks; no mean value fell below 2.8 ng/mL during this time. The 4.8 g cohort maintained therapeutic levels of naltrexone through week 6 but dropped below threshold thereafter. In both cohorts, ∼22% of implant drug content was released over 12 weeks, based on plasma exposure and estimated clearance, indicating potential for extended coverage. In the 9.6 g group, seroma formation was observed in 3 of 6 participants (50%) and resolved without intervention. No serious adverse events occurred.
conclusionsAt the 9.6 g dose, iSTEP-N provided sustained therapeutic naltrexone exposure for 12 weeks with a favorable safety profile, while releasing less than one-fourth of its drug content. Further studies will evaluate longer-term exposure, safety, and clinical feasibility in individuals with opioid use disorder.
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