[Translation] A randomized, double-blind, single-center clinical study of the efficacy of naltrexone implants against the opioid agonist hydromorphone
主要目的:在阿片类物质成瘾患者康复期受试者中,研究纳曲酮植入剂拮抗阿片类物质的有效性及安全性,评价有效拮抗剂量,为Ⅲ期临床试验方案设计提供参考。 次要目的:研究纳曲酮植入剂及氢吗啡酮在受试者体内的药代动力学。
[Translation] Main purpose: To study the efficacy and safety of naltrexone implants in antagonizing opioids in opioid-addicted subjects in the rehabilitation period, to evaluate the effective antagonist dose, and to provide reference for the design of phase III clinical trials. Secondary objective: To study the pharmacokinetics of naltrexone implants and hydromorphone in subjects.