[Translation] A randomized, double-blind, parallel, placebo-controlled clinical trial to evaluate the efficacy and safety of tetrodoxin for injection in the treatment of acute heroin withdrawal syndrome
以安慰剂为对照,评价注射用替曲朵辛(20μg)治疗海洛因依赖急性戒断综合征的有效性和安全性,确定最佳的治疗剂量,受益/危害比率,为设计IIb期与III期临床试验确定给药剂量方案提供依据。
[Translation] To evaluate the efficacy and safety of tetrodotoxin injection (20 μg) in the treatment of acute withdrawal syndrome of heroin dependence, using placebo as a control, determine the optimal therapeutic dose and benefit/harm ratio, and provide a basis for designing the dosing regimen for Phase IIb and Phase III clinical trials.