Shenzhen Sciencare Medical Industries Co., Ltd.

Study Design This study is related to a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of different doses of naltrexone implants in the treatment of patients with alcohol use disorders (protocol No.: SK2007-NQT-201, hereinafter referred to as II). This study plans to include 60 patients who are interested in participating in this study in Phase II patients, collect PK blood samples from patients, and conduct PK characteristic analysis. The collected plasma samples will be temporarily stored in a -80 ℃ refrigerator and tested after unblinding in Phase II.

1.主要目的 评价纳曲酮植入剂治疗酒精使用障碍患者的有效性，并进行剂量探索。 2.次要目的 评估纳曲酮植入剂治疗酒精使用障碍患者的安全性。 3.探索性目的 探索纳曲酮植入剂对酒精使用障碍相关的生物学标志物的影响。

This study adopted a randomized, double-blind study design to evaluate the antagonistic effect, safety and pharmacokinetics of Naltrexone (opioid receptor antagonist) implantation after Hydromorphone (opioid receptor agonist) challenge.By using the method of multiple Hydromorphone challenge tests and assessing the clinical symptoms and signs related to opioid agonism as well as the pharmacokinetic parameters of Naltrexone and Hydromorphone, this study aimed to investigate the antagonistic effect of different doses of Naltrexone Implants post dosing in different time periods on different doses of Hydromorphone, to understand the ability of Naltrexone to antagonize Hydromorphone and its effective blood concentration, and to explore the effective dose and duration of Naltrexone Implants in antagonizing Hydromorphone. The study also aimed to provide a basis for the clinical use of Naltrexone Implants in the anti-relapse treatment of opioid dependence, and to provide a reference for the design of Phase 3 clinical studies.