NCT07014644

A Randomized, Double-Blind, Single-Center Clinical Study on the Efficacy of Naltrexone Implant in Antagonizing Opioid Agonist Hydromorphone

A Randomized, Double-blind, Single-center Clinical Study to Evaluate the Efficacy and Safetyof Naltrexone Implant in Antagonizing Opioid Agonist Hydromorphone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Shenzhen Sciencare Medical Industries Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Opioid Dependence

Interventions

Type	Name	Description
DRUG	0.9g Naltrexone Implant + 0.6g Naltrexone Implant Placebo	0.9g Naltrexone Implant + 0.6g Naltrexone Implant Placebo
DRUG	1.5g Naltrexone Implant	1.5g Naltrexone Implant

Timeline

• Start date: 2018-08-07
• Primary completion: 2020-05-13
• Completion: 2020-05-19
• First posted: 2025-06-11
• Last updated: 2025-06-11

Locations

1 site across 1 country: China