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

NCT07014644 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-06-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shenzhen Sciencare Medical Industries Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2020-05-13
Completion
2020-05-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07014644 on ClinicalTrials.gov