NCT07333638

Phase II Clinical Study on the Efficacy and Safety of Naltrexone Implant in Patients With Alcohol Use Disorder

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Different Doses of Naltrexone Implant in Patients With Alcohol Use Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Shenzhen Sciencare Medical Industries Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial. The study plans to enroll 210 adult patients with alcohol use disorder. After signing the informed consent form and undergoing screening based on inclusion/exclusion criteria, eligible participants will be randomly assigned to the low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling), high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling), and control group (placebo + general supportive psychological counseling) in a 1:1:1 ratio. On Day 0, participants will receive a single subcutaneous abdominal incision implantation with either 0.9 g or 1.5 g of naltrexone implant or placebo. Efficacy assessment will follow up to 24 weeks after randomization/dosing, while safety assessment will follow up to 48 weeks. There will be a total of 13 follow-up visits. Except for Day 3 (Visit 3) and Week 36 (Visit 12), which are telephone follow-ups, all other visits will be outpatient follow-ups. The first 24 weeks of the study will be double-blind. After completing the Week 24 follow-up, all participants will undergo efficacy assessment. Then they will enter the open-label observation period, followed up until Week 48.

Conditions

• AUD

Interventions

Type	Name	Description
DRUG	low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling)	low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling)
DRUG	high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling)	high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling)
OTHER	control group (placebo + general supportive psychological counseling)	control group (placebo + general supportive psychological counseling)

Timeline

• Start date: 2023-04-03
• Primary completion: 2024-09-27
• Completion: 2024-10-10
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: China