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

NCT07333638 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-01-12

No results posted yet for this study

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

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)

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-03
Primary Completion
2024-09-27
Completion
2024-10-10

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 NCT07333638 on ClinicalTrials.gov