NCT07433413

Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use Disorder

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of Naltrexone Hydrochloride Implant for the Treatment of Alcohol Use Disorder

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Shenzhen Sciencare Medical Industries Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. The study plans to enroll 240 adult patients with Alcohol Use Disorder (AUD). After providing written informed consent and undergoing screening for eligibility criteria, eligible subjects will be randomized in a 2:1 ratio to receive treatment in either the experimental group (1.5 g Naltrexone Hydrochloride Implant plus non-specific supportive psychotherapy) or the control group (placebo implant plus non-specific supportive psychotherapy). On Day 1, subjects will receive a single subcutaneous implantation via a small abdominal incision, receiving either the Naltrexone Hydrochloride Implant or the placebo implant. Following implantation, subjects will be hospitalized for at least 2 hours (the investigator may extend this observation period up to 3 days based on the patient's condition). Subjects will change the wound dressing by themselves on postoperative Day 3. Efficacy and safety assessments will continue through Week 24 post-randomization/dosing, involving a total of 11 visits. Among these, Visit 5 (Week 3) will be conducted via telephone, while all other visits will be performed as outpatient clinic visits.

Conditions

• Alcohol Use Disorder (AUD)

Interventions

Type	Name	Description
DRUG	Naltrexone	Dosage Form: Implant Specification: 150 mg/Tablet Dosage and Administration: Subcutaneous implantation of 10 tablets (1500 mg) Duration of Treatment: Single administration
DRUG	placebo	Dosage Form: Implant Specification: 150 mg/Tablet Dosage and Administration: Subcutaneous implantation of 10 tablets (1500 mg) Duration of Treatment: Single administration

Timeline

• Start date: 2026-03-15
• Primary completion: 2027-04-01
• Completion: 2027-05-01
• First posted: 2026-02-25
• Last updated: 2026-02-25