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

NCT07433413 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-02-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shenzhen Sciencare Medical Industries Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2027-04-01
Completion
2027-05-01

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Drugs

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 NCT07433413 on ClinicalTrials.gov