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

NCT07433413 | Not Yet Recruiting Phase 3

• 1 other identifier: SK2007-NQT-301
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Proportion of Heavy Drinking Days During the 24-Week Observation Period Post-Randomization/Post-Dosing

  Specifically, this is calculated as the number of heavy drinking days divided by the number of days at risk for heavy drinking, with the aforementioned days counted up to the date of discontinuation of efficacy observation. "Days at risk for heavy drinking" are defined as the number of days a subject is under efficacy observation starting from the date of hospital discharge following implant administration. Drinking rates are assessed based on the Timeline Follow-Back (TLFB) method, utilizing the daily drinking record form (Appendix 11) completed by the subject and their family members. Heavy drinking is defined as consumption of ≥5 standard drinks per day for males and ≥4 standard drinks per day for females.

  24-Week

Secondary Outcomes (11)

• Reduction of ≥2 levels in WHO alcohol risk grading

  24-week

• Alcohol Consumption (Total Amount Consumed Over 24 Weeks)

  24-week

• Percentage of Days Abstinent (PDA)

  24-week

• Longest Continuous Abstinence Duration

  24-week

• Proportion of Participants Without Heavy Drinking During the Study Observation Period

  24-week

Study Arms (2)

Experimental Group

EXPERIMENTAL

Subjects in the experimental group will receive the 1.5 g Naltrexone Hydrochloride Implant plus non-specific supportive psychotherapy.

Drug: Naltrexone

Control Group

PLACEBO COMPARATOR

Placebo Implant plus non-specific supportive psychotherapy

Drug: placebo

Interventions

Naltrexone DRUG

Dosage Form: Implant Specification: 150 mg/Tablet Dosage and Administration: Subcutaneous implantation of 10 tablets (1500 mg) Duration of Treatment: Single administration

Experimental Group

placebo DRUG

Dosage Form: Implant Specification: 150 mg/Tablet Dosage and Administration: Subcutaneous implantation of 10 tablets (1500 mg) Duration of Treatment: Single administration

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of moderate to severe Alcohol Use Disorder (AUD) based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (meeting four or more diagnostic criteria; refer to Appendix 1 for details).

You may not qualify if:

• Pregnant, breastfeeding, or pregnant with a positive pregnancy test at screening. This includes women of childbearing potential planning to become pregnant during the study.
• Note: Women of childbearing potential are defined as those who are biologically capable of becoming pregnant. To be considered not of childbearing potential, a female subject must meet one of the following: 1) Have had a hysterectomy or bilateral oophorectomy; or 2) Be post-menopausal, defined as having no menses for more than 12 consecutive months.
• Significant abnormality in liver function (e.g., AST or ALT \> 3 times the upper limit of normal), liver failure (e.g., presence of ascites, jaundice, coagulopathy, hepatorenal syndrome, or hepatic encephalopathy), or liver/gallbladder ultrasound findings that may significantly impact the assessment of the investigational drug's efficacy and safety.
• History of severe pancreatitis or severe delirium tremens. Presence of any severe/uncontrolled systemic diseases (e.g., respiratory, cardiovascular, gastrointestinal, neurological, hematological, urogenital, or endocrine disorders) or psychiatric disorders (e.g., Major Depressive Disorder, Schizophrenia, Bipolar Disorder) or other major illnesses, which in the Investigator's judgment could interfere with the provision of informed consent, make study participation unsafe, complicate the interpretation of study outcome data, or otherwise affect the achievement of study objectives.
• Potential need for hospitalization or surgery during the study period, including scheduled elective surgeries that cannot be postponed.
• Diagnosis of a Substance Use Disorder (other than alcohol or tobacco) based on DSM-5 criteria within the past year (prior to randomization/dosing), such as benzodiazepines, amphetamines, opioids, or cocaine.
• Use of anti-relapse medication (e.g., Naltrexone) or receipt of systemic psychological support therapy within 30 days prior to randomization/dosing.
• Currently receiving treatment for substance use disorders (e.g., opioids, amphetamines, alcohol), or received opioids within 7 days prior to randomization/dosing, or may require opioid treatment during the study; or positive urine drug screen for opioids, cannabis, amphetamines, etc., or positive naloxone challenge test on the day of randomization/dosing.
• Suicidal risk based on Investigator's clinical judgment, or history of suicidal or self-mutilating behavior.
• Allergy to the investigational product or its excipients (polylactic acid, magnesium stearate) or local anesthetics.
• Currently participating in any investigational drug or device study, or has used any investigational drug or device within 30 days prior to randomization/dosing.
• Skin infection at the implantation site, systemic skin disease, or keloid scarring that may affect the assessment of the investigational drug's efficacy and safety.
• Clinical or laboratory evidence of Human Immunodeficiency Virus (HIV) or Syphilis infection.

Sponsors & Collaborators

• Shenzhen Sciencare Medical Industries Co., Ltd.: lead

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 25, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share