MedTrace Logo

Naltrexone for Nonsuicidal Self-Injury

NCT07641283 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-06-11

No results posted yet for this study

Summary

This randomized, double-blinded, placebo-controlled clinical trial aims to evaluate the efficacy and safety of naltrexone in reducing nonsuicidal self-injurious behavior among individuals with nonsuicidal self-injury. Participants will be randomly assigned to receive either naltrexone plus treatment as usual or placebo plus treatment as usual for 6 weeks.

The primary objective is to determine whether naltrexone reduces the frequency of nonsuicidal self-injurious behavior compared with placebo. Secondary objectives include evaluating changes in clinical severity, suicidal ideation, self-injury-related urges, ecological momentary assessment measures, and safety outcomes.

Conditions

  • Nonsuicidal Self-Injury
  • Self-Injurious Behavior

Interventions

DRUG

Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)

Pure opioid antagonist administered 50mg once daily.

DRUG

Placebo

Matching placebo indistinguishable from the active drug, administered once daily.

Sponsors & Collaborators

  • Asan Medical Center

    collaborator OTHER

  • Uijeongbu Eulji University Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

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 NCT07641283 on ClinicalTrials.gov