Naltrexone for Nonsuicidal Self-Injury

NCT07641283 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul National University Hospital

Phase

Not applicable

Started

2026-06

Last updated

2026-06-11

Condition(s) studied

Nonsuicidal Self-InjurySelf-Injurious Behavior

Investigational drug(s) / intervention(s)

Naltrexone 50mg (Whanin Naltrexone Tab. 50mg) →Placebo

Naltrexone 50mg (Whanin Naltrexone Tab. 50mg): Pure opioid antagonist administered 50mg once daily.

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

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.

Eligibility

Sex

ALL

Min age

16 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Participants must meet all of the following criteria: 1. Individuals aged 16 years or older. 2. Individuals with clinically significant nonsuicidal self-injurious behavior. 3. Individuals who are able to understand the study procedures and provide written informed consent. For minors, consent from a legal guardian and assent from the participant will be obtained according to applicable regulations. 4. Individuals who are able to comply with study procedures, including clinical visits, medication administration, and study assessments. 5. Women of childbearing potential must have a negative urine pregnancy test at screening and agree to use appropriate contraception during the study period. Exclusion Criteria: * Participants meeting any of the following criteria will be excluded: 1. Current serious suicidal ideation or high suicide risk, as determined by the investigator. 2. Current opioid use, opioid dependence, or use of opioid-containing medications. 3. Current use of opioid antagonists or medications that may interact with naltrexone, including methadone or buprenorphine. 4. Use of naltrexone within 1 week before screening. 5. Positive naloxone challenge test or positive urine opioid test, if applicable. 6. Known hypersensitivity to naltrexone or any component of the investigational product. 7. Active liver disease, active hepatitis, or clinically significant hepatic impairment. 8. Clinically significant renal impairment. 9. Pregnancy or breastfeeding. 10. Intellectual disability, organic brain disorder, or other condition that may interfere with the participant's ability to understand study procedures or complete assessments. 11. Inability to read or write Korean sufficiently to complete study assessments. 12. Documented prior non-response to naltrexone for nonsuicidal self-injury, as judged by the investigator. 13. Any other clinically significant medical or psychiatric condition that, in the opinion of the investigator, would make participation inappropriate or unsafe.

Primary outcome measure(s)

Total Number of Nonsuicidal Self-Injury Episodes During the 6-Week Treatment Period — Baseline to Week 6
The total number of nonsuicidal self-injury episodes during the 6-week treatment period will be assessed by blinded clinical evaluators. A lower number indicates fewer nonsuicidal self-injury episodes.

Trial sites (3)

Facility	City	Region
Uijeongbu Eulji Medical Center	Uijeongbu-si	Gyeonggi-do
Seoul National University Hospital	Seoul	Jongno-gu
Asan medical center	Seoul	Songpa-gu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07641283 on ClinicalTrials.gov ↗ ← All trials in South Korea