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NOT YET RECRUITING

NCT07641283

Naltrexone for Nonsuicidal Self-Injury

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blinded Clinical Trial to Evaluate the Effectiveness of Naltrexone in Improving Nonsuicidal Self-Injurious Behavior

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-06

Completion Date

2028-06

Last Updated

2026-06-11

Healthy Volunteers

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.

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.

Locations (3)

Uijeongbu Eulji Medical Center

Uijeongbu-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Asan medical center

Seoul, Songpa-gu, South Korea