Naltrexone for Nonsuicidal Self-Injury

Starting soon · Not applicable · Has a placebo group

Conditions studied: Nonsuicidal Self-Injury, Self-Injurious Behavior

In brief

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.

Key facts

Study ID

NCT07641283

Run by

Seoul National University Hospital

People needed

150

Starts

2026-06-01

Expected to finish

2028-06-01

Last updated by the study team

2026-06-11

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all of the following criteria:
• Individuals aged 16 years or older.
• Individuals with clinically significant nonsuicidal self-injurious behavior.
• 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.
• Individuals who are able to comply with study procedures, including clinical visits, medication administration, and study assessments.
• Women of childbearing potential must have a negative urine pregnancy test at screening and agree to use appropriate contraception during the study period.

You may not qualify if…

• Participants meeting any of the following criteria will be excluded:
• Current serious suicidal ideation or high suicide risk, as determined by the investigator.
• Current opioid use, opioid dependence, or use of opioid-containing medications.
• Current use of opioid antagonists or medications that may interact with naltrexone, including methadone or buprenorphine.
• Use of naltrexone within 1 week before screening.
• Positive naloxone challenge test or positive urine opioid test, if applicable.
• Known hypersensitivity to naltrexone or any component of the investigational product.
• Active liver disease, active hepatitis, or clinically significant hepatic impairment.
• Clinically significant renal impairment.
• Pregnancy or breastfeeding.
• Intellectual disability, organic brain disorder, or other condition that may interfere with the participant's ability to understand study procedures or complete assessments.
• Inability to read or write Korean sufficiently to complete study assessments.
• Documented prior non-response to naltrexone for nonsuicidal self-injury, as judged by the investigator.
• Any other clinically significant medical or psychiatric condition that, in the opinion of the investigator, would make participation inappropriate or unsafe.

Where it is running

• 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

Full record on ClinicalTrials.gov

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