Not Yet RecruitingPhase 2

Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injury

South Korea150 participantsStarted 2026-06-01

Plain-language summary

The goal of this clinical trial is to learn if naltrexone works to treat nonsuicidal self-injurious behavior in adolescents and adults.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 16 years of age or older * Clinical interviews meet DSM-5\'s nonsuicidal self-injury diagnostic criteria * Nonsuicidal self-injurious behavior has been observed more than once in the past two months * Obsessive Compulsive Drinking Scale general craving item 2 or more points (strong desire) * Self-injurious behavior continues even with 4 weeks of general psychiatric treatment for underlying disease * Anyone who can independently read and fill out the questionnaire and speak Korean * Who understand the written consent and voluntarily agree to participate in the study * Female participants of childbearing age must be negative on urine pregnancy test at screening Exclusion Criteria: * currently in psychotic or manic conditions * currently experiencing serious suicidal thoughts * history of substance-related disorders including opioid * do not agree to use very effective contraception from the time of signing the test subject\'s consent form to the end of study period (non-fertility women and postmenopausal women excluded from the contraception requirements) * Severe medical conditions (angina pectoris, myocardial infarction, arrhythmia, any cancer that is not in remission, hypothyroidism, hyperthyroidism, diabetes, hepatitis B, hepatitis C, epilepsy, dementia, HIV infection) * intellectual disability or organic brain damage * difficulty reading and writing Korean * taking opioid antagonists (methadone, buprenorphine, etc.) * on an opiate pain…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of nonsuicidal self-injurous behavior

Timeframe: 6 weeks

Trial details

NCT IDNCT06622239

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-28

Contact for this trial

Dae Hun Kang, M.D

82 + 02-2072-2457 redlinnet@daum.net

View on ClinicalTrials.gov More Nonsuicidal Self-Injury trials

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.