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Can a drug curb Self-Harm? new trial aims to find out

NCT ID NCT06622239

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether naltrexone, a medication, can help reduce nonsuicidal self-injury (like cutting or hitting oneself) in people aged 16 and older. About 150 participants will receive either naltrexone or a placebo, and researchers will track how often self-harm occurs. The goal is to see if the drug can lower these behaviors when standard psychiatric treatment hasn't worked.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 painkiller * currently opiate dependence * acute opiate withdrawal symptoms * naloxone-induced test is positive or the urine test is positive for opiates * have been sensitized to this drug * acute hepatitis, liver failure, severe liver failure * renal disease * hypersensitivity reaction to the main ingredient or other ingredients of this drug * a pregnant woman, a woman who may be pregnant, or a lactating woman * Since this drug contains lactose, genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc * active liver disease

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Conditions

The condition(s) this trial relates to.

Self-Injurious Behavior

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Seoul National University Hospital

    Seoul, 03080, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.