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

NCT ID NCT07641283

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether naltrexone, a drug already used for addiction, can help people who hurt themselves without intending suicide. About 150 people will receive either naltrexone or a placebo daily for 6 weeks, alongside their usual care. Researchers will track how many self-injury episodes occur and whether urges decrease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
naltrexone
What this could lead to
If it works, this could point toward a medication to help reduce urges and episodes of self-injury.
What could go wrong
This is a small, early-stage trial with only 6 weeks of treatment. The drug may not reduce self-injury more than placebo, and side effects are possible.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

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

Jun 2028

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: * 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.

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Conditions

The condition(s) this trial relates to.

Impulsive Behavior Self-Injurious Behavior Suicidal Ideation

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

    3 sites. 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

  • Asan medical center

    Seoul, Songpa-gu, 05505, South Korea

  • Seoul National University Hospital

    Seoul, Jongno-gu, 03080, South Korea

  • Uijeongbu Eulji Medical Center

    Uijeongbu-si, Gyeonggi-do, 11759, South Korea

More trials for these conditions

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