Can a drug curb Self-Harm? new trial aims to find out
NCT ID NCT06622239
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Seoul National University Hospital
Seoul, 03080, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an online program help teens stop Self-Injury?
- Can a smartphone app help young adults stop self-harming?
- Can an online program help teens stop self-harm? new study tests internet therapy