An interventional study of Naltrexone 50mg (Whanin Naltrexone Tab. 50mg) and Placebo in Nonsuicidal Self-Injury and Self-Injurious Behavior, sponsored by Seoul National University Hospital. Not yet recruiting at 3 sites in South Korea. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
Nonsuicidal self-injury is defined as the intentional destruction of one's own body tissue without suicidal intent. It is clinically important because it is associated with emotional dysregulation, impulsivity, psychiatric comorbidity, and increased risk of future suicidal behavior. However, evidence-based pharmacological treatments specifically targeting nonsuicidal self-injurious behavior remain limited.
Naltrexone is an opioid receptor antagonist that has been suggested to reduce repetitive self-injurious behaviors by modulating endogenous opioid-related reinforcement mechanisms. This study will investigate whether naltrexone is effective in reducing nonsuicidal self-injurious behavior in a randomized, double-blinded, placebo-controlled design.
A total of 150 participants will be enrolled across multiple study sites. Eligible participants will be randomly assigned in a 1:1 ratio to either the naltrexone group or the placebo group. The intervention period will last 6 weeks, with clinical evaluations conducted at baseline and every 2 weeks thereafter. Smartphone-based ecological momentary assessment will also be used to monitor self-injurious urges, mood states, and related behavioral variables during the study period.
Safety will be assessed throughout the study through adverse event monitoring, assessment of suicidal ideation and behavior, laboratory testing, urine testing, and electrocardiography according to the study schedule.
303 studies on the registry are indexed under Self-Injurious Behavior; 105 are open to participants now.
This study's planned enrollment of 150 is above the median of 70 across 254 interventional studies indexed under Self-Injurious Behavior.
Browse Self-Injurious Behavior studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Naltrexone 50mg orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU).
Drug: Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)
Participants will receive a matching placebo orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU).
Drug: Placebo
Pure opioid antagonist administered 50mg once daily.
Matching placebo indistinguishable from the active drug, administered once daily.
Total Number of Nonsuicidal Self-Injury Episodes During the 6-Week Treatment Period
The total number of nonsuicidal self-injury episodes during the 6-week treatment period will be assessed by blinded clinical evaluators. A lower number indicates fewer nonsuicidal self-injury episodes.
Time frame: Baseline to Week 6
Change From Baseline in Modified Obsessive Compulsive Drinking Scale Adapted for Nonsuicidal Self-Injury Urges Total Score
Self-injurious urges will be assessed using the Modified Obsessive Compulsive Drinking Scale adapted for nonsuicidal self-injury urges. The total score ranges from 0 to 56, with higher scores indicating more severe self-injurious urges.
Time frame: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Columbia-Suicide Severity Rating Scale Suicidal Ideation Severity Score
Suicidal ideation will be assessed using the Columbia-Suicide Severity Rating Scale suicidal ideation severity score. The score ranges from 0 to 5, with higher scores indicating more severe suicidal ideation.
Time frame: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Clinical Global Impressions-Severity Score
Overall clinical severity will be assessed using the Clinical Global Impressions-Severity scale. The score ranges from 1 to 7, with higher scores indicating greater illness severity.
Time frame: Baseline, Week 2, Week 4, and Week 6
Number of Event-Based Ecological Momentary Assessment Reports of Nonsuicidal Self-Injury Urges
Participants will complete an event-based smartphone ecological momentary assessment entry when they experience nonsuicidal self-injury urges. The outcome will be reported as the total number of event-based reports of nonsuicidal self-injury urges. A higher number indicates more frequent self-injurious urges.
Time frame: During the 6-week intervention period
Number of Event-Based Ecological Momentary Assessment Reports of Nonsuicidal Self-Injury Behavior
Participants will complete an event-based smartphone ecological momentary assessment entry when nonsuicidal self-injury behavior occurs. The outcome will be reported as the total number of event-based reports of nonsuicidal self-injury behavior. A higher number indicates more frequent nonsuicidal self-injury behavior.
Time frame: During the 6-week intervention period
Percentage of Planned Investigational Product Doses Taken as Assessed by Pill Count
Medication adherence will be assessed using pill count. Adherence will be calculated as the number of doses taken divided by the number of planned doses, multiplied by 100. The percentage ranges from 0% to 100%, with higher percentages indicating greater adherence.
Time frame: Week 2, Week 4, and Week 6
Number of Participants With Treatment-Emergent Adverse Events
Treatment-emergent adverse events will be assessed throughout the study period. The outcome will be reported as the number of participants with one or more treatment-emergent adverse events.
Time frame: Baseline through Week 6
Number of Participants With Clinically Significant Laboratory Abnormalities
Laboratory safety will be assessed using prespecified blood and urine tests. The outcome will be reported as the number of participants with clinically significant laboratory abnormalities as judged by the investigator.
Time frame: Baseline and Week 6
Number of Participants With Clinically Significant Electrocardiogram Abnormalities
Electrocardiogram safety will be assessed using standard electrocardiography. The outcome will be reported as the number of participants with clinically significant electrocardiogram abnormalities as judged by the investigator.
Time frame: Baseline and Week 6
Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score
Depressive symptoms will be assessed using the Montgomery-Åsberg Depression Rating Scale. The total score ranges from 0 to 60, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Hamilton Rating Scale for Anxiety Total Score
Anxiety symptoms will be assessed using the Hamilton Rating Scale for Anxiety. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms.
Time frame: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Patient Health Questionnaire-9 Total Score
Self-reported depressive symptoms will be assessed using the Patient Health Questionnaire-9. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Generalized Anxiety Disorder-7 Total Score
Self-reported anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 scale. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Time frame: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Eating Disorder Examination-Questionnaire Global Score
Eating disorder-related psychopathology will be assessed using the Eating Disorder Examination-Questionnaire global score. The global score ranges from 0 to 6, with higher scores indicating greater eating disorder-related psychopathology.
Time frame: Baseline and Week 6
Clinical Global Impressions-Improvement Score
Overall clinical improvement will be assessed using the Clinical Global Impressions-Improvement scale. The score ranges from 1 to 7, where 1 indicates very much improved and 7 indicates very much worse. Lower scores indicate greater improvement.
Time frame: Week 2, Week 4, and Week 6
Weekly Positive Affect Score as Assessed by the Positive and Negative Affect Schedule
Positive affect will be assessed weekly using the Positive and Negative Affect Schedule positive affect subscale through smartphone-based ecological momentary assessment. The positive affect subscale score ranges from 10 to 50, with higher scores indicating greater positive affect.
Time frame: Weekly during the 6-week intervention period
Weekly Negative Affect Score as Assessed by the Positive and Negative Affect Schedule
Negative affect will be assessed weekly using the Positive and Negative Affect Schedule negative affect subscale through smartphone-based ecological momentary assessment. The negative affect subscale score ranges from 10 to 50, with higher scores indicating greater negative affect.
Time frame: Weekly during the 6-week intervention period
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be publicly shared due to privacy and ethical restrictions. De-identified data may be made available from the corresponding investigator upon reasonable request and with appropriate institutional approval.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Naltrexone
Seoul National University Hospital →