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Naltrexone for Nonsuicidal Self-Injury

2026. június 8. frissítette: Yong Min Ahn, Seoul National University Hospital

A Randomized, Double-Blinded Clinical Trial to Evaluate the Effectiveness of Naltrexone in Improving Nonsuicidal Self-Injurious Behavior

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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

150

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Dél -Korea
    • Gyeonggi-do
      • Uijeongbu-si, Gyeonggi-do, Dél -Korea, 11759
        • Uijeongbu Eulji Medical Center
        • Kapcsolatba lépni:
    • Jongno-gu
      • Seoul, Jongno-gu, Dél -Korea, 03080
        • Seoul National University Hospital
        • Kapcsolatba lépni:
    • Songpa-gu
      • Seoul, Songpa-gu, Dél -Korea, 05505
        • Asan Medical Center
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Gyermek
  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Hármas

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Naltrexone Group
Participants will receive Naltrexone 50mg orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU).
Drog: Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)
Pure opioid antagonist administered 50mg once daily.
Placebo Comparator: Placebo Group
Participants will receive a matching placebo orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU).
Drog: Placebo
Matching placebo indistinguishable from the active drug, administered once daily.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Total Number of Nonsuicidal Self-Injury Episodes During the 6-Week Treatment Period
Időkeret: Baseline to Week 6
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.
Baseline to Week 6

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change From Baseline in Modified Obsessive Compulsive Drinking Scale Adapted for Nonsuicidal Self-Injury Urges Total Score
Időkeret: Baseline, Week 2, Week 4, and Week 6
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.
Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Columbia-Suicide Severity Rating Scale Suicidal Ideation Severity Score
Időkeret: Baseline, Week 2, Week 4, and Week 6
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.
Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Clinical Global Impressions-Severity Score
Időkeret: Baseline, Week 2, Week 4, and Week 6
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.
Baseline, Week 2, Week 4, and Week 6
Number of Event-Based Ecological Momentary Assessment Reports of Nonsuicidal Self-Injury Urges
Időkeret: During the 6-week intervention period
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.
During the 6-week intervention period
Number of Event-Based Ecological Momentary Assessment Reports of Nonsuicidal Self-Injury Behavior
Időkeret: During the 6-week intervention period
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.
During the 6-week intervention period
Percentage of Planned Investigational Product Doses Taken as Assessed by Pill Count
Időkeret: Week 2, Week 4, and Week 6
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.
Week 2, Week 4, and Week 6
Number of Participants With Treatment-Emergent Adverse Events
Időkeret: Baseline through Week 6
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.
Baseline through Week 6
Number of Participants With Clinically Significant Laboratory Abnormalities
Időkeret: Baseline and Week 6
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.
Baseline and Week 6
Number of Participants With Clinically Significant Electrocardiogram Abnormalities
Időkeret: Baseline and Week 6
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.
Baseline and Week 6
Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score
Időkeret: Baseline, Week 2, Week 4, and Week 6
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.
Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Hamilton Rating Scale for Anxiety Total Score
Időkeret: Baseline, Week 2, Week 4, and Week 6
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.
Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Patient Health Questionnaire-9 Total Score
Időkeret: Baseline, Week 2, Week 4, and Week 6
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.
Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Generalized Anxiety Disorder-7 Total Score
Időkeret: Baseline, Week 2, Week 4, and Week 6
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.
Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Eating Disorder Examination-Questionnaire Global Score
Időkeret: Baseline and Week 6
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.
Baseline and Week 6
Clinical Global Impressions-Improvement Score
Időkeret: Week 2, Week 4, and Week 6
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.
Week 2, Week 4, and Week 6
Weekly Positive Affect Score as Assessed by the Positive and Negative Affect Schedule
Időkeret: Weekly during the 6-week intervention period
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.
Weekly during the 6-week intervention period
Weekly Negative Affect Score as Assessed by the Positive and Negative Affect Schedule
Időkeret: Weekly during the 6-week intervention period
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.
Weekly during the 6-week intervention period

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Seoul National University Hospital

Együttműködők

Asan Medical Center
Uijeongbu Eulji University Hospital

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. június 1.

Elsődleges befejezés (Becsült)

2027. december 1.

A tanulmány befejezése (Becsült)

2028. június 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. május 19.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. június 8.

Első közzététel (Tényleges)

2026. június 11.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. június 11.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. június 8.

Utolsó ellenőrzés

2026. május 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 2024-0057

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

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.

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