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Naltrexone for Nonsuicidal Self-Injury

8 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

150

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Myeong-hyeon Mun, MD, Master's degree
  • Numer telefonu: +821085171499
  • E-mail: psalms139@hanmail.net

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Naltrexone Group
Participants will receive Naltrexone 50mg orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU).
Lek: Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)
Pure opioid antagonist administered 50mg once daily.
Komparator placebo: Placebo Group
Participants will receive a matching placebo orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU).
Lek: Placebo
Matching placebo indistinguishable from the active drug, administered once daily.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Total Number of Nonsuicidal Self-Injury Episodes During the 6-Week Treatment Period
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Modified Obsessive Compulsive Drinking Scale Adapted for Nonsuicidal Self-Injury Urges Total Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Seoul National University Hospital

Współpracownicy

Asan Medical Center
Uijeongbu Eulji University Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2027

Ukończenie studiów (Szacowany)

1 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

19 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

11 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2024-0057

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)

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