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Naltrexone for Nonsuicidal Self-Injury

8 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

150

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Myeong-hyeon Mun, MD, Master's degree
  • Número de telefone: +821085171499
  • E-mail: psalms139@hanmail.net

Locais de estudo

  • Coréia do Sul
    • Gyeonggi-do
      • Uijeongbu-si, Gyeonggi-do, Coréia do Sul, 11759
        • Uijeongbu Eulji Medical Center
        • Contato:
    • Jongno-gu
      • Seoul, Jongno-gu, Coréia do Sul, 03080
        • Seoul National University Hospital
        • Contato:
    • Songpa-gu
      • Seoul, Songpa-gu, Coréia do Sul, 05505
        • Asan Medical Center
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Naltrexone Group
Participants will receive Naltrexone 50mg orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU).
Medicamento: Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)
Pure opioid antagonist administered 50mg once daily.
Comparador de Placebo: Placebo Group
Participants will receive a matching placebo orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU).
Medicamento: Placebo
Matching placebo indistinguishable from the active drug, administered once daily.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Total Number of Nonsuicidal Self-Injury Episodes During the 6-Week Treatment Period
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Modified Obsessive Compulsive Drinking Scale Adapted for Nonsuicidal Self-Injury Urges Total Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Seoul National University Hospital

Colaboradores

Asan Medical Center
Uijeongbu Eulji University Hospital

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

19 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de junho de 2026

Primeira postagem (Real)

11 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2024-0057

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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