Naltrexone for Nonsuicidal Self-Injury
8 de junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
150
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Myeong-hyeon Mun, MD, Master's degree
- Número de teléfono: +821085171499
- Correo electrónico: psalms139@hanmail.net
Ubicaciones de estudio
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Gyeonggi-do
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Uijeongbu-si, Gyeonggi-do, Corea del Sur, 11759
- Uijeongbu Eulji Medical Center
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Contacto:
- Minseok Hong, MD, PhD
- Número de teléfono: +821032289060
- Correo electrónico: garam21th@snu.ac.kr
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Jongno-gu
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Seoul, Jongno-gu, Corea del Sur, 03080
- Seoul National University Hospital
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Contacto:
- Myeong-hyeon Mun, MD, Master's degree
- Número de teléfono: +821085171499
- Correo electrónico: psalms139@hanmail.net
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Songpa-gu
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Seoul, Songpa-gu, Corea del Sur, 05505
- Asan Medical Center
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Contacto:
- Yujin Choi, Bachelor's Degree
- Número de teléfono: +821081194386
- Correo electrónico: dbwls14615@naver.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
Participants must meet all of the following criteria:
- Individuals aged 16 years or older.
- Individuals with clinically significant nonsuicidal self-injurious behavior.
- 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.
- Individuals who are able to comply with study procedures, including clinical visits, medication administration, and study assessments.
- 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:
- Current serious suicidal ideation or high suicide risk, as determined by the investigator.
- Current opioid use, opioid dependence, or use of opioid-containing medications.
- Current use of opioid antagonists or medications that may interact with naltrexone, including methadone or buprenorphine.
- Use of naltrexone within 1 week before screening.
- Positive naloxone challenge test or positive urine opioid test, if applicable.
- Known hypersensitivity to naltrexone or any component of the investigational product.
- Active liver disease, active hepatitis, or clinically significant hepatic impairment.
- Clinically significant renal impairment.
- Pregnancy or breastfeeding.
- Intellectual disability, organic brain disorder, or other condition that may interfere with the participant's ability to understand study procedures or complete assessments.
- Inability to read or write Korean sufficiently to complete study assessments.
- Documented prior non-response to naltrexone for nonsuicidal self-injury, as judged by the investigator.
- Any other clinically significant medical or psychiatric condition that, in the opinion of the investigator, would make participation inappropriate or unsafe.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Naltrexone Group
Participants will receive Naltrexone 50mg orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU).
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Pure opioid antagonist administered 50mg once daily.
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Comparador de placebos: Placebo Group
Participants will receive a matching placebo orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU).
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Matching placebo indistinguishable from the active drug, administered once daily.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Number of Nonsuicidal Self-Injury Episodes During the 6-Week Treatment Period
Periodo de tiempo: Baseline to Week 6
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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.
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Baseline to Week 6
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Modified Obsessive Compulsive Drinking Scale Adapted for Nonsuicidal Self-Injury Urges Total Score
Periodo de tiempo: Baseline, Week 2, Week 4, and Week 6
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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.
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Baseline, Week 2, Week 4, and Week 6
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Change From Baseline in Columbia-Suicide Severity Rating Scale Suicidal Ideation Severity Score
Periodo de tiempo: Baseline, Week 2, Week 4, and Week 6
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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.
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Baseline, Week 2, Week 4, and Week 6
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Change From Baseline in Clinical Global Impressions-Severity Score
Periodo de tiempo: 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.
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Baseline, Week 2, Week 4, and Week 6
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Number of Event-Based Ecological Momentary Assessment Reports of Nonsuicidal Self-Injury Urges
Periodo de tiempo: During the 6-week intervention period
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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.
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During the 6-week intervention period
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Number of Event-Based Ecological Momentary Assessment Reports of Nonsuicidal Self-Injury Behavior
Periodo de tiempo: 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.
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During the 6-week intervention period
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Percentage of Planned Investigational Product Doses Taken as Assessed by Pill Count
Periodo de tiempo: Week 2, Week 4, and Week 6
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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.
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Week 2, Week 4, and Week 6
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Number of Participants With Treatment-Emergent Adverse Events
Periodo de tiempo: Baseline through Week 6
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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.
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Baseline through Week 6
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Number of Participants With Clinically Significant Laboratory Abnormalities
Periodo de tiempo: Baseline and Week 6
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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.
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Baseline and Week 6
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Number of Participants With Clinically Significant Electrocardiogram Abnormalities
Periodo de tiempo: Baseline and Week 6
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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.
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Baseline and Week 6
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Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score
Periodo de tiempo: Baseline, Week 2, Week 4, and Week 6
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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.
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Baseline, Week 2, Week 4, and Week 6
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Change From Baseline in Hamilton Rating Scale for Anxiety Total Score
Periodo de tiempo: Baseline, Week 2, Week 4, and Week 6
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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.
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Baseline, Week 2, Week 4, and Week 6
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Change From Baseline in Patient Health Questionnaire-9 Total Score
Periodo de tiempo: Baseline, Week 2, Week 4, and Week 6
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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.
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Baseline, Week 2, Week 4, and Week 6
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Change From Baseline in Generalized Anxiety Disorder-7 Total Score
Periodo de tiempo: Baseline, Week 2, Week 4, and Week 6
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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.
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Baseline, Week 2, Week 4, and Week 6
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Change From Baseline in Eating Disorder Examination-Questionnaire Global Score
Periodo de tiempo: Baseline and Week 6
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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.
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Baseline and Week 6
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Clinical Global Impressions-Improvement Score
Periodo de tiempo: Week 2, Week 4, and Week 6
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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.
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Week 2, Week 4, and Week 6
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Weekly Positive Affect Score as Assessed by the Positive and Negative Affect Schedule
Periodo de tiempo: Weekly during the 6-week intervention period
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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.
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Weekly during the 6-week intervention period
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Weekly Negative Affect Score as Assessed by the Positive and Negative Affect Schedule
Periodo de tiempo: Weekly during the 6-week intervention period
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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.
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Weekly during the 6-week intervention period
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
- Bradburn NM, Rips LJ, Shevell SK. Answering autobiographical questions: the impact of memory and inference on surveys. Science. 1987 Apr 10;236(4798):157-61. doi: 10.1126/science.3563494.
- Clark DM, Teasdale JD. Diurnal variation in clinical depression and accessibility of memories of positive and negative experiences. J Abnorm Psychol. 1982 Apr;91(2):87-95. doi: 10.1037//0021-843x.91.2.87. No abstract available.
- Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
- Sonne S, Rubey R, Brady K, Malcolm R, Morris T. Naltrexone treatment of self-injurious thoughts and behaviors. J Nerv Ment Dis. 1996 Mar;184(3):192-5. doi: 10.1097/00005053-199603000-00011. No abstract available.
- Casner JA, Weinheimer B, Gualtieri CT. Naltrexone and self-injurious behavior: a retrospective population study. J Clin Psychopharmacol. 1996 Oct;16(5):389-94. doi: 10.1097/00004714-199610000-00008.
- Buzan RD, Thomas M, Dubovsky SL, Treadway J. The use of opiate antagonists for recurrent self-injurious behavior. J Neuropsychiatry Clin Neurosci. 1995 Fall;7(4):437-44. doi: 10.1176/jnp.7.4.437.
- Kars H, Broekema W, Glaudemans-van Gelderen I, Verhoeven WM, van Ree JM. Naltrexone attenuates self-injurious behavior in mentally retarded subjects. Biol Psychiatry. 1990 Apr 1;27(7):741-6. doi: 10.1016/0006-3223(90)90589-t.
- McCauley E, Berk MS, Asarnow JR, Adrian M, Cohen J, Korslund K, Avina C, Hughes J, Harned M, Gallop R, Linehan MM. Efficacy of Dialectical Behavior Therapy for Adolescents at High Risk for Suicide: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Aug 1;75(8):777-785. doi: 10.1001/jamapsychiatry.2018.1109.
- Mehlum L, Tormoen AJ, Ramberg M, Haga E, Diep LM, Laberg S, Larsson BS, Stanley BH, Miller AL, Sund AM, Groholt B. Dialectical behavior therapy for adolescents with repeated suicidal and self-harming behavior: a randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Oct;53(10):1082-91. doi: 10.1016/j.jaac.2014.07.003. Epub 2014 Jul 22.
- Aboujaoude E, Salame WO. Naltrexone: A Pan-Addiction Treatment? CNS Drugs. 2016 Aug;30(8):719-33. doi: 10.1007/s40263-016-0373-0.
- Bresin K, Gordon KH. Endogenous opioids and nonsuicidal self-injury: a mechanism of affect regulation. Neurosci Biobehav Rev. 2013 Mar;37(3):374-83. doi: 10.1016/j.neubiorev.2013.01.020. Epub 2013 Jan 20.
- Blasco-Fontecilla H, Fernandez-Fernandez R, Colino L, Fajardo L, Perteguer-Barrio R, de Leon J. The Addictive Model of Self-Harming (Non-suicidal and Suicidal) Behavior. Front Psychiatry. 2016 Feb 1;7:8. doi: 10.3389/fpsyt.2016.00008. eCollection 2016.
- Vega D, Sintes A, Fernandez M, Punti J, Soler J, Santamarina P, Soto A, Lara A, Mendez I, Martinez-Gimenez R, Romero S, Pascual JC. Review and update on non-suicidal self-injury: who, how and why? Actas Esp Psiquiatr. 2018 Jul;46(4):146-55. Epub 2018 Jul 1.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de junio de 2026
Publicado por primera vez (Actual)
11 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Síntomas de comportamiento
- Suicidio
- Comportamiento
- Ideación suicida
- Comportamiento impulsivo
- Comportamiento auto agresivo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, anillo fusionado
- Alcaloides
- Hidrocarburos aromáticos policíclicos
- Compuestos policíclicos
- Compuestos heterocíclicos, 4 o más anillos
- Naloxona
- Morfinanos
- Alcaloides opiáceos
- Compuestos heterocíclicos, anillo puente
- Fenantrenos
- Naltrexona
Otros números de identificación del estudio
- 2024-0057
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .