Naltrexone for Nonsuicidal Self-Injury

NCT07641283 | Not Yet Recruiting

• 1 other identifier: 2024-0057
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Nonsuicidal Self-Injury; Self-Injurious Behavior

Keywords

Nonsuicidal self-injury; NSSI; Self-injurious behavior; Naltrexone; Opioid antagonist; Impulsivity; Suicidal ideation; Ecological momentary assessment

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 6

Secondary Outcomes (17)

• Change From Baseline in Modified Obsessive Compulsive Drinking Scale Adapted for Nonsuicidal Self-Injury Urges Total Score

  Baseline, Week 2, Week 4, and Week 6

• Change From Baseline in Columbia-Suicide Severity Rating Scale Suicidal Ideation Severity Score

  Baseline, Week 2, Week 4, and Week 6

• Change From Baseline in Clinical Global Impressions-Severity Score

  Baseline, Week 2, Week 4, and Week 6

• Number of Event-Based Ecological Momentary Assessment Reports of Nonsuicidal Self-Injury Urges

  During the 6-week intervention period

• Number of Event-Based Ecological Momentary Assessment Reports of Nonsuicidal Self-Injury Behavior

  During the 6-week intervention period

Study Arms (2)

Naltrexone Group

EXPERIMENTAL

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)

Placebo Group

PLACEBO COMPARATOR

Participants will receive a matching placebo orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU).

Drug: Placebo

Interventions

Placebo DRUG

Matching placebo indistinguishable from the active drug, administered once daily.

Placebo Group

Naltrexone 50mg (Whanin Naltrexone Tab. 50mg) DRUG

Pure opioid antagonist administered 50mg once daily.

Naltrexone Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Asan Medical Center: collaborator
• Uijeongbu Eulji University Hospital: collaborator

Study Sites (3)

Uijeongbu Eulji Medical Center

Uijeongbu-si, Gyeonggi-do, 11759, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Asan medical center

Seoul, Songpa-gu, 05505, South Korea

Location

Related Publications (14)

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MeSH Terms

Conditions

Self-Injurious Behavior; Impulsive Behavior; Suicidal Ideation

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Myeong-hyeon Mun, MD, Master's Degree

CONTACT

+821085171499; psalms139@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and clinical outcome assessors will be blinded to treatment allocation. Randomization and investigational product assignment will be managed separately by designated unblinded personnel who are not involved in clinical outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either naltrexone plus treatment as usual or placebo plus treatment as usual.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)