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Starting soon Phase 2

Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injury

NCT06622239 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 2
Started
2026-06-01
Last updated
2026-05-22

Condition(s) studied

Nonsuicidal Self-Injury

Investigational drug(s) / intervention(s)

Naltrexone →Placebo

Naltrexone: naltrexone 50mg for 6 weeks

Placebo: placebo for 6 weeks

Study summary

The goal of this clinical trial is to learn if naltrexone works to treat nonsuicidal self-injurious behavior in adolescents and adults.

Eligibility

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age: 16 years of age or older * Clinical interviews meet DSM-5\'s nonsuicidal self-injury diagnostic criteria * Nonsuicidal self-injurious behavior has been observed more than once in the past two months * Obsessive Compulsive Drinking Scale general craving item 2 or more points (strong desire) * Self-injurious behavior continues even with 4 weeks of general psychiatric treatment for underlying disease * Anyone who can independently read and fill out the questionnaire and speak Korean * Who understand the written consent and voluntarily agree to participate in the study * Female participants of childbearing age must be negative on urine pregnancy test at screening Exclusion Criteria: * currently in psychotic or manic conditions * currently experiencing serious suicidal thoughts * history of substance-related disorders including opioid * do not agree to use very effective contraception from the time of signing the test subject\'s consent form to the end of study period (non-fertility women and postmenopausal women excluded from the contraception requirements) * Severe medical conditions (angina pectoris, myocardial infarction, arrhythmia, any cancer that is not in remission, hypothyroidism, hyperthyroidism, diabetes, hepatitis B, hepatitis C, epilepsy, dementia, HIV infection) * intellectual disability or organic brain damage * difficulty reading and writing Korean * taking opioid antagonists (methadone, buprenorphine, etc.) * on an opiate painkiller * currently opiate dependence * acute opiate withdrawal symptoms * naloxone-induced test is positive or the urine test is positive for opiates * have been sensitized to this drug * acute hepatitis, liver failure, severe liver failure * renal disease * hypersensitivity reaction to the main ingredient or other ingredients of this drug * a pregnant woman, a woman who may be pregnant, or a lactating woman * Since this drug contains lactose, genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc * active liver disease

Primary outcome measure(s)

  • Frequency of nonsuicidal self-injurous behavior — 6 weeks
    Total number of nonsuicidal self-injurous behavior during study period

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06622239 on ClinicalTrials.gov ↗ ← All trials in South Korea