Clinical Trials in South Korea / NCT06622239
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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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