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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Nonsuicidal Self-Injury

In brief

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

Key facts

Study ID

NCT06622239

Run by

Seoul National University Hospital

People needed

150

Starts

2026-06-01

Expected to finish

2027-05-31

Last updated by the study team

2026-05-22

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Seoul National University Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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