NCT06622239

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

A Randomized, Double-Blinded Clinical Trial to Evaluate the Effects of Naltrexone in Improving Nonsuicidal Self-injurious Behavior

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Recruiting participants with nonsuicidal self-injurious behavior and randomizing them to the experiment group and the control group at a 1:1 ratio, the test group administers the experiment drug naltrexone along with the general treatment, and the control group provides a placebo. Clinical evaluation including the frequency of self-injurious behavior is conducted every two weeks. The investigator and participants will double-blinded. Analyze the relationship between changes in clinical symptoms and socio-demographic characteristics, diagnosis, clinical characteristics, and anticipated to discover predictors of treatment effectiveness.

Conditions

• Nonsuicidal Self-Injury

Interventions

Type	Name	Description
DRUG	Naltrexone	naltrexone 50mg for 6 weeks
DRUG	Placebo	placebo for 6 weeks

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-02-28
• Completion: 2027-05-31
• First posted: 2024-10-02
• Last updated: 2024-10-04

Locations

1 site across 1 country: South Korea