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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Nonsuicidal Self-Injury
• Intervention / Treatment: Drug: Naltrexone; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dae Hun Kang, M.D; Phone Number: 82 + 02-2072-2457; Email: redlinnet@daum.net

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
    • Contact: Dae Hun Kang, M.D; Phone Number: 82-2-2072-2457; Email: redlinnet@daum.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; naltrexone 50mg	Drug: Naltrexone; naltrexone 50mg for 6 weeks; Other Names: Revia
Placebo Comparator: comparison group; placebo	Drug: Placebo; placebo for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of nonsuicidal self-injurous behavior	Total number of nonsuicidal self-injurous behavior during study period	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deliberate Self-harm Inventory	change of NSSI frequency acquired by Deliberate Self-harm Inventory (the outcome of this scale does not have score)	6 weeks
Clinical Global Impressions	change of Clinical Global Impressions scale the minimum and maximum values are 1 to 7, higher scores mean worse outcome	6 weeks
Obsessive Compulsive Drinking Scale	change of Obsessive Compulsive Drinking Scale the minimum and mixiumum values are 0 to 40, higher scores mean a worse outcome	6 weeks
Eating Disorder Examination-Questionnaire	change of Eating Disorder Examination-Questionnaire the minimum and mixiumum values are 0 to 6, higher scores mean a worse outcome	6 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Whanin Pharmaceutical Company
• Investigators: Principal Investigator: Yong Min Ahn, M.D, Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Self-Injurious Behavior; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Naloxone; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Naltrexone
• Other Study ID Numbers: AYM-NiNsSIB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: undecided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No