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

Phase 2

Not yet recruiting

• Conditions: Nonsuicidal Self-Injury
• Interventions: Drug: Naltrexone; Drug: Placebo

• Registration Number: NCT06622239
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-30
• Status Verified: 2024-10
• Study First Posted: 2024-10-02
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Study Start: 2024-12-01
• Primary Completion: 2027-02-28
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Naltrexone	naltrexone 50mg
comparison group	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
Frequency of nonsuicidal self-injurous behavior	6 weeks	Total number of nonsuicidal self-injurous behavior during study period

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of