Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Naltrexone, Placebo.
- Who it may be relevant to
- Registry conditions: Nonsuicidal Self-Injury. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blinded Clinical Trial to Evaluate the Effects of Naltrexone in Improving Nonsuicidal Self-injurious Behavior
Overview
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.
Interventions
- Drug Naltrexone
naltrexone 50mg for 6 weeks - Drug Placebo
placebo for 6 weeks
Primary outcome measures
- Frequency of nonsuicidal self-injurous behavior [Time frame: 6 weeks]
Secondary outcome measures (4)
- Deliberate Self-harm Inventory [Time frame: 6 weeks]
- Clinical Global Impressions [Time frame: 6 weeks]
- Obsessive Compulsive Drinking Scale [Time frame: 6 weeks]
- Eating Disorder Examination-Questionnaire [Time frame: 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT06622239 · AYM-NiNsSIB