Nonsuicidal Self-Injury
Conditions
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.
Interventions
DRUGNaltrexone
naltrexone 50mg for 6 weeks
DRUGPlacebo
placebo for 6 weeks
Sponsors
Seoul National University Hospital
Whanin Pharmaceutical Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of nonsuicidal self-injurous behavior | 6 weeks | Total number of nonsuicidal self-injurous behavior during study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Countries
South Korea
Contacts
CONTACTDae Hun Kang, M.D
PRINCIPAL_INVESTIGATORYong Min Ahn, M.D, Ph.D
Seoul National University Hospital
Outcome results
None listed