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

Seoul National University

Status and phase: Not yet enrolling; Phase 2

Conditions: Nonsuicidal Self-Injury

Treatments: Drug: Naltrexone; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06622239

AYM-NiNsSIB

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

experimental group

Experimental group

Description:

naltrexone 50mg

Treatment:

Drug: Naltrexone

comparison group

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo