Clinical trial NCT06622239: Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injury
Official title: A Randomized, Double-Blinded Clinical Trial to Evaluate the Effects of Naltrexone in Improving Nonsuicidal Self-injurious Behavior
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Nonsuicidal Self-Injury
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Whanin Pharmaceutical Company
First posted: 2024-10-02
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age: 16 years of age or older
* Clinical interviews meet DSM-5\&#39;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\&#39;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

Primary outcomes:
measure: Frequency of nonsuicidal self-injurous behavior
timeFrame: 6 weeks
Secondary outcomes:
measure: Deliberate Self-harm Inventory
timeFrame: 6 weeks
measure: Clinical Global Impressions
timeFrame: 6 weeks
measure: Obsessive Compulsive Drinking Scale
timeFrame: 6 weeks
measure: Eating Disorder Examination-Questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yong Min Ahn, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: