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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Nonsuicidal Self-Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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experimental group

naltrexone 50mg

Group Type EXPERIMENTAL

Naltrexone

Intervention Type DRUG

naltrexone 50mg for 6 weeks

comparison group

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo for 6 weeks

Interventions

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Naltrexone

naltrexone 50mg for 6 weeks

Intervention Type DRUG

Placebo

placebo for 6 weeks

Intervention Type DRUG

Other Intervention Names

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Revia

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No