Naltrexone for Nonsuicidal Self-Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorSeoul National University Hospital
About this trial
This randomized, double-blinded, placebo-controlled clinical trial aims to evaluate the efficacy and safety of naltrexone in reducing nonsuicidal self-injurious behavior among individuals with nonsuicidal self-injury. Participants will be randomly assigned to receive either naltrexone plus treatment as usual or placebo plus treatment as usual for 6 weeks.
The primary objective is to determine whether naltrexone reduces the frequency of nonsuicidal self-injurious behavior compared with placebo. Secondary objectives include evaluating changes in clinical severity, suicidal ideation, self-injury-related urges, ecological momentary assessment measures, and safety outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 16 years or older.
Individuals with clinically significant nonsuicidal self-injurious behavior.
Individuals who are able to understand the study procedures and provide written informed consent. For minors, consent from a legal guardian and assent from the participant will be obtained according to applicable regulations.
Individuals who are able to comply with study procedures, including clinical visits, medication administration, and study assessments.
Disqualifiers
Current serious suicidal ideation or high suicide risk, as determined by the investigator.
Current opioid use, opioid dependence, or use of opioid-containing medications.
Current use of opioid antagonists or medications that may interact with naltrexone, including methadone or buprenorphine.
Use of naltrexone within 1 week before screening.
Trial design
Design model
Parallel
Treatments tested in this trial
Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)
DrugPure opioid antagonist administered 50mg once daily.
Placebo
DrugMatching placebo indistinguishable from the active drug, administered once daily.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Naltrexone GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total Number of Nonsuicidal Self-Injury Episodes During the 6-Week Treatment Period
The total number of nonsuicidal self-injury episodes during the 6-week treatment period will be assessed by blinded clinical evaluators. A lower number indicates fewer nonsuicidal self-injury episodes.
Time frame
Baseline to Week 6Secondary outcomes
1
Change From Baseline in Modified Obsessive Compulsive Drinking Scale Adapted for Nonsuicidal Self-Injury Urges Total Score
Self-injurious urges will be assessed using the Modified Obsessive Compulsive Drinking Scale adapted for nonsuicidal self-injury urges. The total score ranges from 0 to 56, with higher scores indicating more severe self-injurious urges.
Time frame
Baseline, Week 2, Week 4, and Week 62
Change From Baseline in Columbia-Suicide Severity Rating Scale Suicidal Ideation Severity Score
Suicidal ideation will be assessed using the Columbia-Suicide Severity Rating Scale suicidal ideation severity score. The score ranges from 0 to 5, with higher scores indicating more severe suicidal ideation.
Time frame
Baseline, Week 2, Week 4, and Week 63
Change From Baseline in Clinical Global Impressions-Severity Score
Overall clinical severity will be assessed using the Clinical Global Impressions-Severity scale. The score ranges from 1 to 7, with higher scores indicating greater illness severity.
Time frame
Baseline, Week 2, Week 4, and Week 64
Number of Event-Based Ecological Momentary Assessment Reports of Nonsuicidal Self-Injury Urges
Participants will complete an event-based smartphone ecological momentary assessment entry when they experience nonsuicidal self-injury urges. The outcome will be reported as the total number of event-based reports of nonsuicidal self-injury urges. A higher number indicates more frequent self-injurious urges.
Time frame
During the 6-week intervention periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Hospital
Lead sponsor
Asan Medical Center
Collaborator
Uijeongbu Eulji University Hospital
Collaborator
Source ClinicalTrials.gov
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