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
Qualifiers
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
Treatments tested in this trial
- Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Seoul National University Hospital
Lead sponsor
Asan Medical Center
Collaborator
Uijeongbu Eulji University Hospital
Collaborator
Source ClinicalTrials.gov