Nonsuicidal Self-InjuryPhase 2NiNsSIBNCT06622239
Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injury
A Phase 2 study testing Naltrexone in people with Nonsuicidal Self-Injury, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to learn if naltrexone works to treat nonsuicidal self-injurious behavior in adolescents and adults. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Nonsuicidal Self-Injury
- What is being tested?
- Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2026to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, 03080
Dae Hun Kang, M.D, 82-2-2072-2457, redlinnet@daum.net
About this study
Official title: A Randomized, Double-Blinded Clinical Trial to Evaluate the Effects of Naltrexone in Improving Nonsuicidal Self-injurious Behavior
The goal of this clinical trial is to learn if naltrexone works to treat nonsuicidal self-injurious behavior in adolescents and adults.
Read the 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.
- Conditions
- Nonsuicidal Self-Injury
- Being tested
- Naltrexone, Placebo
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Revia
naltrexone 50mg for 6 weeks
PlaceboDrug
placebo for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | naltrexone 50mg Receives: Drug: Naltrexone |
| comparison group | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of nonsuicidal self-injurous behavior
Total number of nonsuicidal self-injurous behavior during study period
Measured: 6 weeks
Secondary outcomes (4)
Deliberate Self-harm Inventory
change of NSSI frequency acquired by Deliberate Self-harm Inventory (the outcome of this scale does not have score)
Measured: 6 weeks
Clinical Global Impressions
change of Clinical Global Impressions scale the minimum and maximum values are 1 to 7, higher scores mean worse outcome
Measured: 6 weeks
Obsessive Compulsive Drinking Scale
change of Obsessive Compulsive Drinking Scale the minimum and mixiumum values are 0 to 40, higher scores mean a worse outcome
Measured: 6 weeks
Eating Disorder Examination-Questionnaire
change of Eating Disorder Examination-Questionnaire the minimum and mixiumum values are 0 to 6, higher scores mean a worse outcome
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Jun 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsuicidal Self-InjuryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Whanin Pharmaceutical Company
- Responsible party
- Principal investigator, Yong Min Ahn, Seoul National University Hospital
- Investigators
- Yong Min Ahn, M.D, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622239
- Sponsor's protocol ID
- AYM-NiNsSIB
- Acronym
- NiNsSIB
- Status last verified
- Mar 2026
- First submitted
- 11 Sep 2024
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided yet
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded Clinical Trial to Evaluate the Effects of Naltrexone in Improving Nonsuicidal Self-injurious Behavior
- ClinicalTrials.gov ID
- NCT06622239
- Acronym / sponsor ID
- NiNsSIB / AYM-NiNsSIB
- Conditions
- Nonsuicidal Self-Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Whanin Pharmaceutical Company
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Naltrexonenaltrexone 50mg |
| comparison group | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexoneAlso: Revianaltrexone 50mg for 6 weeks | Drug | experimental group |
| Placeboplacebo for 6 weeks | Drug | comparison group |
Primary outcome
Frequency of nonsuicidal self-injurous behavior
Time frame: 6 weeks
Total number of nonsuicidal self-injurous behavior during study period
4 secondary outcomes
Deliberate Self-harm Inventory
Time frame: 6 weeks
Clinical Global Impressions
Time frame: 6 weeks
Obsessive Compulsive Drinking Scale
Time frame: 6 weeks
Eating Disorder Examination-Questionnaire
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided. undecided yet
Related trials for Nonsuicidal Self-Injury
Not yet recruiting
Effects of a School-Based Trauma-Informed Psychosocial Competence Intervention on Nonsuicidal Self-Injury in Adolescents
Nonsuicidal Self-Injury
Not yet recruiting
A Pilot Study of a DBT-Informed Caregiver Risk Management Workshop
Caregivers, Suicide
Recruiting
Psychological Treatment for Adolescents With Self-injury Within Intensive Mental Health Outpatient Services: Randomized Controlled Pilot Trial
Nonsuicidal Self Injury, Nonsuicidal Self-Injury
Recruiting
Neuro- and Biofeedback in Nonsuicidal Self-injury
Nonsuicidal Self Injury, Emotion Regulation
Recruiting
Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury
Nonsuicidal Self-injury, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong Min Ahn, M.D, Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone in people with Nonsuicidal Self-Injury, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dae Hun Kang, M.D (82 + 02-2072-2457, redlinnet@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of nonsuicidal self-injurous behavior (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.