Nonsuicidal Self-InjuryNCT07641283
Naltrexone for Nonsuicidal Self-Injury
A study testing Naltrexone 50mg (Whanin Naltrexone Tab. 50mg) in people with Nonsuicidal Self-Injury and Self-Injurious Behavior, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Nonsuicidal Self-Injury, Self-Injurious Behavior
- What is being tested?
- Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jun 2026to Jun 2028
- Phase
- Interventional
- 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
- Participants must meet all of the following criteria:
- 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.
- Women of childbearing potential must have a negative urine pregnancy test at screening and agree to use appropriate contraception during the study period.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- 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.
- Positive naloxone challenge test or positive urine opioid test, if applicable.
Show all 14Show fewer
- Known hypersensitivity to naltrexone or any component of the investigational product.
- Active liver disease, active hepatitis, or clinically significant hepatic impairment.
- Clinically significant renal impairment.
- Pregnancy or breastfeeding.
- Intellectual disability, organic brain disorder, or other condition that may interfere with the participant's ability to understand study procedures or complete assessments.
- Inability to read or write Korean sufficiently to complete study assessments.
- Documented prior non-response to naltrexone for nonsuicidal self-injury, as judged by the investigator.
- Any other clinically significant medical or psychiatric condition that, in the opinion of the investigator, would make participation inappropriate or unsafe.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Myeong-hyeon Mun, MD, Master's degree, +821085171499, psalms139@hanmail.net
Asan medical center
Seoul, Songpa-gu, 05505
Yujin Choi, Bachelor's Degree, +821081194386, dbwls14615@naver.com
Uijeongbu Eulji Medical Center
Uijeongbu-si, Gyeonggi-do, 11759
Minseok Hong, MD, PhD, +821032289060, garam21th@snu.ac.kr
About this study
Official title: A Randomized, Double-Blinded Clinical Trial to Evaluate the Effectiveness of Naltrexone in Improving Nonsuicidal Self-Injurious Behavior
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.
Read the detailed description
Nonsuicidal self-injury is defined as the intentional destruction of one's own body tissue without suicidal intent. It is clinically important because it is associated with emotional dysregulation, impulsivity, psychiatric comorbidity, and increased risk of future suicidal behavior. However, evidence-based pharmacological treatments specifically targeting nonsuicidal self-injurious behavior remain limited.
Naltrexone is an opioid receptor antagonist that has been suggested to reduce repetitive self-injurious behaviors by modulating endogenous opioid-related reinforcement mechanisms. This study will investigate whether naltrexone is effective in reducing nonsuicidal self-injurious behavior in a randomized, double-blinded, placebo-controlled design.
A total of 150 participants will be enrolled across multiple study sites. Eligible participants will be randomly assigned in a 1:1 ratio to either the naltrexone group or the placebo group. The intervention period will last 6 weeks, with clinical evaluations conducted at baseline and every 2 weeks thereafter. Smartphone-based ecological momentary assessment will also be used to monitor self-injurious urges, mood states, and related behavioral variables during the study period.
Safety will be assessed throughout the study through adverse event monitoring, assessment of suicidal ideation and behavior, laboratory testing, urine testing, and electrocardiography according to the study schedule.
- Conditions
- Nonsuicidal Self-Injury, Self-Injurious Behavior
- Being tested
- Naltrexone 50mg (Whanin Naltrexone Tab. 50mg), Placebo
- Keywords
- Nonsuicidal self-injury, NSSI, Self-injurious behavior, Naltrexone, Opioid antagonist, Impulsivity, Suicidal ideation, Ecological momentary assessment
- Medical subject headings
- Self-Injurious Behavior, Impulsive Behavior, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)Drug
Pure opioid antagonist administered 50mg once daily.
PlaceboDrug
Matching placebo indistinguishable from the active drug, administered once daily.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone Group | Experimental | Participants will receive Naltrexone 50mg orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU). Receives: Drug: Naltrexone 50mg (Whanin Naltrexone Tab. 50mg) |
| Placebo Group | Placebo comparator | Participants will receive a matching placebo orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 6
Secondary outcomes (17)
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.
Measured: Baseline, Week 2, Week 4, and Week 6
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.
Measured: Baseline, Week 2, Week 4, and Week 6
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.
Measured: Baseline, Week 2, Week 4, and Week 6
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.
Measured: During the 6-week intervention period
Number of Event-Based Ecological Momentary Assessment Reports of Nonsuicidal Self-Injury Behavior
Participants will complete an event-based smartphone ecological momentary assessment entry when nonsuicidal self-injury behavior occurs. The outcome will be reported as the total number of event-based reports of nonsuicidal self-injury behavior. A higher number indicates more frequent nonsuicidal self-injury behavior.
Measured: During the 6-week intervention period
Percentage of Planned Investigational Product Doses Taken as Assessed by Pill Count
Medication adherence will be assessed using pill count. Adherence will be calculated as the number of doses taken divided by the number of planned doses, multiplied by 100. The percentage ranges from 0% to 100%, with higher percentages indicating greater adherence.
Measured: Week 2, Week 4, and Week 6
Number of Participants With Treatment-Emergent Adverse Events
Treatment-emergent adverse events will be assessed throughout the study period. The outcome will be reported as the number of participants with one or more treatment-emergent adverse events.
Measured: Baseline through Week 6
Number of Participants With Clinically Significant Laboratory Abnormalities
Laboratory safety will be assessed using prespecified blood and urine tests. The outcome will be reported as the number of participants with clinically significant laboratory abnormalities as judged by the investigator.
Measured: Baseline and Week 6
Number of Participants With Clinically Significant Electrocardiogram Abnormalities
Electrocardiogram safety will be assessed using standard electrocardiography. The outcome will be reported as the number of participants with clinically significant electrocardiogram abnormalities as judged by the investigator.
Measured: Baseline and Week 6
Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score
Depressive symptoms will be assessed using the Montgomery-Åsberg Depression Rating Scale. The total score ranges from 0 to 60, with higher scores indicating more severe depressive symptoms.
Measured: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Hamilton Rating Scale for Anxiety Total Score
Anxiety symptoms will be assessed using the Hamilton Rating Scale for Anxiety. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms.
Measured: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Patient Health Questionnaire-9 Total Score
Self-reported depressive symptoms will be assessed using the Patient Health Questionnaire-9. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Generalized Anxiety Disorder-7 Total Score
Self-reported anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 scale. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Eating Disorder Examination-Questionnaire Global Score
Eating disorder-related psychopathology will be assessed using the Eating Disorder Examination-Questionnaire global score. The global score ranges from 0 to 6, with higher scores indicating greater eating disorder-related psychopathology.
Measured: Baseline and Week 6
Clinical Global Impressions-Improvement Score
Overall clinical improvement will be assessed using the Clinical Global Impressions-Improvement scale. The score ranges from 1 to 7, where 1 indicates very much improved and 7 indicates very much worse. Lower scores indicate greater improvement.
Measured: Week 2, Week 4, and Week 6
Weekly Positive Affect Score as Assessed by the Positive and Negative Affect Schedule
Positive affect will be assessed weekly using the Positive and Negative Affect Schedule positive affect subscale through smartphone-based ecological momentary assessment. The positive affect subscale score ranges from 10 to 50, with higher scores indicating greater positive affect.
Measured: Weekly during the 6-week intervention period
Weekly Negative Affect Score as Assessed by the Positive and Negative Affect Schedule
Negative affect will be assessed weekly using the Positive and Negative Affect Schedule negative affect subscale through smartphone-based ecological momentary assessment. The negative affect subscale score ranges from 10 to 50, with higher scores indicating greater negative affect.
Measured: Weekly during the 6-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either naltrexone plus treatment as usual or placebo plus treatment as usual.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Uijeongbu Eulji University Hospital
- Responsible party
- Principal investigator, Yong Min Ahn, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641283
- Sponsor's protocol ID
- 2024-0057
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to privacy and ethical restrictions. De-identified data may be made available from the corresponding investigator upon reasonable request and with appropriate institutional approval.
Publications
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
PubMed 31078660Bradburn NM, Rips LJ, Shevell SK. Answering autobiographical questions: the impact of memory and inference on surveys. Science. 1987 Apr 10;236(4798):157-61. doi: 10.1126/science.3563494.
PubMed 3563494Clark DM, Teasdale JD. Diurnal variation in clinical depression and accessibility of memories of positive and negative experiences. J Abnorm Psychol. 1982 Apr;91(2):87-95. doi: 10.1037//0021-843x.91.2.87. No abstract available.
PubMed 7200102Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
PubMed 18509902Sonne S, Rubey R, Brady K, Malcolm R, Morris T. Naltrexone treatment of self-injurious thoughts and behaviors. J Nerv Ment Dis. 1996 Mar;184(3):192-5. doi: 10.1097/00005053-199603000-00011. No abstract available.
PubMed 8600226Casner JA, Weinheimer B, Gualtieri CT. Naltrexone and self-injurious behavior: a retrospective population study. J Clin Psychopharmacol. 1996 Oct;16(5):389-94. doi: 10.1097/00004714-199610000-00008.
PubMed 8889912Buzan RD, Thomas M, Dubovsky SL, Treadway J. The use of opiate antagonists for recurrent self-injurious behavior. J Neuropsychiatry Clin Neurosci. 1995 Fall;7(4):437-44. doi: 10.1176/jnp.7.4.437.
PubMed 8555746Kars H, Broekema W, Glaudemans-van Gelderen I, Verhoeven WM, van Ree JM. Naltrexone attenuates self-injurious behavior in mentally retarded subjects. Biol Psychiatry. 1990 Apr 1;27(7):741-6. doi: 10.1016/0006-3223(90)90589-t.
PubMed 2158355McCauley E, Berk MS, Asarnow JR, Adrian M, Cohen J, Korslund K, Avina C, Hughes J, Harned M, Gallop R, Linehan MM. Efficacy of Dialectical Behavior Therapy for Adolescents at High Risk for Suicide: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Aug 1;75(8):777-785. doi: 10.1001/jamapsychiatry.2018.1109.
PubMed 29926087Mehlum L, Tormoen AJ, Ramberg M, Haga E, Diep LM, Laberg S, Larsson BS, Stanley BH, Miller AL, Sund AM, Groholt B. Dialectical behavior therapy for adolescents with repeated suicidal and self-harming behavior: a randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Oct;53(10):1082-91. doi: 10.1016/j.jaac.2014.07.003. Epub 2014 Jul 22.
PubMed 25245352Aboujaoude E, Salame WO. Naltrexone: A Pan-Addiction Treatment? CNS Drugs. 2016 Aug;30(8):719-33. doi: 10.1007/s40263-016-0373-0.
PubMed 27401883Bresin K, Gordon KH. Endogenous opioids and nonsuicidal self-injury: a mechanism of affect regulation. Neurosci Biobehav Rev. 2013 Mar;37(3):374-83. doi: 10.1016/j.neubiorev.2013.01.020. Epub 2013 Jan 20.
PubMed 23339875Blasco-Fontecilla H, Fernandez-Fernandez R, Colino L, Fajardo L, Perteguer-Barrio R, de Leon J. The Addictive Model of Self-Harming (Non-suicidal and Suicidal) Behavior. Front Psychiatry. 2016 Feb 1;7:8. doi: 10.3389/fpsyt.2016.00008. eCollection 2016.
PubMed 26869941Vega D, Sintes A, Fernandez M, Punti J, Soler J, Santamarina P, Soto A, Lara A, Mendez I, Martinez-Gimenez R, Romero S, Pascual JC. Review and update on non-suicidal self-injury: who, how and why? Actas Esp Psiquiatr. 2018 Jul;46(4):146-55. Epub 2018 Jul 1.
PubMed 30079928
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 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 Effectiveness of Naltrexone in Improving Nonsuicidal Self-Injurious Behavior
- ClinicalTrials.gov ID
- NCT07641283
- Acronym / sponsor ID
- 2024-0057
- Conditions
- Nonsuicidal Self-Injury, Self-Injurious Behavior
- Keywords
- Nonsuicidal self-injury, NSSI, Self-injurious behavior, Naltrexone, Opioid antagonist, Impulsivity, Suicidal ideation, Ecological momentary assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Asan Medical Center, Uijeongbu Eulji University Hospital
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 11 Jun 2026 (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.
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.
Detailed description
Nonsuicidal self-injury is defined as the intentional destruction of one's own body tissue without suicidal intent. It is clinically important because it is associated with emotional dysregulation, impulsivity, psychiatric comorbidity, and increased risk of future suicidal behavior. However, evidence-based pharmacological treatments specifically targeting nonsuicidal self-injurious behavior remain limited.
Naltrexone is an opioid receptor antagonist that has been suggested to reduce repetitive self-injurious behaviors by modulating endogenous opioid-related reinforcement mechanisms. This study will investigate whether naltrexone is effective in reducing nonsuicidal self-injurious behavior in a randomized, double-blinded, placebo-controlled design.
A total of 150 participants will be enrolled across multiple study sites. Eligible participants will be randomly assigned in a 1:1 ratio to either the naltrexone group or the placebo group. The intervention period will last 6 weeks, with clinical evaluations conducted at baseline and every 2 weeks thereafter. Smartphone-based ecological momentary assessment will also be used to monitor self-injurious urges, mood states, and related behavioral variables during the study period.
Safety will be assessed throughout the study through adverse event monitoring, assessment of suicidal ideation and behavior, laboratory testing, urine testing, and electrocardiography according to the study schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either naltrexone plus treatment as usual or placebo plus treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| Naltrexone Group | Experimental | Drug: Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)Participants will receive Naltrexone 50mg orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU). |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants will receive a matching placebo orally once daily for 6 weeks, in addition to their current Treatment as Usual (TAU). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must meet all of the following criteria:
Key exclusion criteria (14 listed)
- Participants meeting any of the following criteria will be excluded:
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 |
|---|---|---|
| Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)Pure opioid antagonist administered 50mg once daily. | Drug | Naltrexone Group |
| PlaceboMatching placebo indistinguishable from the active drug, administered once daily. | Drug | Placebo Group |
Primary outcome
Total Number of Nonsuicidal Self-Injury Episodes During the 6-Week Treatment Period
Time frame: Baseline to Week 6
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.
17 secondary outcomes
Change From Baseline in Modified Obsessive Compulsive Drinking Scale Adapted for Nonsuicidal Self-Injury Urges Total Score
Time frame: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Columbia-Suicide Severity Rating Scale Suicidal Ideation Severity Score
Time frame: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Clinical Global Impressions-Severity Score
Time frame: Baseline, Week 2, Week 4, and Week 6
Number of Event-Based Ecological Momentary Assessment Reports of Nonsuicidal Self-Injury Urges
Time frame: During the 6-week intervention period
Number of Event-Based Ecological Momentary Assessment Reports of Nonsuicidal Self-Injury Behavior
Time frame: During the 6-week intervention period
Percentage of Planned Investigational Product Doses Taken as Assessed by Pill Count
Time frame: Week 2, Week 4, and Week 6
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Baseline through Week 6
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Baseline and Week 6
Number of Participants With Clinically Significant Electrocardiogram Abnormalities
Time frame: Baseline and Week 6
Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score
Time frame: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Hamilton Rating Scale for Anxiety Total Score
Time frame: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Patient Health Questionnaire-9 Total Score
Time frame: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Generalized Anxiety Disorder-7 Total Score
Time frame: Baseline, Week 2, Week 4, and Week 6
Change From Baseline in Eating Disorder Examination-Questionnaire Global Score
Time frame: Baseline and Week 6
Clinical Global Impressions-Improvement Score
Time frame: Week 2, Week 4, and Week 6
Weekly Positive Affect Score as Assessed by the Positive and Negative Affect Schedule
Time frame: Weekly during the 6-week intervention period
Weekly Negative Affect Score as Assessed by the Positive and Negative Affect Schedule
Time frame: Weekly during the 6-week intervention period
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 11 Jun 2026.
- Results publication: PubMed 31078660Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
- Results publication: PubMed 3563494Bradburn NM, Rips LJ, Shevell SK. Answering autobiographical questions: the impact of memory and inference on surveys. Science. 1987 Apr 10;236(4798):157-61. doi: 10.1126/science.3563494.
- Results publication: PubMed 7200102Clark DM, Teasdale JD. Diurnal variation in clinical depression and accessibility of memories of positive and negative experiences. J Abnorm Psychol. 1982 Apr;91(2):87-95. doi: 10.1037//0021-843x.91.2.87. No abstract available.
- Results publication: PubMed 18509902Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
- Results publication: PubMed 8600226Sonne S, Rubey R, Brady K, Malcolm R, Morris T. Naltrexone treatment of self-injurious thoughts and behaviors. J Nerv Ment Dis. 1996 Mar;184(3):192-5. doi: 10.1097/00005053-199603000-00011. No abstract available.
- Results publication: PubMed 8889912Casner JA, Weinheimer B, Gualtieri CT. Naltrexone and self-injurious behavior: a retrospective population study. J Clin Psychopharmacol. 1996 Oct;16(5):389-94. doi: 10.1097/00004714-199610000-00008.
- Results publication: PubMed 8555746Buzan RD, Thomas M, Dubovsky SL, Treadway J. The use of opiate antagonists for recurrent self-injurious behavior. J Neuropsychiatry Clin Neurosci. 1995 Fall;7(4):437-44. doi: 10.1176/jnp.7.4.437.
- Results publication: PubMed 2158355Kars H, Broekema W, Glaudemans-van Gelderen I, Verhoeven WM, van Ree JM. Naltrexone attenuates self-injurious behavior in mentally retarded subjects. Biol Psychiatry. 1990 Apr 1;27(7):741-6. doi: 10.1016/0006-3223(90)90589-t.
- Results publication: PubMed 29926087McCauley E, Berk MS, Asarnow JR, Adrian M, Cohen J, Korslund K, Avina C, Hughes J, Harned M, Gallop R, Linehan MM. Efficacy of Dialectical Behavior Therapy for Adolescents at High Risk for Suicide: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Aug 1;75(8):777-785. doi: 10.1001/jamapsychiatry.2018.1109.
- Results publication: PubMed 25245352Mehlum L, Tormoen AJ, Ramberg M, Haga E, Diep LM, Laberg S, Larsson BS, Stanley BH, Miller AL, Sund AM, Groholt B. Dialectical behavior therapy for adolescents with repeated suicidal and self-harming behavior: a randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Oct;53(10):1082-91. doi: 10.1016/j.jaac.2014.07.003. Epub 2014 Jul 22.
- Results publication: PubMed 27401883Aboujaoude E, Salame WO. Naltrexone: A Pan-Addiction Treatment? CNS Drugs. 2016 Aug;30(8):719-33. doi: 10.1007/s40263-016-0373-0.
- Results publication: PubMed 23339875Bresin K, Gordon KH. Endogenous opioids and nonsuicidal self-injury: a mechanism of affect regulation. Neurosci Biobehav Rev. 2013 Mar;37(3):374-83. doi: 10.1016/j.neubiorev.2013.01.020. Epub 2013 Jan 20.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to privacy and ethical restrictions. De-identified data may be made available from the corresponding investigator upon reasonable request and with appropriate institutional approval.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexone 50mg (Whanin Naltrexone Tab. 50mg) in people with Nonsuicidal Self-Injury and Self-Injurious Behavior, run by Seoul National University Hospital at 3 sites 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 6 inclusion and 14 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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 Myeong-hyeon Mun, MD, Master's Degree (+821085171499, psalms139@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Nonsuicidal Self-Injury Episodes During the 6-Week Treatment Period (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07641283, which also lists 14 linked publications.
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 11 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.