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

NCT06622239 | Not Yet Recruiting Phase 2

• 1 other identifier: AYM-NiNsSIB
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nonsuicidal Self-Injury

Outcome Measures

Primary Outcomes (1)

• Frequency of nonsuicidal self-injurous behavior

  Total number of nonsuicidal self-injurous behavior during study period

  6 weeks

Secondary Outcomes (4)

• Deliberate Self-harm Inventory

  6 weeks

• Clinical Global Impressions

  6 weeks

• Obsessive Compulsive Drinking Scale

  6 weeks

• Eating Disorder Examination-Questionnaire

  6 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

naltrexone 50mg

Drug: Naltrexone

comparison group

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Naltrexone DRUG

naltrexone 50mg for 6 weeks

Also known as: Revia

experimental group

Placebo DRUG

placebo for 6 weeks

comparison group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Whanin Pharmaceutical Company: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Yong Min Ahn, M.D, Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dae Hun Kang, M.D

CONTACT

82 + 02-2072-2457; redlinnet@daum.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: October 2, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

KR (1)