A Randomized, Double-Blinded Clinical Trial to Evaluate the Effects of Naltrexone in Improving Nonsuicidal Self-injurious Behavior
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Frequency of nonsuicidal self-injurous behavior
研究概览
简要总结
The goal of this clinical trial is to learn if naltrexone works to treat nonsuicidal self-injurious behavior in adolescents and adults.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
experimental group
naltrexone 50mg
干预措施: Naltrexone (Drug)
comparison group
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of nonsuicidal self-injurous behavior
时间窗: 6 weeks
Total number of nonsuicidal self-injurous behavior during study period
次要结局
- Clinical Global Impressions(6 weeks)
- Obsessive Compulsive Drinking Scale(6 weeks)
- Eating Disorder Examination-Questionnaire(6 weeks)
- Deliberate Self-harm Inventory(6 weeks)
研究者
Yong Min Ahn
Professor
Seoul National University Hospital