Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone: A Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale for Itch
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of sublingual naloxone in the treatment of chronic itch in patients under arsenic exposure.
详细描述
This study aims to determine the efficacy and safety of sublingual naloxone in the treatment of chronic, refractory itch in patients under long-term arsenic exposure. In this study, 120 subjects with a moderate-to-severe symptom of itching (numeric rating scale, NRS≥3) will be recruited and randomly treated with either sublingual naloxone (60 subjects) or placebo (60 subjects). The severity of itching will be evaluated in the wash out phase, baseline, and one week after the treatment through reporting of subjective symptomatology (itch NRS) via the interview. Quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI) and Dermatology Life Quality Index (DLQI) will serve as the secondary outcome.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participants will not be informed whether the drug they received is naloxone or placebo. The investigators will remove the package of the drugs and use the unified package for both of the drugs.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or over and without diseases except arsenic-related pruritus
- •Ability to study protocol and to give informed consent by himself/herself voluntarily
- •The number of male or female subjects is required more than 1/3 of the total number of subjects
- •Numeric Rating Sscale≥3 at the baseline
- •Subjects taking hormone-containing medications must be on a stable dose for 6 months prior to study start to avoid any confounding influence on sensory and pain perception
排除标准
- •Use of oral anti-inflammatory medications for 2 weeks prior to the study start.
- •Use of oral anti-histamines for 2 weeks prior to the study start.
- •Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start.
- •Use of oral neuromodulatory agents for 2 months prior to study start.
- •Current use of chronic pain medications (including opioids, antidepressants and anti-epileptic drugs).
- •Use of nicotine-containing products for the past 6 months prior to study start.
- •History of basic itchy dermatological diseases before such as eczema wich may influence the judgement of drug efficacy.
- •Unstable thyroid function within the past 6 months prior to study start to exclude thyroid-related neuropathy.
- •Known history of central or peripheral nervous system dysfunction.
- •History of acute hepatitis, chronic liver disease or end stage liver disease.
- •History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
- •History of neuropathy associated with chronic obstructive pulmonary disease, diabetes mellitus, documented exposure to organophosphates or heavy metals or polychlorinated biphenyls.
- •Known nutritional deficiency (vitamin B12, vitamin D, iron or zinc) within 3 months prior to the study start.
- •Use of illicit drugs within the past 6 months prior to study start.
- •Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of antineoplastic chemotherapeutic agents.
- •Patients considered by researchers that are not suitable to the study.
研究组 & 干预措施
Naloxone
Naloxone at an sublingual dose of 0.4 mg daily will be given to each subject.
干预措施: Naloxone (Drug)
Placebo
Sublingual placebo will be given to each subject.
干预措施: Placebo (Drug)
结局指标
主要结局
Numeric Rating Scale for Itch
时间窗: 1 week
Participants will be invited to report the severity of itch using the Numeric Rating Scale (NRS) for Itch at the baseline and week 1 of the trial. Numeric Rating Scale (NRS) for Itch is a self-reported scale to measure the intensity of itch, with a range of score from 0 to 10. Higher scores indicate stronger itching, with a score of 1 or 2 suggesting mild itching, a score between 3 and 6 suggesting moderate itching, and a greater than 7 indicating severe itching.
次要结局
- Pittsburgh Sleep Quality Index (PSQI)(1 week)
- Serological Indicator(1 week)
- Dermatology Life Quality Index (DLQI)(1 week)
研究者
Minxue Shen
Professor
Xiangya Hospital of Central South University