Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone

Chronic Pruritus Clinical Trial

Official title: Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone: A Single-blind Randomized Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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, 200 subjects with a moderate-to-severe symptom of itching (numeric rating scale, NRS≥3) will be recruited and randomly treated with either sublingual naloxone (100 subjects) or placebo (100 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. ;

Related Conditions & MeSH terms

• Chronic Pruritus
• Pruritus

• NCT number: NCT03751111
• Study type: Interventional
• Source: Xiangya Hospital of Central South University
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 13, 2019
• Completion date: March 30, 2019