NCT03751111

Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone

Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone: A Double-blind Randomized Controlled Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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, 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.

Conditions

• Chronic Pruritus

Interventions

Type	Name	Description
DRUG	Naloxone	Naloxone at an sublingual dose of 0.4 mg daily for one week will be given to each subject. Subjects will self-administer the drug at supervision in the primary care center.
DRUG	Placebo	Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.

Timeline

• Start date: 2019-02-13
• Primary completion: 2019-03-01
• Completion: 2019-03-30
• First posted: 2018-11-23
• Last updated: 2025-04-20
• Results posted: 2025-04-20

Locations

1 site across 1 country: China