At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 126 enrolled
Drug / intervention
Naloxone +1 moredrug
Likely dose
Naloxone 0.4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone: A Double-blind Randomized Controlled Trial
Xiangya Hospital of Central South University·interventional·Posted Nov 23, 2018·Updated Apr 20, 2025
In Brief
A Phase 2 clinical trial evaluating Naloxone and Placebo for Chronic Pruritus. Completed, enrolled 126 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pruritus
CountriesChina
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartFeb 2019
Primary CompletionMar 2019
Study CompletionMar 2019
TodayJul 2026
First PostedNov 23, 2018
Enrollment StartFeb 13, 2019
Primary CompletionMar 1, 2019
Study CompletionMar 30, 2019
TodayJul 2, 2026
Enrollment to primary: 18 daysPosted 7.6 years ago
Interventions
Naloxonedrug
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.
Placebodrug
Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.