Phase 2
Completed N=126
Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone
Source: ClinicalTrials.gov NCT03751111 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Numeric Rating Scale for Itch — 6.42; 7.8 score on a scale (0~10)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale for Itch |
6.42; 7.8 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
9.5; 10.0 | — |
| SECONDARY Serological Indicator |
— | — |
| SECONDARY Dermatology Life Quality Index (DLQI) |
9.2; 12.1 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03751111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.