Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone

NCT03751111 | Completed Phase 1 Results DMC

• 1 other identifier: 2018/NAL/CSU/PRU
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pruritus

Keywords

arsenic exposure; naloxone; placebo; single-blind randomized trial

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale for Itch

  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.

  1 week

Secondary Outcomes (3)

• Pittsburgh Sleep Quality Index (PSQI)

  1 week

• Serological Indicator

  1 week

• Dermatology Life Quality Index (DLQI)

  1 week

Study Arms (2)

Naloxone

EXPERIMENTAL

Naloxone at an sublingual dose of 0.4 mg daily will be given to each subject.

Drug: Naloxone

Placebo

PLACEBO COMPARATOR

Sublingual placebo will be given to each subject.

Drug: Placebo

Interventions

Naloxone DRUG

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.

Naloxone

Placebo DRUG

Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, 410008, China

Location

Related Publications (1)

• Xiao Y, Huang X, Jing D, Huang Y, Zhang X, Shu Z, Huang Z, Su J, Li J, Zhang J, Chen M, Chen X, Shen M. Assessment of the Dermatology Life Quality Index (DLQI) in a homogeneous population under lifetime arsenic exposure. Qual Life Res. 2018 Dec;27(12):3209-3215. doi: 10.1007/s11136-018-1969-2. Epub 2018 Sep 10.

  PMID: 30203303 BACKGROUND

MeSH Terms

Interventions

Naloxone

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Minxue Shen
• Organization: Xiangya Hospital, Central South University

shenmx1988@csu.edu.cn

86-15973164022

Study Officials

• Yi Xiao, Ph.D

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Minxue Shen, Ph.D

  Xiangya Hospital of Central South University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to two arms using a computer-generalized sequence of random numbers.

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 23, 2018
• Study Start: February 13, 2019
• Primary Completion: March 1, 2019
• Study Completion: March 30, 2019
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Since the official start of the trial to the end of the trial
• Access Criteria: Describe clearly about the reason of review

Locations

CN (1)