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

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

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 Overview

• Status: Completed
• Conditions: Chronic Pruritus
• Intervention / Treatment: Drug: Naloxone; Drug: Placebo

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, 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 18 years or over and without diseases except arsenic-related pruritus
2. Ability to study protocol and to give informed consent by himself/herself voluntarily
3. The number of male or female subjects is required more than 1/3 of the total number of subjects
4. Hair arsenic concentration≥1 μg/g
5. Numeric Rating Sscale≥3 at the baseline
6. 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:

1. Use of oral anti-inflammatory medications for 2 weeks prior to the study start.
2. Use of oral anti-histamines for 2 weeks prior to the study start.
3. Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start.
4. Use of oral neuromodulatory agents for 2 months prior to study start.
5. Current use of chronic pain medications (including opioids, antidepressants and anti-epileptic drugs).
6. Use of nicotine-containing products for the past 6 months prior to study start.
7. History of basic itchy dermatological diseases before such as eczema wich may influence the judgement of drug efficacy.
8. Unstable thyroid function within the past 6 months prior to study start to exclude thyroid-related neuropathy.
9. Known history of central or peripheral nervous system dysfunction.
10. History of acute hepatitis, chronic liver disease or end stage liver disease.
11. History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
12. History of neuropathy associated with chronic obstructive pulmonary disease, diabetes mellitus, documented exposure to organophosphates or heavy metals or polychlorinated biphenyls.
13. Known nutritional deficiency (vitamin B12, vitamin D, iron or zinc) within 3 months prior to the study start.
14. Use of illicit drugs within the past 6 months prior to study start.
15. Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of antineoplastic chemotherapeutic agents.
16. Patients considered by researchers that are not suitable to the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naloxone; Naloxone at an sublingual dose of 40 mg daily will be given to each subject.	Drug: Naloxone; Naloxone at an sublingual dose of 40 mg daily for one week will be given to each subject. Subjects will self-administer the drug at supervision in the primary care center.
Placebo Comparator: Placebo; Sublingual placebo will be given to each subject.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in symptom of itch	Participants will be asked to report the severity of itch using a numeric rating scale (NRS) at the baseline and week 1 of the trial	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleeping quality	Measured by the Pittsburgh Sleep Quality Index at baseline and week 1 of the trial	1 week
Serological indicator	Level of serum beta-endorphin will be tested at baseline and week 1 of the trial	1 week
Health-related quality of life	Dermatology Life Quality Index (DLQI) at baseline and week 1 of the trial	1 week

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Investigators: Principal Investigator: Yi Xiao, Ph.D, Xiangya Hospital of Central South University; Study Director: Minxue Shen, Ph.D, Xiangya Hospital of Central South University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: placebo; naloxone; arsenic exposure; single-blind randomized trial
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Naloxone
• Other Study ID Numbers: 2018/NAL/CSU/PRU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF) can be shared for the purpose of academic communication
• IPD Sharing Time Frame: Since the official start of the trial to the end of the trial
• IPD Sharing Access Criteria: Describe clearly about the reason of review
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No