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

Primary Purpose

Chronic Pruritus

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Naloxone

Placebo

About this trial

This is an interventional treatment trial for Chronic Pruritus focused on measuring arsenic exposure, naloxone, placebo, single-blind randomized trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
Hair arsenic concentration≥1 μg/g
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.

Sites / Locations

Xiangya Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Naloxone

Placebo

Arm Description

Naloxone at an sublingual dose of 40 mg daily will be given to each subject.

Sublingual placebo will be given to each subject.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sleeping quality

Measured by the Pittsburgh Sleep Quality Index at baseline and week 1 of the trial

Serological indicator

Level of serum beta-endorphin will be tested at baseline and week 1 of the trial

Health-related quality of life

Dermatology Life Quality Index (DLQI) at baseline and week 1 of the trial

Full Information

NCT ID

NCT03751111

First Posted

November 21, 2018

Last Updated

April 9, 2019

Sponsor

Xiangya Hospital of Central South University

1. Study Identification

Unique Protocol Identification Number

NCT03751111

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

February 13, 2019 (Actual)

Primary Completion Date

March 1, 2019 (Actual)

Study Completion Date

March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pruritus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Participant

Masking Description

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.

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Naloxone

Arm Type

Experimental

Arm Description

Naloxone at an sublingual dose of 40 mg daily will be given to each subject.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Sublingual placebo will be given to each subject.

Intervention Type

Drug

Intervention Name(s)

Naloxone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Reduction in symptom of itch

Description

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

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Sleeping quality

Description

Measured by the Pittsburgh Sleep Quality Index at baseline and week 1 of the trial

Time Frame

1 week

Title

Serological indicator

Description

Level of serum beta-endorphin will be tested at baseline and week 1 of the trial

Time Frame

1 week

Title

Health-related quality of life

Description

Dermatology Life Quality Index (DLQI) at baseline and week 1 of the trial

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 Hair arsenic concentration≥1 μg/g 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Xiao, Ph.D

Organizational Affiliation

Xiangya Hospital of Central South University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Minxue Shen, Ph.D

Organizational Affiliation

Xiangya Hospital of Central South University

Official's Role

Study Director

Facility Information:

Facility Name

Xiangya Hospital

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

30203303

Citation

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.

Results Reference

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

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