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

Sponsor

Xiangya Hospital of Central South University (Other)

Overall Status

Completed

CT.gov ID

NCT03751111

Collaborator

(none)

100

Enrollment

Location

Arms

1.5

Actual Duration (Months)

67.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pruritus	Drug: Naloxone Drug: Placebo	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 13, 2019

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Mar 30, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Reduction in symptom of itch [1 week]
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 [1 week]
Measured by the Pittsburgh Sleep Quality Index at baseline and week 1 of the trial
Serological indicator [1 week]
Level of serum beta-endorphin will be tested at baseline and week 1 of the trial
Health-related quality of life [1 week]
Dermatology Life Quality Index (DLQI) at baseline and week 1 of the trial

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiangya Hospital	Changsha	Hunan	China	410008

Sponsors and Collaborators

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