Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-13

Study Completion Date

2019-03-30

Brief Summary

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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.

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Detailed Description

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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, 120 subjects with a moderate-to-severe symptom of itching (numeric rating scale, NRS≥3) will be recruited and randomly treated with either sublingual naloxone (60 subjects) or placebo (60 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.

Conditions

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Chronic Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Naloxone

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

Group Type EXPERIMENTAL

Naloxone

Intervention Type 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.

Placebo

Sublingual placebo will be given to each subject.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Naloxone

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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. Numeric Rating Sscale≥3 at the baseline
5. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No