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

Chronic Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03751111
• Other study ID #: 2018/NAL/CSU/PRU
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 13, 2019
• Est. completion date: March 30, 2019

Study information

• Verified date: April 2019
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 30, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pruritus
• Pruritus

Intervention

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

Locations

Country	Name	City	State
China	Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

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