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

• ClinicalTrials.gov Identifier: NCT03751111
• Recruitment Status: Completed
• First Posted: November 23, 2018
• Last Update Posted: April 11, 2019
• Sponsor: Xiangya Hospital of Central South University
• Information provided by (Responsible Party): Minxue Shen, Xiangya Hospital of Central South University

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 (Clinical Trial)
• 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.
• 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: February 13, 2019
• Actual Primary Completion Date: March 1, 2019
• Actual Study Completion Date: March 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.

Outcome Measures

Primary Outcome Measures :

1. Reduction in symptom of itch [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China, Hunan

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

More Information

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.

• Responsible Party: Minxue Shen, Assistant professor, Xiangya Hospital of Central South University
• ClinicalTrials.gov Identifier: NCT03751111
• Other Study ID Numbers: 2018/NAL/CSU/PRU
• First Posted: November 23, 2018
• Last Update Posted: April 11, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

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

• 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

Keywords provided by Minxue Shen, Xiangya Hospital of Central South University:

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

Additional relevant MeSH terms:

Pruritus; Skin Diseases; Skin Manifestations; Naloxone; Narcotic Antagonists; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents