Trial Outcomes & Findings for Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone (NCT NCT03751111)

Results Overview

Participants will be invited to report the severity of itch using the Numeric Rating Scale (NRS) for Itch at the baseline and week 1 of the trial. Numeric Rating Scale (NRS) for Itch is a self-reported scale to measure the intensity of itch, with a range of score from 0 to 10. Higher scores indicate stronger itching, with a score of 1 or 2 suggesting mild itching, a score between 3 and 6 suggesting moderate itching, and a greater than 7 indicating severe itching.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

126 participants

Primary outcome timeframe

1 week

Results posted on

2025-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Naloxone Naloxone at an sublingual dose of 0.4 mg daily will be given to each subject. 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.	Placebo Sublingual placebo will be given to each subject. Placebo: Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.
Overall Study STARTED	62	64
Overall Study COMPLETED	50	32
Overall Study NOT COMPLETED	12	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Naloxone Naloxone at an sublingual dose of 0.4 mg daily will be given to each subject. 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.	Placebo Sublingual placebo will be given to each subject. Placebo: Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.
Overall Study Lack of Efficacy	9	30
Overall Study Adverse Event	3	2

Baseline Characteristics

Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naloxone n=62 Participants Naloxone at an sublingual dose of 0.4 mg daily will be given to each subject. 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.	Placebo n=64 Participants Sublingual placebo will be given to each subject. Placebo: Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.	Total n=126 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 9 • n=93 Participants	60 years STANDARD_DEVIATION 9 • n=4 Participants	59 years STANDARD_DEVIATION 9 • n=27 Participants
Sex: Female, Male Female	27 Participants n=93 Participants	26 Participants n=4 Participants	53 Participants n=27 Participants
Sex: Female, Male Male	35 Participants n=93 Participants	38 Participants n=4 Participants	73 Participants n=27 Participants
Race/Ethnicity, Customized Chinese	62 Participants n=93 Participants	64 Participants n=4 Participants	126 Participants n=27 Participants
Region of Enrollment China	62 participants n=93 Participants	64 participants n=4 Participants	126 participants n=27 Participants
Numeric Rating Scale for Itch	8.18 units on a scale STANDARD_DEVIATION 1.77 • n=93 Participants	8.58 units on a scale STANDARD_DEVIATION 1.56 • n=4 Participants	8.38 units on a scale STANDARD_DEVIATION 1.66 • n=27 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Intention-to-treat population

Participants will be invited to report the severity of itch using the Numeric Rating Scale (NRS) for Itch at the baseline and week 1 of the trial. Numeric Rating Scale (NRS) for Itch is a self-reported scale to measure the intensity of itch, with a range of score from 0 to 10. Higher scores indicate stronger itching, with a score of 1 or 2 suggesting mild itching, a score between 3 and 6 suggesting moderate itching, and a greater than 7 indicating severe itching.

Outcome measures

Outcome measures
Measure	Naloxone n=62 Participants Naloxone at an sublingual dose of 0.4 mg daily will be given to each subject. 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.	Placebo n=64 Participants Sublingual placebo will be given to each subject. Placebo: Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.
Numeric Rating Scale for Itch	6.42 score on a scale (0~10) Standard Deviation 2.15	7.8 score on a scale (0~10) Standard Deviation 1.99

SECONDARY outcome

Timeframe: 1 week

Measured by the Pittsburgh Sleep Quality Index (PSQI) at baseline and week 1 of the trial. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.

Outcome measures

Outcome measures
Measure	Naloxone n=62 Participants Naloxone at an sublingual dose of 0.4 mg daily will be given to each subject. 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.	Placebo n=64 Participants Sublingual placebo will be given to each subject. Placebo: Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.
Pittsburgh Sleep Quality Index (PSQI)	9.5 units on a scale (0-21) Interval 5.0 to 13.0	10.0 units on a scale (0-21) Interval 6.0 to 12.5

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 week

Dermatology Life Quality Index (DLQI) at baseline and week 1 of the trial. It consists of ten questions which ask about symptoms, feelings, daily activities, leisure, work, school, personal relationships, and treatment. Every question asked relates to the previous week. The user can tick a box in either: 'not at all', 'a little', 'a lot' or 'very much'. Questions are scored from 0 to 3 and totalled, giving an overall score out of 30. The final score ranges from 0 (no impact on quality of life) to 30 (maximum impairment).

Outcome measures

Outcome measures
Measure	Naloxone n=62 Participants Naloxone at an sublingual dose of 0.4 mg daily will be given to each subject. 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.	Placebo n=64 Participants Sublingual placebo will be given to each subject. Placebo: Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.
Dermatology Life Quality Index (DLQI)	9.2 units on a scale (0-30) Standard Deviation 6.7	12.1 units on a scale (0-30) Standard Deviation 6.2

Adverse Events

Naloxone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Naloxone n=62 participants at risk Naloxone at an sublingual dose of 0.4 mg daily will be given to each subject. 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.	Placebo n=64 participants at risk Sublingual placebo will be given to each subject. Placebo: Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.
Respiratory, thoracic and mediastinal disorders Cold	1.6% 1/62 • Number of events 1 • 2 weeks	1.6% 1/64 • Number of events 1 • 2 weeks
Nervous system disorders Headache	3.2% 2/62 • Number of events 2 • 2 weeks	1.6% 1/64 • Number of events 1 • 2 weeks

Additional Information

Dr. Minxue Shen

Xiangya Hospital, Central South University

Phone: 86-15973164022

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place