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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
126
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 will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.
Xiangya Hospital
Changsha, Hunan, China
Numeric Rating Scale for Itch
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.
Time frame: 1 week
Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: 1 week
Serological Indicator
Level of serum beta-endorphin will be tested at baseline and week 1 of the trial
Time frame: 1 week
Dermatology Life Quality Index (DLQI)
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).
Time frame: 1 week
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