Chronic PruritusPhase 1/2NCT03751111
Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone
A Phase 1/2 study testing Naloxone in people with Chronic Pruritus, run by Xiangya Hospital of Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pruritus
- What is being tested?
- Naloxone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2019to 30 Mar 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or over and without diseases except arsenic-related pruritus
- Ability to study protocol and to give informed consent by himself/herself voluntarily
- The number of male or female subjects is required more than 1/3 of the total number of subjects
- Numeric Rating Sscale≥3 at the baseline
- 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
Who cannot join
- Use of oral anti-inflammatory medications for 2 weeks prior to the study start.
- Use of oral anti-histamines for 2 weeks prior to the study start.
- Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start.
- Use of oral neuromodulatory agents for 2 months prior to study start.
- Current use of chronic pain medications (including opioids, antidepressants and anti-epileptic drugs).
- Use of nicotine-containing products for the past 6 months prior to study start.
Show all 16Show fewer
- History of basic itchy dermatological diseases before such as eczema wich may influence the judgement of drug efficacy.
- Unstable thyroid function within the past 6 months prior to study start to exclude thyroid-related neuropathy.
- Known history of central or peripheral nervous system dysfunction.
- History of acute hepatitis, chronic liver disease or end stage liver disease.
- History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
- History of neuropathy associated with chronic obstructive pulmonary disease, diabetes mellitus, documented exposure to organophosphates or heavy metals or polychlorinated biphenyls.
- Known nutritional deficiency (vitamin B12, vitamin D, iron or zinc) within 3 months prior to the study start.
- Use of illicit drugs within the past 6 months prior to study start.
- Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of antineoplastic chemotherapeutic agents.
- Patients considered by researchers that are not suitable to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone: A Double-blind Randomized Controlled Trial
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.
Read the 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, 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
- Chronic Pruritus
- Being tested
- Naloxone, Placebo
- Keywords
- arsenic exposure, naloxone, placebo, single-blind randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaloxoneDrug
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.
PlaceboDrug
Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.
| Study group | Role | What they receive |
|---|---|---|
| Naloxone | Experimental | Naloxone at an sublingual dose of 0.4 mg daily will be given to each subject. Receives: Drug: Naloxone |
| Placebo | Placebo comparator | Sublingual placebo will be given to each subject. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (3)
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.
Measured: 1 week
Serological Indicator
Level of serum beta-endorphin will be tested at baseline and week 1 of the trial
Measured: 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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start13 Feb 2019
- Primary completion1 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PruritusStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to two arms using a computer-generalized sequence of random numbers.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minxue Shen, Xiangya Hospital of Central South University
- Investigators
- Yi Xiao, Ph.D, Principal investigator, Xiangya Hospital of Central South UniversityMinxue Shen, Ph.D, Study director, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751111
- Sponsor's protocol ID
- 2018/NAL/CSU/PRU
- Status last verified
- Apr 2025
- First submitted
- 21 Nov 2018
- Last updated
- 20 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF) can be shared for the purpose of academic communication
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.
PubMed 30203303
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone: A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03751111
- Acronym / sponsor ID
- 2018/NAL/CSU/PRU
- Conditions
- Chronic Pruritus
- Keywords
- arsenic exposure, naloxone, placebo, single-blind randomized trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two arms using a computer-generalized sequence of random numbers.
| Arm | Type | Receives |
|---|---|---|
| Naloxone | Experimental | Drug: NaloxoneNaloxone at an sublingual dose of 0.4 mg daily will be given to each subject. |
| Placebo | Placebo comparator | Drug: PlaceboSublingual placebo will be given to each subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or over and without diseases except arsenic-related pruritus
- Ability to study protocol and to give informed consent by himself/herself voluntarily
- The number of male or female subjects is required more than 1/3 of the total number of subjects
- Numeric Rating Sscale≥3 at the baseline
- 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
Key exclusion criteria (16 listed)
- Use of oral anti-inflammatory medications for 2 weeks prior to the study start.
- Use of oral anti-histamines for 2 weeks prior to the study start.
- Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start.
- Use of oral neuromodulatory agents for 2 months prior to study start.
- Current use of chronic pain medications (including opioids, antidepressants and anti-epileptic drugs).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaloxoneNaloxone 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. | Drug | Naloxone |
| PlaceboPlacebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center. | Drug | Placebo |
Primary outcome
Numeric Rating Scale for Itch
Time frame: 1 week
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.
3 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 week
Serological Indicator
Time frame: 1 week
Dermatology Life Quality Index (DLQI)
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30203303Xiao 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.
- Individual participant dataSharing planned: Yes. Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF) can be shared for the purpose of academic communication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Xiao, Ph.D principal investigator
Xiangya Hospital of Central South University
Minxue Shen, Ph.D study director
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Naloxone in people with Chronic Pruritus, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale for Itch (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03751111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.