<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03751111</url>
  </required_header>
  <id_info>
    <org_study_id>2018/NAL/CSU/PRU</org_study_id>
    <nct_id>NCT03751111</nct_id>
  </id_info>
  <brief_title>Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone</brief_title>
  <official_title>Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone: A Single-blind Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xiangya Hospital of Central South University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of sublingual naloxone in the&#xD;
      treatment of chronic itch in patients under arsenic exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to determine the efficacy and safety of sublingual naloxone in the treatment&#xD;
      of chronic, refractory itch in patients under long-term arsenic exposure. In this study, 200&#xD;
      subjects with a moderate-to-severe symptom of itching (numeric rating scale, NRS≥3) will be&#xD;
      recruited and randomly treated with either sublingual naloxone (100 subjects) or placebo (100&#xD;
      subjects). The severity of itching will be evaluated in the wash out phase, baseline, and one&#xD;
      week after the treatment through reporting of subjective symptomatology (itch NRS) via the&#xD;
      interview. Quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI) and&#xD;
      Dermatology Life Quality Index (DLQI) will serve as the secondary outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2019</start_date>
  <completion_date type="Actual">March 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be randomly assigned to two arms using a computer-generalized sequence of random numbers.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in symptom of itch</measure>
    <time_frame>1 week</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleeping quality</measure>
    <time_frame>1 week</time_frame>
    <description>Measured by the Pittsburgh Sleep Quality Index at baseline and week 1 of the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serological indicator</measure>
    <time_frame>1 week</time_frame>
    <description>Level of serum beta-endorphin will be tested at baseline and week 1 of the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>1 week</time_frame>
    <description>Dermatology Life Quality Index (DLQI) at baseline and week 1 of the trial</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Chronic Pruritus</condition>
  <arm_group>
    <arm_group_label>Naloxone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Naloxone at an sublingual dose of 40 mg daily will be given to each subject.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sublingual placebo will be given to each subject.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naloxone</intervention_name>
    <description>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.</description>
    <arm_group_label>Naloxone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18 years or over and without diseases except arsenic-related pruritus&#xD;
&#xD;
          2. Ability to study protocol and to give informed consent by himself/herself voluntarily&#xD;
&#xD;
          3. The number of male or female subjects is required more than 1/3 of the total number of&#xD;
             subjects&#xD;
&#xD;
          4. Hair arsenic concentration≥1 μg/g&#xD;
&#xD;
          5. Numeric Rating Sscale≥3 at the baseline&#xD;
&#xD;
          6. Subjects taking hormone-containing medications must be on a stable dose for 6 months&#xD;
             prior to study start to avoid any confounding influence on sensory and pain perception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of oral anti-inflammatory medications for 2 weeks prior to the study start.&#xD;
&#xD;
          2. Use of oral anti-histamines for 2 weeks prior to the study start.&#xD;
&#xD;
          3. Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start.&#xD;
&#xD;
          4. Use of oral neuromodulatory agents for 2 months prior to study start.&#xD;
&#xD;
          5. Current use of chronic pain medications (including opioids, antidepressants and&#xD;
             anti-epileptic drugs).&#xD;
&#xD;
          6. Use of nicotine-containing products for the past 6 months prior to study start.&#xD;
&#xD;
          7. History of basic itchy dermatological diseases before such as eczema wich may&#xD;
             influence the judgement of drug efficacy.&#xD;
&#xD;
          8. Unstable thyroid function within the past 6 months prior to study start to exclude&#xD;
             thyroid-related neuropathy.&#xD;
&#xD;
          9. Known history of central or peripheral nervous system dysfunction.&#xD;
&#xD;
         10. History of acute hepatitis, chronic liver disease or end stage liver disease.&#xD;
&#xD;
         11. History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.&#xD;
&#xD;
         12. History of neuropathy associated with chronic obstructive pulmonary disease, diabetes&#xD;
             mellitus, documented exposure to organophosphates or heavy metals or polychlorinated&#xD;
             biphenyls.&#xD;
&#xD;
         13. Known nutritional deficiency (vitamin B12, vitamin D, iron or zinc) within 3 months&#xD;
             prior to the study start.&#xD;
&#xD;
         14. Use of illicit drugs within the past 6 months prior to study start.&#xD;
&#xD;
         15. Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of&#xD;
             antineoplastic chemotherapeutic agents.&#xD;
&#xD;
         16. Patients considered by researchers that are not suitable to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi Xiao, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xiangya Hospital of Central South University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Minxue Shen, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Xiangya Hospital of Central South University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xiangya Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>30203303</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>April 9, 2019</last_update_submitted>
  <last_update_submitted_qc>April 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xiangya Hospital of Central South University</investigator_affiliation>
    <investigator_full_name>Minxue Shen</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>arsenic exposure</keyword>
  <keyword>naloxone</keyword>
  <keyword>placebo</keyword>
  <keyword>single-blind randomized trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naloxone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF) can be shared for the purpose of academic communication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Since the official start of the trial to the end of the trial</ipd_time_frame>
    <ipd_access_criteria>Describe clearly about the reason of review</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>January 23, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03751111
org study id: 2018/NAL/CSU/PRU
nct id: NCT03751111
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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, 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.
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.
primary purpose: Treatment
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.
measure: Reduction in symptom of itch
time frame: 1 week
description: 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
measure: Sleeping quality
time frame: 1 week
description: Measured by the Pittsburgh Sleep Quality Index at baseline and week 1 of the trial
measure: Serological indicator
time frame: 1 week
description: Level of serum beta-endorphin will be tested at baseline and week 1 of the trial
measure: Health-related quality of life
time frame: 1 week
description: Dermatology Life Quality Index (DLQI) at baseline and week 1 of the trial
arm group label: Naloxone
arm group type: Experimental
description: Naloxone at an sublingual dose of 40 mg daily will be given to each subject.
arm group label: Placebo
arm group type: Placebo Comparator
description: Sublingual placebo will be given to each subject.
intervention type: Drug
intervention name: Naloxone
description: 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.
arm group label: Naloxone
intervention type: Drug
intervention name: Placebo
description: Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yi Xiao, Ph.D
role: Principal Investigator
affiliation: Xiangya Hospital of Central South University
last name: Minxue Shen, Ph.D
role: Study Director
affiliation: Xiangya Hospital of Central South University
facility: 
country: China
citation: 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.
PMID: 30203303
responsible party type: Principal Investigator
investigator affiliation: Xiangya Hospital of Central South University
investigator full name: Minxue Shen
investigator title: Assistant professor
mesh term: Pruritus
mesh term: Naloxone
sharing ipd: Yes
ipd description: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF) can be shared for the purpose of academic communication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Since the official start of the trial to the end of the trial
ipd access criteria: Describe clearly about the reason of review
submitted: January 23, 2023