xml: <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/NCT05971043</url>
    </required_header>
    <id_info>
      <org_study_id>meth addiction</org_study_id>
      <nct_id>NCT05971043</nct_id>
    </id_info>
    <brief_title>Skin Disease in Methamphetamine Abuse</brief_title>
    <official_title>Skin Disorders in Patients Using Methamphetamine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        1. To detect the skin diseases in patients using methamphetamine&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Methamphetamine is a stimulant drug that associated with a broad spectrum of health&#xD;
        conditions, include addiction, mental health disorders, and overdose. The Drug Enforcement&#xD;
        Agency (DEA) classifies it as a Schedule II drug. This means that the drug has a high&#xD;
        potential for misuse. The drug is also called crystal meth, ice, and blue.&#xD;
  &#xD;
        Methamphetamine use has increased in Egypt especially in upper Egypt. Literature on cutaneous&#xD;
        manifestations among methamphetamine users is limited, although cellulitis, delusion of&#xD;
        parasitosis (DOP), hyperhidrosis, formication and prurigo nodularis (PN) have been attributed&#xD;
        to methamphetamine users. While the relationship between skin lesions and substance use in&#xD;
        not fully defined, there is some evidence that points to the development of these itchy, red&#xD;
        lesion also known as meth sore after meth use. Meth sores often look like small round red&#xD;
        patches on your skin, they can often be confused with acne when they appear on the face or a&#xD;
        rash when they appear on other parts of the body.&#xD;
  &#xD;
        Meth sores form as a result of heavy meth misuse. other signs of meth abuse at the stage&#xD;
        where sores likely to develop include:&#xD;
  &#xD;
          -  Weight loss&#xD;
  &#xD;
          -  Paranoia&#xD;
  &#xD;
          -  Hallucinations&#xD;
  &#xD;
          -  Aggressive behavior&#xD;
  &#xD;
          -  Being easily distracted&#xD;
  &#xD;
          -  Tooth and gum decay&#xD;
  &#xD;
          -  Changes in brain structure&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 3, 2023</start_date>
    <completion_date type="Anticipated">September 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 20, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>skin disorders in patients using methamphetamine</measure>
      <time_frame>baseline</time_frame>
      <description>questionnaire-based study To detect the skin diseases and manifestation appears in patients using methamphetamine</description>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Methamphetamine Abuse</condition>
    <eligibility>
      <study_pop>
        <textblock>
          cross-sectional, questionnaire-based, study including clinical assessment of diseases&#xD;
          severity.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients using methamphetamine&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Pregnant and lactating patients. 2. Patients with chronic diseases&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Ahmed Shawkey gomaa, Lecturer</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>asmaa mohamed, master</last_name>
      <phone>+201097507017</phone>
      <email>amelnakeeb@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>sahar ismail, professor</last_name>
      <phone>01008899446</phone>
      <email>saharsotohy@yahoo.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Barnes AJ, Smith ML, Kacinko SL, Schwilke EW, Cone EJ, Moolchan ET, Huestis MA. Excretion of methamphetamine and amphetamine in human sweat following controlled oral methamphetamine administration. Clin Chem. 2008 Jan;54(1):172-80. doi: 10.1373/clinchem.2007.092304. Epub 2007 Nov 2.</citation>
      <PMID>17981924</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 9, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Asmaa mohamed hafez</investigator_full_name>
      <investigator_title>principal investigator Dr asmaa mohamed hafez</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971043
  org study id: meth addiction
  nct id: NCT05971043
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  1. To detect the skin diseases in patients using methamphetamine
  Methamphetamine is a stimulant drug that associated with a broad spectrum of health
        conditions, include addiction, mental health disorders, and overdose. The Drug Enforcement
        Agency (DEA) classifies it as a Schedule II drug. This means that the drug has a high
        potential for misuse. The drug is also called crystal meth, ice, and blue.
  
        Methamphetamine use has increased in Egypt especially in upper Egypt. Literature on cutaneous
        manifestations among methamphetamine users is limited, although cellulitis, delusion of
        parasitosis (DOP), hyperhidrosis, formication and prurigo nodularis (PN) have been attributed
        to methamphetamine users. While the relationship between skin lesions and substance use in
        not fully defined, there is some evidence that points to the development of these itchy, red
        lesion also known as meth sore after meth use. Meth sores often look like small round red
        patches on your skin, they can often be confused with acne when they appear on the face or a
        rash when they appear on other parts of the body.
  
        Meth sores form as a result of heavy meth misuse. other signs of meth abuse at the stage
        where sores likely to develop include:
  
          -  Weight loss
  
          -  Paranoia
  
          -  Hallucinations
  
          -  Aggressive behavior
  
          -  Being easily distracted
  
          -  Tooth and gum decay
  
          -  Changes in brain structure
  observational model: Case-Only
  time perspective: Prospective
  measure: skin disorders in patients using methamphetamine
  time frame: baseline
  description: questionnaire-based study To detect the skin diseases and manifestation appears in patients using methamphetamine
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 75 Years
  last name: Ahmed Shawkey gomaa, Lecturer
  role: Study Director
  affiliation: Assiut University
  last name: asmaa mohamed, master
  phone: +201097507017
  email: amelnakeeb@gmail.com
  last name: sahar ismail, professor
  phone: 01008899446
  email: saharsotohy@yahoo.com
  citation: Barnes AJ, Smith ML, Kacinko SL, Schwilke EW, Cone EJ, Moolchan ET, Huestis MA. Excretion of methamphetamine and amphetamine in human sweat following controlled oral methamphetamine administration. Clin Chem. 2008 Jan;54(1):172-80. doi: 10.1373/clinchem.2007.092304. Epub 2007 Nov 2.
  PMID: 17981924
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Asmaa mohamed hafez
  investigator title: principal investigator Dr asmaa mohamed hafez
  sharing ipd: No