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/NCT06014164</url>
    </required_header>
    <id_info>
      <org_study_id>RC31/23/0396</org_study_id>
      <secondary_id>2023-A01575-40</secondary_id>
      <nct_id>NCT06014164</nct_id>
    </id_info>
    <brief_title>Qualitative Study About Psychedelics Using in Psychiatric Disorders</brief_title>
    <acronym>PSYCHEQUALI</acronym>
    <official_title>Qualitative Study of the Self-administered Therapeutic Use of Psychedelics in People With Psychiatric Disorders</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Toulouse</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is set up to better understand the current use of psychedelics in France in the&#xD;
        general population. We focus on individuals who have used any type of psychedelic drug in&#xD;
        order to suppress or alleviate a psychiatric symptom in the context of a diagnosed pathology.&#xD;
        The data are collected during a semi-structured interview and then studied in a thematic&#xD;
        analysis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">March 10, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 10, 2025</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>Experiences of people using psychedelic substances</measure>
      <time_frame>Baseline</time_frame>
      <description>The experiences of people with psychiatric disorders who use psychedelic substances for therapeutic purposes will be assessed by interview</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Profile of people using psychedelic substances</measure>
      <time_frame>Baseline</time_frame>
      <description>The profile of people with psychiatric disorders who use psychedelic substances for therapeutic purposes will be assessed by interview</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Psychiatric Disorder</condition>
    <arm_group>
      <arm_group_label>Patients using psychedelic substances</arm_group_label>
      <description>Adult patients self-administering psychedelic substances in psychiatric disorders</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Interview</intervention_name>
      <description>An interview will be conducted to describe the experiences of people with psychiatric disorders who use psychedelic substances for therapeutic purposes</description>
      <arm_group_label>Patients using psychedelic substances</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults patients self-administering psychodelic substances for therapeutic purposes&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with a psychiatric disorder by a psychiatrist or general&#xD;
               practitioner&#xD;
  &#xD;
            -  Patients used psychedelic or related substances in order to treat psychiatric symptoms&#xD;
  &#xD;
            -  Adults patients (&gt;18 years old)&#xD;
  &#xD;
            -  Patients have given their oral non-opposition&#xD;
  &#xD;
            -  Patients affiliated to a social security scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who don't speak or understand French&#xD;
  &#xD;
            -  Patients under protection, guardianship or curators&#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>Antoine YRONDI, PH</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Toulouse</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Antoine YRONDI, PH</last_name>
      <phone>0561778603</phone>
      <email>yrondi.a@chu-toulouse.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Paul ROCHEFORT</last_name>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Psychiatric disorder</keyword>
    <keyword>Psychedelics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Problem Behavior</mesh_term>
    </condition_browse>
    <!-- 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/NCT06014164
  org study id: RC31/23/0396
  secondary id: 2023-A01575-40
  nct id: NCT06014164
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is set up to better understand the current use of psychedelics in France in the
        general population. We focus on individuals who have used any type of psychedelic drug in
        order to suppress or alleviate a psychiatric symptom in the context of a diagnosed pathology.
        The data are collected during a semi-structured interview and then studied in a thematic
        analysis.
  observational model: Case-Only
  time perspective: Prospective
  measure: Experiences of people using psychedelic substances
  time frame: Baseline
  description: The experiences of people with psychiatric disorders who use psychedelic substances for therapeutic purposes will be assessed by interview
  measure: Profile of people using psychedelic substances
  time frame: Baseline
  description: The profile of people with psychiatric disorders who use psychedelic substances for therapeutic purposes will be assessed by interview
  arm group label: Patients using psychedelic substances
  description: Adult patients self-administering psychedelic substances in psychiatric disorders
  intervention type: Diagnostic Test
  intervention name: Interview
  description: An interview will be conducted to describe the experiences of people with psychiatric disorders who use psychedelic substances for therapeutic purposes
  arm group label: Patients using psychedelic substances
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Antoine YRONDI, PH
  role: Principal Investigator
  affiliation: University Hospital, Toulouse
  last name: Antoine YRONDI, PH
  phone: 0561778603
  email: yrondi.a@chu-toulouse.fr
  last name: Paul ROCHEFORT
  responsible party type: Sponsor
  mesh term: Mental Disorders
  mesh term: Problem Behavior