<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/NCT02969694</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0746</org_study_id>
    <nct_id>NCT02969694</nct_id>
  </id_info>
  <brief_title>Evaluation of Relationship Between Hypersexuality and Psychostimulant Among Men Who Have Sex With Men</brief_title>
  <acronym>HYPERCHEM</acronym>
  <official_title>Evaluation of Relationship Between Hypersexuality and Psychostimulant Among Men Who Have Sex With Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Survey of fifty new psychoactive substances consumers in a context of MTM sexual intercourse.&#xD;
&#xD;
      Evaluation using an hetero-assessment questionnaire about the link between hypersexual&#xD;
      disorder and the use of synthetic cathinone.&#xD;
&#xD;
      Evaluation on psychoactive drug addiction, the induced or pre-existing sexual practices and&#xD;
      the medico-psycho-social consequences of those practices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>G-STAT questionnaire</measure>
    <time_frame>Day 0</time_frame>
    <description>Determine whether there are elements sexual addiction or if its elements are induced by the specific use of psychostimulants. The determination will be made using the interrogation conducted during the CSAPA consultation and G-STAT questionnaire.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Psychoactive Substances Consumers</condition>
  <arm_group>
    <arm_group_label>Patients who use psychostimulants products in sexual contexts</arm_group_label>
    <description>Patients who come to the CSAPA at the Croix-Rousse Hospital, Lyon France following the use of psychostimulants products in sexual contexts.These patients come for an addictologique support.&#xD;
The patients will answer to the G-STAT questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>G-STAT questionnaire</intervention_name>
    <description>Patients will have a consultation with an addiction specialist physician. During the consultation, the physician ask the patient about these sexual practice and the use of psychostimulants. The patient will answer to the G-STAT questionnaire. This questionnaire allows the physician to perform an initial assessment of the patient's sexual addiction.&#xD;
The entire consultation takes place in the usual practice of consultations for this addiction.</description>
    <arm_group_label>Patients who use psychostimulants products in sexual contexts</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        men who have sex with men and who take psychostimulants products in sexual contexts&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  Inclusion Criteria:&#xD;
&#xD;
               -  Patients ≥ 18 years&#xD;
&#xD;
               -  Male homosexual and / or bisexual who come to the CSAPA at the Croix-Rousse&#xD;
                  Hospital, Lyon France following the use of psychostimulants products in sexual&#xD;
                  contexts&#xD;
&#xD;
               -  Patients who have received clear information and not opposed to participate in&#xD;
                  the study&#xD;
&#xD;
               -  Patients affiliated to a social security scheme or similar&#xD;
&#xD;
               -  Patients not undergoing a measure of legal protection&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
               -  Opposition to participation in the study&#xD;
&#xD;
               -  Patients &lt; 18 years&#xD;
&#xD;
               -  Pregnant women or breastfeeding&#xD;
&#xD;
               -  Deprived of individual liberty&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Philippe Lack</last_name>
    <phone>+33 4 26 73 25 87</phone>
    <email>philippe.lack@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Frédéric Buathier, nurse</last_name>
    <phone>+33 4 26 73 25 90</phone>
    <email>frederic.buathier@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe Lack</last_name>
      <phone>+ 33 4 26 73 25 87</phone>
      <email>philippe.lack@chu-lyon.fr</email>
    </contact>
    <contact_backup>
      <last_name>Frédéric Buathier</last_name>
      <email>Frederic.Buathier@chu-lyon.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Philippe Lack</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>addiction</keyword>
  <keyword>hypersexuality</keyword>
  <keyword>psychostimulants</keyword>
  <!-- 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/NCT02969694
org study id: 69HCL16_0746
nct id: NCT02969694
lead sponsor: 
has dmc: No
Survey of fifty new psychoactive substances consumers in a context of MTM sexual intercourse.

      Evaluation using an hetero-assessment questionnaire about the link between hypersexual
      disorder and the use of synthetic cathinone.

      Evaluation on psychoactive drug addiction, the induced or pre-existing sexual practices and
      the medico-psycho-social consequences of those practices.
time perspective: Prospective
measure: G-STAT questionnaire
time frame: Day 0
description: Determine whether there are elements sexual addiction or if its elements are induced by the specific use of psychostimulants. The determination will be made using the interrogation conducted during the CSAPA consultation and G-STAT questionnaire.
arm group label: Patients who use psychostimulants products in sexual contexts
description: Patients who come to the CSAPA at the Croix-Rousse Hospital, Lyon France following the use of psychostimulants products in sexual contexts.These patients come for an addictologique support.
The patients will answer to the G-STAT questionnaire.
intervention type: Other
intervention name: G-STAT questionnaire
description: Patients will have a consultation with an addiction specialist physician. During the consultation, the physician ask the patient about these sexual practice and the use of psychostimulants. The patient will answer to the G-STAT questionnaire. This questionnaire allows the physician to perform an initial assessment of the patient's sexual addiction.
The entire consultation takes place in the usual practice of consultations for this addiction.
arm group label: Patients who use psychostimulants products in sexual contexts
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe Lack
phone: +33 4 26 73 25 87
email: philippe.lack@chu-lyon.fr
last name: Frédéric Buathier, nurse
phone: +33 4 26 73 25 90
email: frederic.buathier@chu-lyon.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor