<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/NCT03753737</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL18_0509</org_study_id>
    <secondary_id>2018-A02168-47</secondary_id>
    <nct_id>NCT03753737</nct_id>
  </id_info>
  <brief_title>Personality Disorders and Substance Use Disorders in a Sexual Context in the Man Having Sex With Other Men Population</brief_title>
  <acronym>PSYCHEMS</acronym>
  <official_title>A Study of the Relationship Between Personality Disorders and Substance Use Disorders in a Sexual Context in the Man Having Sex With Other Men Population - An Observational Study Based on a Cross-sectional Survey.</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chemsex refers to the use of psychoactive drugs in a sexual context, mainly cathinones,&#xD;
      GHB/GBL, methamphetamine, cocaine and ketamine. This can cause infectious or psychiatric&#xD;
      complications, addictions, and often goes with high risk sexual behaviours. Recent studies&#xD;
      have highlighted the relationship between personality disorders, substance use disorders and&#xD;
      risky sexual behaviours. It is important to understand the factors associated with chemsex in&#xD;
      order to offer adapted prevention and care plans.&#xD;
&#xD;
      The study hypothesis is that personality disorders, evaluated with the PDQ-4+ questionnaire,&#xD;
      are more frequent among man having sex with other men with a substance use disorder linked to&#xD;
      chemsex than among man having sex with other men who have never practised chemsex.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2018</start_date>
  <completion_date type="Actual">April 29, 2019</completion_date>
  <primary_completion_date type="Actual">April 29, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Personality disorders</measure>
    <time_frame>1 day</time_frame>
    <description>Positive score for 1 or more DSM-V personality disorders(PD) using French version of the PDQ4+,Personality Diagnostic Questionnaire-Version4,comprising:&#xD;
Combined score of overall personality disturbance (ranges0 to 93);higher values reflect a more important personality disturbance&#xD;
Borderline PD:Score Ranges(SR) 0 to 9,positive(+) if ≥ 5&#xD;
Narcissistic PD:SR 0 to 9,+ if ≥5&#xD;
Histrionic PD:SR 0 to 8,+ if ≥5&#xD;
Antisocial PD:SR 0 to 8,+ if ≥4 and criteria 99 positive&#xD;
Avoidant PD:SR 0 to 7,+ if ≥4&#xD;
Dependent PD:SR 0 to 8,+ if ≥5&#xD;
Obsessive-Compulsive PD:SR 0 to 8,+ if ≥4&#xD;
Paranoid PD:SR 0 to 7,+ if ≥4&#xD;
Schizoid PD:SR 0 to 7,+ if ≥4&#xD;
Schizotypal PD:SR 0 to 9,+ if ≥5&#xD;
Questionnaire must be interpreted with caution if 1 of the 2 &quot;Suspect Questionnaire&quot; items is +, or if at least 2 of the 4 &quot;Too Good&quot; items are +&#xD;
Negativistic and depressive PD are evaluated with the PDQ4+ but are not part of the outcome measures in the study</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">94</enrollment>
  <condition>Substance Use Disorders</condition>
  <arm_group>
    <arm_group_label>Chemsex</arm_group_label>
    <description>Men who have Sex with Men (MSM) attending an addiction care center for past or present mild, moderate or severe substance-related disorder(s) according to DSM-V criteria, occurring in a sexual context and concerning cathinones, GHB/GBL, methamphetamine, cocaine and/or ketamine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Men who have Sex with Men (MSM) consulting for a PrEP (HIV Pre-Exposure Prophylaxis) prescription who have never used cathinones, GHB/GBL, methamphetamine, cocaine or ketamine before or during sex.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires and semi-structured interview</intervention_name>
    <description>Questionnaires : PDQ-4+ (personality disorders), HAD (Anxiety and Depression), AUDIT-c (Alcohol consumption), CTQ-SF (Childhood Trauma Questionnaire).&#xD;
Semi-structured interview : Evaluation of socio-demographic characteristics, psychiatric and addiction comorbidities, sexually transmitted infections, sexual practices, sexual dysfunction, hypersexual disorder.</description>
    <arm_group_label>Chemsex</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men who have Sex with Men (MSM) with past or present substance-related disorder related to&#xD;
        chemsex, and sexually active MSM who have never experienced chemsex.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18&#xD;
&#xD;
          -  Men who have Sex with Men&#xD;
&#xD;
          -  No opposition to participate to the study&#xD;
&#xD;
          -  Chemsex group: to attend an addiction care center for past or present mild, moderate&#xD;
             or severe substance-related disorder(s) according to DSM-V criteria, occurring in a&#xD;
             sexual context and concerning cathinones, GHB/GBL, methamphetamine, cocaine and/or&#xD;
             ketamine.&#xD;
&#xD;
          -  Control group: to consult for a PrEP prescription and never have used cathinones,&#xD;
             GHB/GBL, methamphetamine, cocaine or ketamine before or during sex.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Deprivation of liberty&#xD;
&#xD;
          -  Guardianship&#xD;
&#xD;
          -  Chemsex group: simple experience of chemsex without substance use disorder&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CSAPA - Service Hépato-gastroentérologie</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 21, 2019</last_update_submitted>
  <last_update_submitted_qc>May 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Personality Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03753737
org study id: 69HCL18_0509
secondary id: 2018-A02168-47
nct id: NCT03753737
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chemsex refers to the use of psychoactive drugs in a sexual context, mainly cathinones,
      GHB/GBL, methamphetamine, cocaine and ketamine. This can cause infectious or psychiatric
      complications, addictions, and often goes with high risk sexual behaviours. Recent studies
      have highlighted the relationship between personality disorders, substance use disorders and
      risky sexual behaviours. It is important to understand the factors associated with chemsex in
      order to offer adapted prevention and care plans.

      The study hypothesis is that personality disorders, evaluated with the PDQ-4+ questionnaire,
      are more frequent among man having sex with other men with a substance use disorder linked to
      chemsex than among man having sex with other men who have never practised chemsex.
observational model: Other
time perspective: Cross-Sectional
measure: Personality disorders
time frame: 1 day
description: Positive score for 1 or more DSM-V personality disorders(PD) using French version of the PDQ4+,Personality Diagnostic Questionnaire-Version4,comprising:
Combined score of overall personality disturbance (ranges0 to 93);higher values reflect a more important personality disturbance
Borderline PD:Score Ranges(SR) 0 to 9,positive(+) if ≥ 5
Narcissistic PD:SR 0 to 9,+ if ≥5
Histrionic PD:SR 0 to 8,+ if ≥5
Antisocial PD:SR 0 to 8,+ if ≥4 and criteria 99 positive
Avoidant PD:SR 0 to 7,+ if ≥4
Dependent PD:SR 0 to 8,+ if ≥5
Obsessive-Compulsive PD:SR 0 to 8,+ if ≥4
Paranoid PD:SR 0 to 7,+ if ≥4
Schizoid PD:SR 0 to 7,+ if ≥4
Schizotypal PD:SR 0 to 9,+ if ≥5
Questionnaire must be interpreted with caution if 1 of the 2 "Suspect Questionnaire" items is +, or if at least 2 of the 4 "Too Good" items are +
Negativistic and depressive PD are evaluated with the PDQ4+ but are not part of the outcome measures in the study
arm group label: Chemsex
description: Men who have Sex with Men (MSM) attending an addiction care center for past or present mild, moderate or severe substance-related disorder(s) according to DSM-V criteria, occurring in a sexual context and concerning cathinones, GHB/GBL, methamphetamine, cocaine and/or ketamine.
arm group label: Control
description: Men who have Sex with Men (MSM) consulting for a PrEP (HIV Pre-Exposure Prophylaxis) prescription who have never used cathinones, GHB/GBL, methamphetamine, cocaine or ketamine before or during sex.
intervention type: Other
intervention name: Questionnaires and semi-structured interview
description: Questionnaires : PDQ-4+ (personality disorders), HAD (Anxiety and Depression), AUDIT-c (Alcohol consumption), CTQ-SF (Childhood Trauma Questionnaire).
Semi-structured interview : Evaluation of socio-demographic characteristics, psychiatric and addiction comorbidities, sexually transmitted infections, sexual practices, sexual dysfunction, hypersexual disorder.
arm group label: Chemsex
arm group label: Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Personality Disorders
sharing ipd: No