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Personality Disorders and Substance Use Disorders in a Sexual Context in the Man Having Sex With Other Men Population (PSYCHEMS)

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ClinicalTrials.gov Identifier: NCT03753737
Recruitment Status : Not yet recruiting
First Posted : November 27, 2018
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.


Condition or disease Intervention/treatment
Substance Use Disorders Other: Questionnaires and semi-structured interview

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Study Type : Observational
Estimated Enrollment : 74 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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.
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Chemsex
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.
Other: Questionnaires and semi-structured interview
  • 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.

Control
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.
Other: Questionnaires and semi-structured interview
  • 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.




Primary Outcome Measures :
  1. Personality disorders [ Time Frame: 1 day ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men who have Sex with Men (MSM) with past or present substance-related disorder related to chemsex, and sexually active MSM who have never experienced chemsex.
Criteria

Inclusion Criteria:

  • Age over 18
  • Men who have Sex with Men
  • No opposition to participate to the study
  • Chemsex group: to attend 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.
  • Control group: to consult for a PrEP prescription and never have used cathinones, GHB/GBL, methamphetamine, cocaine or ketamine before or during sex.

Exclusion Criteria:

  • Deprivation of liberty
  • Guardianship
  • Chemsex group: simple experience of chemsex without substance use disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753737


Contacts
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Contact: Philippe LACK, MD 04 26 73 25 90 ext +33 philippe.lack@chu-lyon.fr

Locations
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France
CSAPA - Service Hépato-gastroentérologie Not yet recruiting
Lyon, France, 69004
Contact: Philippe LACK, MD    04 26 73 25 90 ext +33    philippe.lack@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03753737     History of Changes
Other Study ID Numbers: 69HCL18_0509
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Personality Disorders
Substance-Related Disorders
Pathologic Processes
Mental Disorders
Chemically-Induced Disorders