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

May 21, 2019 updated by: Hospices Civils de Lyon

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.

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lyon, France, 69004
        • CSAPA - Service Hépato-gastroentérologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.
  • 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.
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 22, 2018

Primary Completion (ACTUAL)

April 29, 2019

Study Completion (ACTUAL)

April 29, 2019

Study Registration Dates

First Submitted

November 22, 2018

First Submitted That Met QC Criteria

November 22, 2018

First Posted (ACTUAL)

November 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 69HCL18_0509
  • 2018-A02168-47 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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