NCT03753737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 22, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2019

Completed
Last Updated

May 22, 2019

Status Verified

May 1, 2019

Enrollment Period

5 months

First QC Date

November 22, 2018

Last Update Submit

May 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Personality disorders

    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

Study Arms (2)

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

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

Interventions

* 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.

ChemsexControl

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSAPA - Service Hépato-gastroentérologie

Lyon, 69004, France

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2018

First Posted

November 27, 2018

Study Start

November 22, 2018

Primary Completion

April 29, 2019

Study Completion

April 29, 2019

Last Updated

May 22, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations