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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03753737
Other study ID # 69HCL18_0509
Secondary ID 2018-A02168-47
Status Completed
Phase
First received
Last updated
Start date November 22, 2018
Est. completion date April 29, 2019

Study information

Verified date May 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date April 29, 2019
Est. primary completion date April 29, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
France CSAPA - Service Hépato-gastroentérologie Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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