Substance Use DisordersPSYCHEMSNCT03753737
Personality Disorders and Substance Use Disorders in a Sexual Context in the Man Having Sex With Other Men Population
An observational study of Substance Use Disorders, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Questionnaires and semi-structured interview
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2018to 29 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Deprivation of liberty
- Guardianship
- Chemsex group: simple experience of chemsex without substance use disorder
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Substance Use Disorders
- Being tested
- Questionnaires and semi-structured interview
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and semi-structured interviewOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Questionnaires and semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start22 Nov 2018
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753737
- Sponsor's protocol ID
- 69HCL18_0509
- Other IDs
- 2018-A02168-47
- Acronym
- PSYCHEMS
- Status last verified
- May 2019
- First submitted
- 22 Nov 2018
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03753737
- Acronym / sponsor ID
- PSYCHEMS / 69HCL18_0509
- Conditions
- Substance Use Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemsex | – | Other: Questionnaires and semi-structured interviewMen 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. |
| Control | – | Other: Questionnaires and semi-structured interviewMen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Deprivation of liberty
- Guardianship
- Chemsex group: simple experience of chemsex without substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Chemsex, Control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personality disorders (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.