Addiction ChemicalTU CHEMSEXNCT06476873
Substance Use Disorder in Chemsex Practice
A study testing Online self-questionnaire. in people with Addiction Chemical and Use, Substance, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
Trial summary
The main aim of this descriptive cross-sectional study is to assess the prevalence of chemsex substance use disorder among chemsexers via an online self-questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Addiction Chemical, Use, Substance
- What is being tested?
- Online self-questionnaire.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2024to 30 Aug 2025
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older.
- Proficiency in written French
- Have practised chemsex at least once in the last 12 months.
- Agree to participate in the study.
Who cannot join
- Have not experimented with chemsex in the last 12 months
- Participation in other ongoing research
- Insufficient written comprehension of French
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Charles PERRENS
Bordeaux, 33076
Melina FATSEAS, MD, Prof, 0524549000, melina.fatseas@chu-bordeaux.fr
Helen SAVARIEAU, 0556563556, hsavarieau@ch-perrens.fr
About this study
Official title: Substance Use Disorder in Chemsex Practice: Evaluation of the Prevalence of the Disorder Among Users Via an Online Self-questionnaire
The main aim of this descriptive cross-sectional study is to assess the prevalence of chemsex substance use disorder among chemsexers via an online self-questionnaire.
Read the detailed description
Chemsex appeared in Europe around 2006 and in France in 2010. It involves the use of psychoactive substances in a sexual context to enhance, initiate, facilitate or prolong sexual intercourse through the psychoactive effects of the molecules consumed. These molecules are essentially synthetic cathinones, GHB/GBL, MDMA, methamphetamines, cocaine and ketamine. These products are often used in combination with erectile dysfunction treatments (side effects of the molecules). This practice is thought to affect almost 20% of MSM.
This use has numerous social, somatic, psychiatric and addictive consequences. Studies have mainly focused on infectious risks, psychiatric complications (e.g. anxiety and depression) or the prevalence of this phenomenon. However, no study has assessed the prevalence of chemsex-related substance use disorders among these users.
- Conditions
- Addiction Chemical, Use, Substance
- Being tested
- Online self-questionnaire.
- 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.
Online self-questionnaire.Behavioural
Descriptive, cross-sectional study This study is aimed at adult chemsex users over the last 12 months (having experimented with chemsex at least once over the last 12 months) and with a good understanding of French.
An online LimeSurvey-type self-questionnaire will be accessible via a URL link to collect and secure the data. A presentation of the study, information on chemsex and help and care services, as well as the information note will be available.
The questionnaire will be distributed via a QR code, giving direct access to the study's web page, or directly via the web link. Posters and flyers will be used in hospitals and/or private clinics, addictology centers, STI prevention and screening centers and associations, as well as via social networks, dating apps and sites, and the online and print press.
What is being measured
The primary outcome is the main question the study is designed to answer.
DSM-5 diagnosis of substance use disorder for chemsex.
Assessment of the prevalence of chemsex substance use disorder among chemsexers via an online self-questionnaire.
Measured: 1 day
Secondary outcomes (4)
Describing the sociodemographic characteristics of this population
Socio-demographic characteristics
Measured: 1 day
Describing the consumption practices of this population
Consumption practices
Measured: 1 day
Describing the sexual practices of this population
Sexual practices
Measured: 1 day
Explore the existence of chemsex use disorder as a clinical entity in its own right
DSM-5 diagnostic criteria for substance use disorder, adapted to assess chemsex addiction as a single clinical entity
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 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Addiction ChemicalStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cohort
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476873
- Sponsor's protocol ID
- 2024-A00737-40
- Acronym
- TU CHEMSEX
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diestelmann M, Zangl A, Herrle I, Koch E, Graw M, Paul LD. MDPV in forensic routine cases: Psychotic and aggressive behavior in relation to plasma concentrations. Forensic Sci Int. 2018 Feb;283:72-84. doi: 10.1016/j.forsciint.2017.12.003. Epub 2017 Dec 8.
PubMed 29275216Blanc JV, Burdairon JD, Malandain L, Ferreri F, Mouchabac S, Adrien V. Attachment and Mental Health of Men Having Sex with Men Engaging in Chemsex: Is Substance Abuse Only the Tip of the Iceberg? J Homosex. 2024 Oct 14;71(12):2875-2894. doi: 10.1080/00918369.2023.2266086. Epub 2023 Oct 10.
PubMed 37815854Serre A, Vuillot O, Eiden C, Gambier J, Berger A, Mathieu O, Nefau T, Sebbane M, Donnadieu-Rigole H, Peyriere H. Acute Psychiatric Disorders Related to Fake Cathinone: Ephylone. J Anal Toxicol. 2019 Aug 23;43(7):e1-e2. doi: 10.1093/jat/bkz020. No abstract available.
PubMed 31095710Evers YJ, Van Liere GAFS, Hoebe CJPA, Dukers-Muijrers NHTM. Chemsex among men who have sex with men living outside major cities and associations with sexually transmitted infections: A cross-sectional study in the Netherlands. PLoS One. 2019 May 14;14(5):e0216732. doi: 10.1371/journal.pone.0216732. eCollection 2019.
PubMed 31086390Gilbart VL, Simms I, Gobin M, Oliver I, Hughes G. High-risk drug practices in men who have sex with men. Lancet. 2013 Apr 20;381(9875):1358-1359. doi: 10.1016/S0140-6736(13)60882-X. No abstract available.
PubMed 23601946
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use Disorder in Chemsex Practice: Evaluation of the Prevalence of the Disorder Among Users Via an Online Self-questionnaire
- ClinicalTrials.gov ID
- NCT06476873
- Acronym / sponsor ID
- TU CHEMSEX / 2024-A00737-40
- Conditions
- Addiction Chemical, Use, Substance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Charles Perrens, BordeauxOther government
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 27 Jun 2024 (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.
The main aim of this descriptive cross-sectional study is to assess the prevalence of chemsex substance use disorder among chemsexers via an online self-questionnaire.
Detailed description
Chemsex appeared in Europe around 2006 and in France in 2010. It involves the use of psychoactive substances in a sexual context to enhance, initiate, facilitate or prolong sexual intercourse through the psychoactive effects of the molecules consumed. These molecules are essentially synthetic cathinones, GHB/GBL, MDMA, methamphetamines, cocaine and ketamine. These products are often used in combination with erectile dysfunction treatments (side effects of the molecules). This practice is thought to affect almost 20% of MSM.
This use has numerous social, somatic, psychiatric and addictive consequences. Studies have mainly focused on infectious risks, psychiatric complications (e.g. anxiety and depression) or the prevalence of this phenomenon. However, no study has assessed the prevalence of chemsex-related substance use disorders among these users.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be 18 years of age or older.
- Proficiency in written French
- Have practised chemsex at least once in the last 12 months.
- Agree to participate in the study.
Key exclusion criteria (3 listed)
- Have not experimented with chemsex in the last 12 months
- Participation in other ongoing research
- Insufficient written comprehension of French
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 |
|---|---|---|
| Online self-questionnaire.Descriptive, cross-sectional study This study is aimed at adult chemsex users over the last 12 months (having experimented with chemsex at least once over the last 12 months) and with a good understanding of French. An online LimeSurvey-type self-questionnaire will be accessible via a URL link to collect and secure the data. A presentation of the study, information on chemsex and help and care services, as well as the information note will be available. The questionnaire will be distributed via a QR code, giving direct access to the study's web page, or directly via the web link. Posters and flyers will be used in hospitals and/or private clinics, addictology centers, STI prevention and screening centers and associations, as well as via social networks, dating apps and sites, and the online and print press. | Behavioural | – |
Primary outcome
DSM-5 diagnosis of substance use disorder for chemsex.
Time frame: 1 day
Assessment of the prevalence of chemsex substance use disorder among chemsexers via an online self-questionnaire.
4 secondary outcomes
Describing the sociodemographic characteristics of this population
Time frame: 1 day
Describing the consumption practices of this population
Time frame: 1 day
Describing the sexual practices of this population
Time frame: 1 day
Explore the existence of chemsex use disorder as a clinical entity in its own right
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Background: PubMed 29275216Diestelmann M, Zangl A, Herrle I, Koch E, Graw M, Paul LD. MDPV in forensic routine cases: Psychotic and aggressive behavior in relation to plasma concentrations. Forensic Sci Int. 2018 Feb;283:72-84. doi: 10.1016/j.forsciint.2017.12.003. Epub 2017 Dec 8.
- Background: PubMed 37815854Blanc JV, Burdairon JD, Malandain L, Ferreri F, Mouchabac S, Adrien V. Attachment and Mental Health of Men Having Sex with Men Engaging in Chemsex: Is Substance Abuse Only the Tip of the Iceberg? J Homosex. 2024 Oct 14;71(12):2875-2894. doi: 10.1080/00918369.2023.2266086. Epub 2023 Oct 10.
- Background: PubMed 31095710Serre A, Vuillot O, Eiden C, Gambier J, Berger A, Mathieu O, Nefau T, Sebbane M, Donnadieu-Rigole H, Peyriere H. Acute Psychiatric Disorders Related to Fake Cathinone: Ephylone. J Anal Toxicol. 2019 Aug 23;43(7):e1-e2. doi: 10.1093/jat/bkz020. No abstract available.
- Background: PubMed 31086390Evers YJ, Van Liere GAFS, Hoebe CJPA, Dukers-Muijrers NHTM. Chemsex among men who have sex with men living outside major cities and associations with sexually transmitted infections: A cross-sectional study in the Netherlands. PLoS One. 2019 May 14;14(5):e0216732. doi: 10.1371/journal.pone.0216732. eCollection 2019.
- Background: PubMed 23601946Gilbart VL, Simms I, Gobin M, Oliver I, Hughes G. High-risk drug practices in men who have sex with men. Lancet. 2013 Apr 20;381(9875):1358-1359. doi: 10.1016/S0140-6736(13)60882-X. No abstract available.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online self-questionnaire. in people with Addiction Chemical and Use, Substance, run by Centre Hospitalier Charles Perrens, Bordeaux 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 4 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: status not confirmed, as of the sponsor's last update on 27 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melina FATSEAS (05 24 54 90 00, melina.fatseas@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DSM-5 diagnosis of substance use disorder for chemsex. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06476873, which also lists 5 linked publications.
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 27 Jun 2024.