CHEMICAL SUBMISSIONGSCNCT06137599
GSC Survey: "GHB IN CHEMICAL SUBMISSION: MYTH OR REALITY?"
An observational study of CHEMICAL SUBMISSION, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
According to the media, GHB is the main substance used for chemical submission. The national survey conducted by the Addictovigilance centre of Paris on drug-facilitated assaults shows that GHB is used, but only in a very small proportion of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CHEMICAL SUBMISSION
- What is being tested?
- Capillary analysis
- How many people
- 143 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Mar 2024to 20 Mar 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any person suspecting of having been the victim of chemical submission (attack after taking a substance without the victims' knowledge or under threat
Who may be able to join
- Victims over the age of majority (≥ 18 years) on the day of the alleged events
- With a medical history leading to the suspicion of chemical submission:
- Presence of evocative clinical signs (amnesia and/or behavioural disorders and/or neurological disorders and/or other somatic disorders, etc.) AND
- In the presence of potential criminal acts (suspected or proven assault or attempted assault).
- French speaking
- Having been informed of the search
Who cannot join
- - Victims who were minors (<18 years) on the day of the alleged events.
- Victims who usually use GHB/GBL recreationally.
- Suspecting administration of a harmful substance with no crime or offence committed at the time and no attempted assault
- Victims of needle spiking
- Victims with very short hair (<3 cm), bald or shaven heads
- Victims who have exceeded the maximum time limit for taking a hair sample (6 months after the event)
Show all 9Show fewer
- Do not speak French
- Oppose to participating in the study
- Victims presenting a psychotic or cognitive syndrome likely to impair judgement Victims placed under guardianship or legal protection (article L11-22-2 CSP)
Trial locations and contacts
3 sites in 1 country.
France3 sites
Laetitia LASNE
Bondy, 93140
Elisabeth ALCARAZ
Paris, 75004
Leila CHAOUACHI
Paris, 75010
About this study
According to the media, GHB is the main substance used for chemical submission. The national survey conducted by the Addictovigilance centre of Paris on drug-facilitated assaults shows that GHB is used, but only in a very small proportion of cases. However, the short detection times for this substance point to its possible under-detection (06-09h in blood, 10-12h in urine). A pilot research protocol in Ile de France focusing on capillary analysis is therefore being proposed to volunteer victims to overcome this bias and answer this question: is the massive use of GHB in chemical submission a myth or a reality?
Read the detailed description
The Addictovigilance center of Paris (CEIP-A) has been responsible for the national chemical submission survey under the supervision of the French National Agency for the Safety of Medicines and Health Products (ANSM) since 2003, using data from expert toxicology laboratories, forensic police and forensic medicine departments. With 20 years' experience in the criminal use of substances, the center draws up an annual report on substance-facilitated assaults in order to put in place appropriate, up-to-date prevention measures.
In 2021, the #balancetonbar movement emerged in Brussels and spread like a shockwave across Belgian cities and Europe. On Instagram, women spoke out about the extent of drug-facilitated sexual assault (DFSA) in nightclubs and denounced the " laissez faire " attitude of the political authorities. The movement is resonating in France and getting louder : #balancetonbar has now been joined by #MetooGHB, which puts the so-called "rape drug" in the spotlight. But what's really going on?
A retrospective study of the national survey data from 2010 to 2019 reports only 26 chemical submissions (CS) attributable to GHB/GBL out of 617 CS identified (4.2%) among 4349 suspected cases. However, this study highlights all the limits to the disclosure of GHB (low proportion of complaints filed, speed of elimination of this substance from the usual matrices, insufficient number of court orders for hair analysis).
With the aim to eliminate the limitations identified as far as possible and answer the question "Is the massive use of GHB in chemical submission a myth or a reality?", a pilot research protocol, centred on capillary analysis, is being proposed to 200 victims in the Ile de France region.
This is a non-interventional, multi-centre, category 3 study, the only acts (hair sampling) or procedures (chemical submission declaration form) are risk-free and do not affect the management of participants.
Victims are included whether or not they have lodged a complaint, in collaboration with forensic medicine departments, HIV and STI screening Center and Victim Support Associations. Referred to the parisien CEIP-A, 3 strands of hair are sampled after an interview in which the victim's history and voluntary drug use data were taken. A pre-analytical treatment of the hair (washing, fragmentation), followed by detection by high-resolution mass spectrometry is carried out by an expert laboratory in search of GHB and other known chemical submission agents (illicit drugs and psychoactive medicines).
To meet our objective, a comparative study of the results of the GCS protocol and the survey history was carried out using an exact binomial test. This study will also provide an opportunity for a more general discussion of the value of hair analysis in the detection of chemical submission agents.
- Conditions
- CHEMICAL SUBMISSION
- Being tested
- Capillary analysis
- Keywords
- CHEMICAL SUBMISSION, Chemical vulnerability, Drug facilitated Crime, Gamma hydroxybutyrate, Capillary analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary analysisOther
Samples taken between 2 and 6 months after the presumed events. A pre-analytical treatment of the hair (washing, fragmentation), followed by detection by high-resolution mass spectrometry is carried out by an expert laboratory to search for both GHB and psychoactive drugs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of exogenous GHB intake without the knowledge of the victims through hair analysis.
A double CEIP-A/Expert Laboratory interpretation is carried out according to the evaluation criteria defined by the national chemical submission survey Steering Committee.
Measured: Samples taken between 2 and 6 months after the presumed events: GHB analysis in the hair can no longer be interpreted after 6 months due to the hydrosoluble nature of GHB and repetitive hair washing.
Secondary outcomes (1)
Evidence of the use of a psychoactive substance (other than GHB) without the knowledge of the victims via capillary analysis.
A double CEIP-A/Expert Laboratory interpretation is carried out according to the evaluation criteria defined by the national chemical submission survey Steering Committee.
Measured: Samples taken between 2 and 6 months after the presumed events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Mar 2024
- Primary completion20 Nov 2025
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHEMICAL SUBMISSIONStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Mission Interministérielle de Lutte contre les Drogues et les Conduites Addictives - MILDECA
- Responsible party
- Sponsor
- Investigators
- Leïla CHAOUACHI, PharmD, Study chair, APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARISAnne Batisse, PharmD, Study director, APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137599
- Sponsor's protocol ID
- APHP230579
- Acronym
- GSC
- Status last verified
- Jul 2025
- First submitted
- 13 Nov 2023
- Last updated
- 6 Jul 2026
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GSC Survey: "GHB IN CHEMICAL SUBMISSION: MYTH OR REALITY?"
- ClinicalTrials.gov ID
- NCT06137599
- Acronym / sponsor ID
- GSC / APHP230579
- Conditions
- CHEMICAL SUBMISSION
- Keywords
- CHEMICAL SUBMISSION, Chemical vulnerability, Drug facilitated Crime, Gamma hydroxybutyrate, Capillary analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Mission Interministérielle de Lutte contre les Drogues et les Conduites Addictives - MILDECA
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 18 Nov 2023 (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.
According to the media, GHB is the main substance used for chemical submission. The national survey conducted by the Addictovigilance centre of Paris on drug-facilitated assaults shows that GHB is used, but only in a very small proportion of cases. However, the short detection times for this substance point to its possible under-detection (06-09h in blood, 10-12h in urine). A pilot research protocol in Ile de France focusing on capillary analysis is therefore being proposed to volunteer victims to overcome this bias and answer this question: is the massive use of GHB in chemical submission a myth or a reality?
Detailed description
The Addictovigilance center of Paris (CEIP-A) has been responsible for the national chemical submission survey under the supervision of the French National Agency for the Safety of Medicines and Health Products (ANSM) since 2003, using data from expert toxicology laboratories, forensic police and forensic medicine departments. With 20 years' experience in the criminal use of substances, the center draws up an annual report on substance-facilitated assaults in order to put in place appropriate, up-to-date prevention measures.
In 2021, the #balancetonbar movement emerged in Brussels and spread like a shockwave across Belgian cities and Europe. On Instagram, women spoke out about the extent of drug-facilitated sexual assault (DFSA) in nightclubs and denounced the " laissez faire " attitude of the political authorities. The movement is resonating in France and getting louder : #balancetonbar has now been joined by #MetooGHB, which puts the so-called "rape drug" in the spotlight. But what's really going on?
A retrospective study of the national survey data from 2010 to 2019 reports only 26 chemical submissions (CS) attributable to GHB/GBL out of 617 CS identified (4.2%) among 4349 suspected cases. However, this study highlights all the limits to the disclosure of GHB (low proportion of complaints filed, speed of elimination of this substance from the usual matrices, insufficient number of court orders for hair analysis).
With the aim to eliminate the limitations identified as far as possible and answer the question "Is the massive use of GHB in chemical submission a myth or a reality?", a pilot research protocol, centred on capillary analysis, is being proposed to 200 victims in the Ile de France region.
This is a non-interventional, multi-centre, category 3 study, the only acts (hair sampling) or procedures (chemical submission declaration form) are risk-free and do not affect the management of participants.
Victims are included whether or not they have lodged a complaint, in collaboration with forensic medicine departments, HIV and STI screening Center and Victim Support Associations. Referred to the parisien CEIP-A, 3 strands of hair are sampled after an interview in which the victim's history and voluntary drug use data were taken. A pre-analytical treatment of the hair (washing, fragmentation), followed by detection by high-resolution mass spectrometry is carried out by an expert laboratory in search of GHB and other known chemical submission agents (illicit drugs and psychoactive medicines).
To meet our objective, a comparative study of the results of the GCS protocol and the survey history was carried out using an exact binomial test. This study will also provide an opportunity for a more general discussion of the value of hair analysis in the detection of chemical submission agents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any person suspecting of having been the victim of chemical submission (attack after taking a substance without the victims' knowledge or under threat
Key inclusion criteria (6 listed)
- Victims over the age of majority (≥ 18 years) on the day of the alleged events
- With a medical history leading to the suspicion of chemical submission:
- Presence of evocative clinical signs (amnesia and/or behavioural disorders and/or neurological disorders and/or other somatic disorders, etc.) AND
- In the presence of potential criminal acts (suspected or proven assault or attempted assault).
- French speaking
Key exclusion criteria (9 listed)
- - Victims who were minors (<18 years) on the day of the alleged events.
- Victims who usually use GHB/GBL recreationally.
- Suspecting administration of a harmful substance with no crime or offence committed at the time and no attempted assault
- Victims of needle spiking
- Victims with very short hair (<3 cm), bald or shaven heads
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 |
|---|---|---|
| Capillary analysisSamples taken between 2 and 6 months after the presumed events. A pre-analytical treatment of the hair (washing, fragmentation), followed by detection by high-resolution mass spectrometry is carried out by an expert laboratory to search for both GHB and psychoactive drugs. | Other | – |
Primary outcome
Evidence of exogenous GHB intake without the knowledge of the victims through hair analysis.
Time frame: Samples taken between 2 and 6 months after the presumed events: GHB analysis in the hair can no longer be interpreted after 6 months due to the hydrosoluble nature of GHB and repetitive hair washing.
A double CEIP-A/Expert Laboratory interpretation is carried out according to the evaluation criteria defined by the national chemical submission survey Steering Committee.
1 secondary outcome
Evidence of the use of a psychoactive substance (other than GHB) without the knowledge of the victims via capillary analysis.
Time frame: Samples taken between 2 and 6 months after the presumed events.
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 6 Jul 2026.
- 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.
Leïla CHAOUACHI, PharmD study chair
APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
Anne Batisse, PharmD study director
APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CHEMICAL SUBMISSION, run by Assistance Publique - Hôpitaux de Paris at 3 sites 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 6 inclusion and 9 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Evidence of exogenous GHB intake without the knowledge of the victims through hair analysis. (time frame: Samples taken between 2 and 6 months after the presumed events: GHB analysis in the hair can no longer be interpreted after 6 months due to the hydrosoluble nature of GHB and repetitive hair washing.). 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 6 Jul 2026.