IntoxicationNCT06207396
Characteristics of Spiking in Ghent: a Multicentric Prospective Observational Study..
An observational study of Intoxication and Unintended Ingestion of Product, run by University Hospital, Ghent at 4 sites in Belgium.
Trial summary
This study aims to document the incidence and characteristics of spiking in the Ghent region, both anamnestically and by toxicological analysis. Spiking will be analyzed by immunoassay testing and high-resolution screening according to the protocol in the laboratory of UZ Gent; Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intoxication, Unintended Ingestion of Product
- What is being tested?
- serum and urine analysis
- How many people
- 107 participants
- Where
- 4 sitesBelgium
- Study dates
- 1 Jun 2023to 31 May 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult population (18+, all genders) presenting with alleged spiking to the emergency department
Who may be able to join
- >18 years
- Patient self-reports suspicion of spiking OR there is a suspicion of spiking by physician, police, paramedics or patient's companions
- willingness to provide urine and/or blood samples (depending on timing after event)
Who cannot join
- Reporting more than 5 days after spiking
- Unable to reliably complete the questionnaire (can be after clinical observation/recovery).
- Not declaring proficiency in the language in which informed consent is offered (Dutch/English).
- Not agreeing to the informed consent.
- Do not consent to blood and urine collection and/or analysis.
- There is a suspicion of Drug Facilitated Sexual Assault (to be referred to Care Center Sexual Violence, ZSG, where parallel study is ongoing).
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
AZ Maria Middelares
Ghent, 9000
Spoedgevallendienst AZ Jan Palfijn
Ghent, 9000
Spoedgevallendienst AZ St. Lucas
Ghent, 9000
Spoedgevallendienst
Ghent, 9000
About this study
Official title: Characteristics of Spiking in Ghent: A Multicentric Prospective Observational Study
This study aims to document the incidence and characteristics of spiking in the Ghent region, both anamnestically and by toxicological analysis.
Spiking will be analyzed by immunoassay testing and high-resolution screening according to the protocol in the laboratory of UZ Gent;
Read the detailed description
This study aims at objectivating and characterizing the patients with alleged spiking in the city of Ghent.
Every patient who presents at one of the four (out of four) emergency departments of Ghent, with a suspicion of spiking (drink/food/needle-spiking included), will be offered to take part of this study.
The study entails a list of questions for the patient regarding demographics, recent own medication/drug/alcohol use and experienced symptoms; whilst the caregiver (doctor/nurse) completes a questionnaire regarding symptoms at time of presentation.
For a presentation within 48h after event, both blood and urine samples are requested from the patient. When presenting between 48h and 96h after the event, only urine samples are requested.
On this samples, IA and LC-GCMS according to the UNODOC standards ("Guidelines for the Forensic analysis of drugs facilitating sexual assault and other criminal acts") to objectify exogenous products.
On request of the patient, these results can be added to the medical file of the patient.
- Conditions
- Intoxication, Unintended Ingestion of Product
- Being tested
- serum and urine analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum and urine analysisDiagnostic test
Spiking will be analyzed by immunoassay testing and high-resolution screening
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the incidence of spiking in adult patients presenting to the emergency departments of the four Ghent hospitals with suspected spiking?
Number of patients presenting to the ED with spiking
Measured: 19 months
What is the type of product and mode of administration used in spiking
Defining type of products and mode of administration
Measured: 19 months
What are patient characteristics of patients with spiking
Demographic features of the patients diagnosed with spiking
Measured: 19 months
In what type of places does spiking occur in Ghent
Location of spiking event
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Jun 2023
- Primary completion31 Mar 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntoxicationStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207396
- Sponsor's protocol ID
- ONZ-2023-0004
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Spiking in Ghent: A Multicentric Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06207396
- Acronym / sponsor ID
- ONZ-2023-0004
- Conditions
- Intoxication, Unintended Ingestion of Product
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 17 Jan 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.
This study aims to document the incidence and characteristics of spiking in the Ghent region, both anamnestically and by toxicological analysis.
Spiking will be analyzed by immunoassay testing and high-resolution screening according to the protocol in the laboratory of UZ Gent;
Detailed description
This study aims at objectivating and characterizing the patients with alleged spiking in the city of Ghent.
Every patient who presents at one of the four (out of four) emergency departments of Ghent, with a suspicion of spiking (drink/food/needle-spiking included), will be offered to take part of this study.
The study entails a list of questions for the patient regarding demographics, recent own medication/drug/alcohol use and experienced symptoms; whilst the caregiver (doctor/nurse) completes a questionnaire regarding symptoms at time of presentation.
For a presentation within 48h after event, both blood and urine samples are requested from the patient. When presenting between 48h and 96h after the event, only urine samples are requested.
On this samples, IA and LC-GCMS according to the UNODOC standards ("Guidelines for the Forensic analysis of drugs facilitating sexual assault and other criminal acts") to objectify exogenous products.
On request of the patient, these results can be added to the medical file of the patient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population (18+, all genders) presenting with alleged spiking to the emergency department
Key inclusion criteria (3 listed)
- >18 years
- Patient self-reports suspicion of spiking OR there is a suspicion of spiking by physician, police, paramedics or patient's companions
- willingness to provide urine and/or blood samples (depending on timing after event)
Key exclusion criteria (6 listed)
- Reporting more than 5 days after spiking
- Unable to reliably complete the questionnaire (can be after clinical observation/recovery).
- Not declaring proficiency in the language in which informed consent is offered (Dutch/English).
- Not agreeing to the informed consent.
- Do not consent to blood and urine collection and/or analysis.
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 |
|---|---|---|
| serum and urine analysisSpiking will be analyzed by immunoassay testing and high-resolution screening | Diagnostic test | – |
Primary outcome
What is the incidence of spiking in adult patients presenting to the emergency departments of the four Ghent hospitals with suspected spiking?
Time frame: 19 months
Number of patients presenting to the ED with spiking
What is the type of product and mode of administration used in spiking
Time frame: 19 months
Defining type of products and mode of administration
What are patient characteristics of patients with spiking
Time frame: 19 months
Demographic features of the patients diagnosed with spiking
In what type of places does spiking occur in Ghent
Time frame: 19 months
Location of spiking event
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 7 Jan 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intoxication and Unintended Ingestion of Product, run by University Hospital, Ghent at 4 sites in Belgium.
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 3 inclusion and 6 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. 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?
What is the incidence of spiking in adult patients presenting to the emergency departments of the four Ghent hospitals with suspected spiking? (time frame: 19 months). The study lists 4 primary outcomes in all. 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 7 Jan 2026.