Characteristics of Spiking in Ghent: a Multicentric Prospective Observational Study..

January 4, 2024 updated by: University Hospital, Ghent

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;

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Gent, Belgium, 9000
      • Gent, Belgium, 9000
      • Gent, Belgium, 9000
        • Recruiting
        • Spoedgevallendienst AZ St. Lucas
        • Contact:
          • Philippe Leune, MD
      • Gent, Belgium, 9000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult population (18+, all genders) presenting with alleged spiking to the emergency department

Description

Inclusion Criteria:

  • >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)

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
19 months
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
19 months
What are patient characteristics of patients with spiking
Time Frame: 19 months
Demographic features of the patients diagnosed with spiking
19 months
In what type of places does spiking occur in Ghent
Time Frame: 19 months
Location of spiking event
19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ONZ-2023-0004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intoxication

Clinical Trials on serum and urine analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe