Drug-facilitated Sexual AssaultNCT06188780
Characteristics of (Unwanted) Use of Alcohol and Illicit Substances Among Patients Reporting After Sexual Violence in Ghent: a Mono-centric Prospective Observational Study
An observational study of Drug-facilitated Sexual Assault, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study aims at defining the patient characteristics and toxicological aspects of patients presenting at the sexual assault care centre with drugs-facilitated sexual assault. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Drug-facilitated Sexual Assault
- What is being tested?
- urine/blood analysis with IA and LC-GCMS analysis
- How many people
- 114 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2023to 31 Mar 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Victims of DFSA (16+)
Who may be able to join
- All patients (16+) who registered at the Care Center after Sexual Violence (=ZSG) in Ghent from 01/04/2023 until. 31/03/2025 and who were victims of sexual violence are eligible for inclusion in this study.
Who cannot join
- Reporting longer than 5 days after the sexual assault.
- Unable to undergo a forensic examination under the supervision of a forensic nurse due to, for example, collapse of consciousness or failure to give consent to do so.
- Not declaring proficiency in the language in which informed consent is offered (Dutch/English)
- Not agreeing to the informed consent.
- Not agreeing to collection and/or analysis of blood and urine.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims at defining the patient characteristics and toxicological aspects of patients presenting at the sexual assault care centre with drugs-facilitated sexual assault.
Read the detailed description
This study aims to map (un)voluntary use of alcohol and drugs among victims of sexual violence who present to the Care Centre after Sexual Violence at UZ Gent, referred to in English as Drug-Facilitated Sexual Assault (DFSA).
Sometimes substances are deliberately used to render a victim submissive (proactive DFSA), but it is also possible that people use substances themselves recreationally and later become victims of sexual violence (opportunistic DFSA).
Recent media reports of drinks in which psychogenic substances are involuntarily administered have become more frequent, after which people sometimes become victims of sexual violence. The public attention for this problem increased significantly recently. However, no clear data are currently available in Belgium on this problem.
Using a prospective observational study, we aim to map the incidence of (unwanted) use of alcohol and illegal substances among victims who report to the Care Centre after Sexual Violence in Ghent. The data - after obtaining informed consent - will be collected by means of (nurse-led) questionnaires and toxicological analyses on blood and urine samples. We envisage a two-year period for inclusion of patients, starting from 01/03/2023, running until 31/03/2025.
With these results, we want to estimate the proportion of sexual assault incidents in which the victim was incapacitated by voluntary or involuntary/unwanted use of alcohol or illicit substances (e.g. cannabis, GHB, cocaine, ...). To this end, we need to record data from all patients who present in order to estimate the denominator.
Every patients presenting at the sexual assault care centre with a suspicion of drug-assisted sexual assault, will be requested to take part in the study.
Patient data will be derived from the patient record, with regards to voluntary and unvoluntary administration of alcohol/illicit drugs/medication, previous medical history and symptoms.
Biological samples (blood and urine if <48h after event, and urine if between 48h and 96h after event) will be collected and analysed according to UNODC guidelines (Guidelines for the Forensic analysis of drugs facilitating sexual assault and other criminal acts) with IA and LC-GCMS testing.
- Conditions
- Drug-facilitated Sexual Assault
- Being tested
- urine/blood analysis with IA and LC-GCMS analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine/blood analysis with IA and LC-GCMS analysisDiagnostic test
Also called toxicology testing
urine/blood analysis with IA and LC-GCMS analysis
| Study group | Role | What they receive |
|---|---|---|
| victims of DFSA | Every patients presenting at the sexual assault care centre with a suspicion of drug-assisted sexual assault Receives: Diagnostic Test: urine/blood analysis with IA and LC-GCMS analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient characteristics in objectivated DFSA
Characteristics of patients (medical history, symptoms) after DFSA
Measured: 19 months
toxicology results in patients with DFSA
Results of toxicologic analysis in patients with DFSA
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 posted3 Jan 2024
- Study start1 Jun 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-facilitated Sexual AssaultStudies 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
- 114 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
- NCT06188780
- Sponsor's protocol ID
- ONZ-2023-0076
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 (Unwanted) Use of Alcohol and Illicit Substances Among Patients Reporting After Sexual Violence in Ghent: a Mono-centric Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06188780
- Acronym / sponsor ID
- ONZ-2023-0076
- Conditions
- Drug-facilitated Sexual Assault
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 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 Mar 2025 (actual)
- First posted
- 3 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 at defining the patient characteristics and toxicological aspects of patients presenting at the sexual assault care centre with drugs-facilitated sexual assault.
Detailed description
This study aims to map (un)voluntary use of alcohol and drugs among victims of sexual violence who present to the Care Centre after Sexual Violence at UZ Gent, referred to in English as Drug-Facilitated Sexual Assault (DFSA).
Sometimes substances are deliberately used to render a victim submissive (proactive DFSA), but it is also possible that people use substances themselves recreationally and later become victims of sexual violence (opportunistic DFSA).
Recent media reports of drinks in which psychogenic substances are involuntarily administered have become more frequent, after which people sometimes become victims of sexual violence. The public attention for this problem increased significantly recently. However, no clear data are currently available in Belgium on this problem.
Using a prospective observational study, we aim to map the incidence of (unwanted) use of alcohol and illegal substances among victims who report to the Care Centre after Sexual Violence in Ghent. The data - after obtaining informed consent - will be collected by means of (nurse-led) questionnaires and toxicological analyses on blood and urine samples. We envisage a two-year period for inclusion of patients, starting from 01/03/2023, running until 31/03/2025.
With these results, we want to estimate the proportion of sexual assault incidents in which the victim was incapacitated by voluntary or involuntary/unwanted use of alcohol or illicit substances (e.g. cannabis, GHB, cocaine, ...). To this end, we need to record data from all patients who present in order to estimate the denominator.
Every patients presenting at the sexual assault care centre with a suspicion of drug-assisted sexual assault, will be requested to take part in the study.
Patient data will be derived from the patient record, with regards to voluntary and unvoluntary administration of alcohol/illicit drugs/medication, previous medical history and symptoms.
Biological samples (blood and urine if <48h after event, and urine if between 48h and 96h after event) will be collected and analysed according to UNODC guidelines (Guidelines for the Forensic analysis of drugs facilitating sexual assault and other criminal acts) with IA and LC-GCMS testing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| victims of DFSA | – | Diagnostic Test: urine/blood analysis with IA and LC-GCMS analysisEvery patients presenting at the sexual assault care centre with a suspicion of drug-assisted sexual assault |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Victims of DFSA (16+)
Key inclusion criteria (1 listed)
- All patients (16+) who registered at the Care Center after Sexual Violence (=ZSG) in Ghent from 01/04/2023 until. 31/03/2025 and who were victims of sexual violence are eligible for inclusion in this study.
Key exclusion criteria (5 listed)
- Reporting longer than 5 days after the sexual assault.
- Unable to undergo a forensic examination under the supervision of a forensic nurse due to, for example, collapse of consciousness or failure to give consent to do so.
- Not declaring proficiency in the language in which informed consent is offered (Dutch/English)
- Not agreeing to the informed consent.
- Not agreeing to collection and/or analysis of blood and urine.
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 |
|---|---|---|
| urine/blood analysis with IA and LC-GCMS analysisAlso: toxicology testingurine/blood analysis with IA and LC-GCMS analysis | Diagnostic test | victims of DFSA |
Primary outcome
patient characteristics in objectivated DFSA
Time frame: 19 months
Characteristics of patients (medical history, symptoms) after DFSA
toxicology results in patients with DFSA
Time frame: 19 months
Results of toxicologic analysis in patients with DFSA
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.
- Individual participant dataSharing planned: Undecided
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 Drug-facilitated Sexual Assault, run by University Hospital, Ghent at 1 site 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 1 inclusion and 5 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 1 site 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?
patient characteristics in objectivated DFSA (time frame: 19 months). The study lists 2 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.