Characteristics of (Unwanted) Use of Alcohol and Illicit Substances Among Patients Reporting After Sexual Violence in Ghent: a Mono-centric Prospective Observational 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.

Study Overview

• Status: Completed
• Conditions: Drug-facilitated Sexual Assault
• Intervention / Treatment: Diagnostic test: urine/blood analysis with IA and LC-GCMS analysis

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 Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • ZSG UZ Gent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Victims of DFSA (16+)

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
victims of DFSA; Every patients presenting at the sexual assault care centre with a suspicion of drug-assisted sexual assault	Diagnostic test: urine/blood analysis with IA and LC-GCMS analysis; urine/blood analysis with IA and LC-GCMS analysis; Other Names: toxicology testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient characteristics in objectivated DFSA	Characteristics of patients (medical history, symptoms) after DFSA	19 months
toxicology results in patients with DFSA	Results of toxicologic analysis in patients with DFSA	19 months

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Reproductive and Urinary Physiological Phenomena; Urinary Tract Physiological Phenomena; Hematologic Tests; Urination
• Other Study ID Numbers: ONZ-2023-0076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No