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Completed

NCT Number: NCT06188780

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ZSG UZ Gent

Ghent, 9000, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

urine/blood analysis with IA and LC-GCMS analysis

Diagnostic Test

urine/blood analysis with IA and LC-GCMS analysis

Other names: toxicology testing

Primary outcomes

  1. patient characteristics in objectivated DFSA

    Time frame: 19 months

    Characteristics of patients (medical history, symptoms) after DFSA

  2. toxicology results in patients with DFSA

    Time frame: 19 months

    Results of toxicologic analysis in patients with DFSA

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.