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Clinical Trials in the EU / 2025-524177-16-00
Authorised, recruiting Phase II

An open-label, single-center, non-controlled pilot clinical trial to assess the efficacy of weekly semaglutide in combination with regular counselling sessions to reduce craving and use of chemsex associated drugs (CoSem4Chemsex) study.

2025-524177-16-00 · tracked via the Priya Life Science EU tracker
Sponsor
Institute Of Tropical Medicine
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Behavior and Behavior Mechanisms
Decision date
12/02/2026
Enrollment target
22
Sites
Belgium

Condition studied

Craving for and use of chemsex-related drugs

Investigational medicinal product(s)

Ozempic 0.25 mg solution for injection in pre-filled penOzempic 0.5 mg solution for injection in pre-filled penOzempic 1 mg solution for injection in pre-filled pen

Eligibility

Age group
65+ years, 18-64 years
Sex
Male

Primary endpoint

Craving for CADs (the highest craving score for cathinones / crystallized methamphetamine / GHB/GBL) at baseline and each subsequent study visit (Penn Craving Score)

Endpoint detail

Self-reported use CADs, Self-reported use crystallized methamphetamine, Self-reported use cathinones, Self-reported use GHB/GBL, Craving for crystallized methamphetamine at baseline and end of treatment, Craving for cathinones at baseline and end of treatment, Craving for GHB/GBL at baseline and end of treatment, Craving for alcohol at baseline and end of treatment, Quality of life at baseline and end of treatment, Craving for CADs (sum of craving for cathinones + crystallized methamphetamine + GHB/GBL) at baseline and end of treatment (VAS), The cumulative proportion of participants reporting grade 3 to 5 of each side effect listed in the SAFTEE form over the course of the study whilst receiving semaglutide

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524177-16-00 on CTIS ↗ ← All trials in the EU