Semaglutide for Substance use disorder (chemsex-related drugs)

Inclusion criteria

• {"criterion_text":"- Able and willing to provide informed consent\n- Aged 18 years or older\n- Assigned male sex at birth\n- Meeting the DSM-5 criteria for at least ‘mild substance use disorder’ at screening\n- BMI >23 kg/m2\n- Willingness to take study medication and complete study procedures"}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to semaglutide or any substance used in the IMP\n- Prior use of semaglutide or other GLP-1 agonists\n- Past 30-day use or current use of: Sulfonylureas, insulin and insulin products, weight control medications or other medications that may interact with semaglutide or are not compatible with semaglutide intake based on the investigator's opinion\n- A personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B\n- Uncontrolled thyroid disease at screening\n- Uncontrolled hypertension or systolic BP >180 mmHg and/or diastolic BP >110 mmHg, averaged from three measurements\n- Elevation of serum lipase, conjugated bilirubin, or alkaline phosphatase (ALP), ALT, more than 3 times the upper limit of normal on baseline bloodwork"}

Primary endpoints

• {"endpoint_text":"- Craving for CADs (the highest craving score for cathinones / crystallized methamphetamine / GHB/GBL) at baseline and each subsequent study visit (Penn Craving Score)","definition_or_measurement_approach":"Measured using the Penn Craving Score; highest craving score for cathinones, crystallized methamphetamine and GHB/GBL recorded at baseline and each subsequent study visit."}

Secondary endpoints

• {"endpoint_text":"- Self-reported use CADs","definition_or_measurement_approach":"Self-reported use of chemsex-associated drugs (CADs) collected via questionnaires."}
• {"endpoint_text":"- Self-reported use crystallized methamphetamine","definition_or_measurement_approach":"Self-reported use collected via questionnaires."}
• {"endpoint_text":"- Self-reported use cathinones","definition_or_measurement_approach":"Self-reported use collected via questionnaires."}
• {"endpoint_text":"- Self-reported use GHB/GBL","definition_or_measurement_approach":"Self-reported use collected via questionnaires."}
• {"endpoint_text":"- Craving for crystallized methamphetamine at baseline and end of treatment","definition_or_measurement_approach":"Craving measured at baseline and end of treatment (instrument not further specified)."}
• {"endpoint_text":"- Craving for cathinones at baseline and end of treatment","definition_or_measurement_approach":"Craving measured at baseline and end of treatment."}
• {"endpoint_text":"- Craving for GHB/GBL at baseline and end of treatment","definition_or_measurement_approach":"Craving measured at baseline and end of treatment."}
• {"endpoint_text":"- Craving for alcohol at baseline and end of treatment","definition_or_measurement_approach":"Craving measured at baseline and end of treatment."}
• {"endpoint_text":"- Quality of life at baseline and end of treatment","definition_or_measurement_approach":"Quality of life measured at baseline and end of treatment (instrument not specified)."}
• {"endpoint_text":"- Craving for CADs (sum of craving for cathinones + crystallized methamphetamine + GHB/GBL) at baseline and end of treatment (VAS)","definition_or_measurement_approach":"Sum score of cravings for specified substances measured on a Visual Analogue Scale (VAS) at baseline and end of treatment."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Safety assessed using the SAFTEE form; cumulative proportion reporting grade 3-5 adverse events over study duration."}

Belgium

Earliest CTIS Part Ii Submission Date

23-01-2026

Latest Decision Or Authorization Date

12-02-2026

Processing Time Days

20

Number Of Sites

1

Number Of Participants

22

Primary sponsor

Full Name

Institute Of Tropical Medicine

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium