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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institute Of Tropical Medicine

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]

Decision date (initial)

2026-02-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Assess if the weekly use of semaglutide, combined with counselling over 20 weeks can reduce the craving for CADs

Secondary objectives 11

1. Assess if the weekly use of semaglutide, combined with counselling over 20 weeks can reduce the self-reported use of any CAD
2. Assess if the weekly use of semaglutide, combined with counselling over 20 weeks can reduce the self-reported use of crystallized methamphetamine
3. Assess if the weekly use of semaglutide, combined with counselling over 20 weeks can reduce the self-reported use of cathinones
4. Assess if the weekly use of semaglutide, combined with counselling over 20 weeks can reduce the self-reported use of GHB/GBL
5. Assess if the weekly use of semaglutide, combined with counselling over 20 weeks can reduce the craving for crystallized methamphetamine
6. Assess if the weekly use of semaglutide, combined with counselling over 20 weeks can reduce the craving for cathinones
7. Assess if the weekly use of semaglutide, combined with counselling over 20 weeks can reduce the craving for GHB/GBL
8. Assess if the weekly use of semaglutide, combined with counselling over 20 weeks can reduce the craving for alcohol
9. Assess if if the weekly use of semaglutide, combined with counselling over 20 weeks can improve quality of life over 12 weeks
10. Assess if the weekly use of semaglutide, combined with counselling over 20 weeks can reduce the craving for CADs
11. Assess the frequency of adverse events during use of semaglutide

Conditions and MedDRA coding

Craving for and use of chemsex-related drugs

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Able and willing to provide informed consent
2. Aged 18 years or older
3. Assigned male sex at birth
4. Meeting the DSM-5 criteria for at least ‘mild substance use disorder’ at screening
5. BMI >23 kg/m2
6. Willingness to take study medication and complete study procedures

Exclusion criteria 7

1. Hypersensitivity to semaglutide or any substance used in the IMP
2. Prior use of semaglutide or other GLP-1 agonists
3. 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
4. A personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B
5. Uncontrolled thyroid disease at screening
6. Uncontrolled hypertension or systolic BP >180 mmHg and/or diastolic BP >110 mmHg, averaged from three measurements
7. Elevation of serum lipase, conjugated bilirubin, or alkaline phosphatase (ALP), ALT, more than 3 times the upper limit of normal on baseline bloodwork

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 11

1. Self-reported use CADs
2. Self-reported use crystallized methamphetamine
3. Self-reported use cathinones
4. Self-reported use GHB/GBL
5. Craving for crystallized methamphetamine at baseline and end of treatment
6. Craving for cathinones at baseline and end of treatment
7. Craving for GHB/GBL at baseline and end of treatment
8. Craving for alcohol at baseline and end of treatment
9. Quality of life at baseline and end of treatment
10. Craving for CADs (sum of craving for cathinones + crystallized methamphetamine + GHB/GBL) at baseline and end of treatment (VAS)
11. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institute Of Tropical Medicine

Sponsor organisation

Institute Of Tropical Medicine

Address

Nationalestraat 155

City

Antwerp

Postcode

2000

Country

Belgium

Scientific contact point

Organisation

Institute Of Tropical Medicine

Contact name

Clinical Trial Unit

Public contact point

Organisation

Institute Of Tropical Medicine

Contact name

Clinical Trial Unit

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 28 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications