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A study testing semaglutide with counselling to reduce cravings and use of chemsex-related drugs in adults who use these substances

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at craving for and use of drugs associated with chemsex, which refers to the use of certain substances during sexual activity. The treatment being tested is semaglutide, which is given as a weekly injection under the skin using a pre-filled pen. The study will use three different strengths of semaglutide: 0.25 mg, 0.5 mg, and 1 mg. Participants will also receive regular counselling sessions along with the medication. The purpose of this study is to assess if the weekly use of semaglutide combined with counselling over 20 weeks can reduce the craving for drugs associated with chemsex.

The study will focus on craving and use of specific drugs including cathinones, crystallized methamphetamine, and GHB/GBL. These substances are sometimes used in chemsex settings. The study will measure how strong the craving is for these drugs and how often they are used by participants. It will also look at craving for alcohol and overall quality of life. The study is designed for people assigned male sex at birth who are 18 years or older and who meet certain criteria for substance use disorder.

During the study, participants will receive semaglutide injections once a week along with counselling sessions. The treatment period will last for several weeks, with different dosing schedules depending on the strength of semaglutide being used. Throughout the study, participants will be asked about their craving levels and drug use at each visit. The study will also monitor any side effects that may occur while taking semaglutide. The study is expected to begin enrolling participants in 2026 and will be completed by 2027.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment initiation and baseline assessment

    At the start of the trial, your baseline measurements will be recorded. This includes an assessment of your craving for substances associated with chemsex using the Penn Craving Score, which measures how strong your desire for these substances is.

    Your craving will be assessed for specific substances including cathinones (stimulant drugs), crystallized methamphetamine (a type of stimulant), GHB/GBL (depressant substances), and alcohol.

    Your quality of life will also be evaluated at this stage.

    You will report your current use of the substances mentioned above.

    You will begin receiving semaglutide injections. Semaglutide is a medication that will be given to you as an injection under the skin.

  2. Step 2

    Weekly medication administration

    You will receive semaglutide injections once per week throughout the treatment period.

    The medication is administered as a subcutaneous injection, which means it is injected under the skin using a pre-filled pen.

    The dosage may vary and will be determined based on the treatment protocol. Available dosages include 0.25 mg, 0.5 mg, or 1 mg per injection.

  3. Step 3

    Regular counselling sessions

    Throughout the 20-week treatment period, you will attend regular counselling sessions.

    These sessions are part of the treatment approach and will be combined with your weekly medication.

  4. Step 4

    Ongoing craving assessments at study visits

    At each study visit during the treatment period, your craving for substances will be assessed using the Penn Craving Score.

    This will include measuring your craving for cathinones, crystallized methamphetamine, and GHB/GBL.

    Your craving will also be measured using a Visual Analogue Scale (VAS), which is a simple rating scale where you indicate the intensity of your craving.

    You will continue to report your use of crystallized methamphetamine, cathinones, and GHB/GBL at these visits.

  5. Step 5

    Safety monitoring throughout treatment

    Throughout the study, any side effects you experience will be monitored using the SAFTEE form, which is a standardized questionnaire for tracking adverse effects.

    You will be asked to report any side effects, and particular attention will be given to those classified as grade 3 to 5, which represent more serious reactions.

  6. Step 6

    End of treatment assessment

    At the end of the 20-week treatment period, final assessments will be conducted.

    Your craving for crystallized methamphetamine, cathinones, GHB/GBL, and alcohol will be measured and compared to your baseline measurements.

    Your quality of life will be assessed again to determine any changes from the beginning of the trial.

    The total craving score, which combines your craving for cathinones, crystallized methamphetamine, and GHB/GBL, will be calculated.

Who can join the trial?

6 criteria

  • You must be able and willing to give your informed consent, which means you agree to join the study after understanding all the details about it
  • You must be 18 years old or older
  • You must have been assigned male sex at birth
  • You must meet the criteria for at least mild substance use disorder during the screening visit, which means a pattern of using drugs that causes some problems in your life, as defined by a medical classification system called DSM-5
  • Your BMI must be greater than 23, where BMI stands for body mass index, which is a measurement that uses your height and weight to estimate body fat
  • You must be willing to take the study medication and complete all study procedures

Who cannot join the trial?

12 criteria

  • Women cannot participate in this study
  • People who have a known allergy, which means a bad reaction of the body's defense system, to semaglutide, which is the study medicine, or any of its ingredients
  • People who have type 1 diabetes, which is a condition where the body cannot produce insulin, a substance that controls blood sugar levels
  • People who have had pancreatitis, which is an inflammation or swelling of the pancreas, an organ that helps digest food
  • People who have a personal or family history of medullary thyroid cancer, which is a specific type of cancer affecting the thyroid gland in the neck
  • People who have Multiple Endocrine Neoplasia syndrome type 2, which is a rare inherited condition that causes tumors in certain glands of the body
  • People who have severe kidney disease, which means the kidneys, organs that filter waste from the blood, are not working properly
  • People who have severe liver disease, which means the liver, an organ that cleans the blood and helps digest food, is not working properly
  • People who are currently using other medicines for weight loss
  • People who have had weight loss surgery in the past
  • People who have serious mental health conditions that are not well controlled
  • People who are currently participating in another research study
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Investigated drugs

Semaglutide is a medication that is usually used to treat type 2 diabetes and to help with weight loss. In this trial, it is being tested to see if it can help reduce cravings for certain drugs used in chemsex. The medication is given once a week and is used together with regular counseling sessions.

What is already known about the treatment

Semaglutide – Semaglutide is a medication given as a weekly injection under the skin that is currently approved for treating type 2 diabetes and obesity by helping to control blood sugar levels and reduce appetite. It works by mimicking a natural hormone called GLP-1 that affects areas of the brain involved in regulating appetite and reward pathways, which may also influence cravings for addictive substances. In this clinical trial, researchers are exploring whether semaglutide, when combined with regular counseling sessions, can help reduce cravings for and use of drugs associated with chemsex (recreational drug use during sexual activity). This represents an experimental use of the medication, as it is being studied for a new purpose beyond its current approved indications in diabetes and weight management.

Investigated diseases

Substance Use Disorder – This condition involves the repeated use of drugs despite harmful consequences and difficulty controlling their use. People with this disorder experience strong cravings or urges to use specific substances, which can interfere with daily activities and relationships. The pattern typically includes using larger amounts over time, unsuccessful attempts to cut down, and spending significant time obtaining or recovering from the substance. The disorder progresses as the brain adapts to repeated drug exposure, making it harder to feel pleasure from normal activities. Social and occupational functioning often deteriorates as substance use becomes a central focus of daily life. The condition can involve various substances including stimulants and depressants that affect brain chemistry and behavior.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524177-16-00Estimated enrolment22 patientsSponsorInstitute Of Tropical Medicine

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