Efficacy of Semaglutide and Counselling in Reducing Craving and Use of Chemsex-Associated Drugs: An Open-Label Pilot Study

The primary objective is to evaluate the efficacy of weekly semaglutide administration in combination with regular counselling over a 20-week period to reduce craving for chemsex-associated drugs. The secondary objectives include the assessment of:

• Self-reported use of any chemsex-associated drug, specifically crystallized methamphetamine, cathinones, and GHB/GBL;
• Craving for crystallized methamphetamine, cathinones, GHB/GBL, and alcohol;
• Improvements in quality of life over 12 weeks;
• Frequency of adverse events.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients who are assigned male sex at birth and meet specific age requirements. Participants must meet the DSM-5 criteria for at least mild substance use disorder characterized by craving for and use of chemsex-related drugs. Inclusion requires a body mass index greater than 23 kg/m2 and the ability to provide informed consent.

This phase 2, open-label, single-center, non-controlled pilot clinical trial is designed to evaluate the efficacy of weekly semaglutide administration in conjunction with regular counselling sessions. The study aims to assess the reduction of craving and the use of chemsex-related drugs over a period of 20 weeks. Participants undergo a screening visit to determine eligibility based on criteria including substance use disorder diagnosis, age, sex, and body mass index. Following screening, the intervention period involves weekly subcutaneous injection of semaglutide at various doses and scheduled counselling. The primary endpoint is measured using the Penn Craving Score for specific substances. Secondary endpoints include self-reported drug use and quality of life assessments. The total duration of participant involvement is 20 weeks, including the initial screening and the final end-of-study procedures.

The experimental treatment consists of semaglutide, provided as a solution for injection in a pre-filled pen. Administration is conducted via subcutaneous injection at dosages of 0.25 mg, 0.5 mg, or 1 mg.

The study protocol includes regular counselling sessions as a concurrent intervention to be utilized alongside the pharmacological treatment over a 20-week period.

The efficacy of weekly semaglutide administration in combination with counseling is assessed through several endpoints. The primary endpoint is the craving for chemsex-related drugs, specifically measured as the highest craving score for cathinones, crystallized methamphetamine, or GHB/GBL. These assessments are conducted at baseline and during each subsequent study visit using the Penn Craving Score.

Secondary efficacy parameters include:

• Self-reported use of chemsex-related drugs, including crystallized methamphetamine, cathinones, and GHB/GBL.
• Craving for crystallized methamphetamine, cathinones, GHB/GBL, and alcohol at baseline and end of treatment.
• Quality of life at baseline and end of treatment.
• The sum of craving scores for cathinones, crystallized methamphetamine, and GHB/GBL at baseline and end of treatment, measured via a Visual Analogue Scale.