2025-524177-16-00招募中2 期
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.
Institute Of Tropical Medicine1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2026年2月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Craving for CADs (the highest craving score for cathinones / crystallized methamphetamine / GHB/GBL) at baseline and each subsequent study visit (Penn Craving Score)
研究概览
简要总结
Assess if the weekly use of semaglutide, combined with counselling over 20 weeks can reduce the craving for CADs
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide informed consent
- •Aged 18 years or older
- •Assigned male sex at birth
- •Meeting the DSM-5 criteria for at least ‘mild substance use disorder’ at screening
- •BMI >23 kg/m2
- •Willingness to take study medication and complete study procedures
排除标准
- •Hypersensitivity to semaglutide or any substance used in the IMP
- •Prior use of semaglutide or other GLP-1 agonists
- •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
- •A personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B
- •Uncontrolled thyroid disease at screening
- •Uncontrolled hypertension or systolic BP >180 mmHg and/or diastolic BP >110 mmHg, averaged from three measurements
- •Elevation of serum lipase, conjugated bilirubin, or alkaline phosphatase (ALP), ALT, more than 3 times the upper limit of normal on baseline bloodwork
结局指标
主要结局
Craving for CADs (the highest craving score for cathinones / crystallized methamphetamine / GHB/GBL) at baseline and each subsequent study visit (Penn Craving Score)
Craving for CADs (the highest craving score for cathinones / crystallized methamphetamine / GHB/GBL) at baseline and each subsequent study visit (Penn Craving Score)
次要结局
- Self-reported use cathinones
- Self-reported use CADs
- Self-reported use crystallized methamphetamine
- 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
研究者
Clinical Trial Unit
Scientific
Institute Of Tropical Medicine
研究点 (1)
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