Christina A Brezing, Mohammad Sibai, C Jean Choi, Souparno Mitra, John J Mariani, Nasir Naqvi, Amy L Mahony, Daniel Brooks, Martina Pavlicova, Frances R Levin
{"title":"lorcaserin（一种5-羟色胺2C受体激动剂）治疗大麻使用障碍的开放性先导试验","authors":"Christina A Brezing, Mohammad Sibai, C Jean Choi, Souparno Mitra, John J Mariani, Nasir Naqvi, Amy L Mahony, Daniel Brooks, Martina Pavlicova, Frances R Levin","doi":"10.1080/14659891.2023.2202760","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objective: </strong>Cannabis Use Disorder (CUD) has no FDA approved treatment. Serotonin-2c (5HT2c) agonists have preclinical and human laboratory evidence for potential efficacy for CUD. We assessed the tolerability and effects of lorcaserin (5HT2c agonist) on CUD.</p><p><strong>Methods: </strong>In a 10-week, open label, uncontrolled trial, the tolerability of lorcaserin was tested in outpatients with CUD. Adverse events (AE) were assessed weekly. Cannabis use was assessed twice weekly by the Timeline follow-back and quantitative urine metabolites.</p><p><strong>Results: </strong>17 participants enrolled, and 14 received medication. Participants' average age was 35 years; majority were male (N=12). The medication was well tolerated in males. There were no serious adverse events (SAE). The most common AE's were headache/migraine (N=4, all females), anorexia (N=3), and irritability (N=2). Participants decreased their frequency of cannabis use significantly (p < 0.001), adjusted for baseline use. By the end of the trial, participants decreased by 1.76 (SE=0.47) cannabis using days/week. Average daily amount of cannabis and urine THC metabolite levels did not change significantly.</p><p><strong>Conclusions: </strong>Lorcaserin was well tolerated in males but not females suggesting possible sex differences. Future trials of other 5HT2c agonists (lorcaserin was withdrawn at the request of the FDA) should consider longer dose titration phases.</p><p><strong>Trial registration: </strong>NCT02932215.</p>","PeriodicalId":17097,"journal":{"name":"Journal of Substance Use","volume":null,"pages":null},"PeriodicalIF":0.6000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11250997/pdf/","citationCount":"0","resultStr":"{\"title\":\"Open Label Pilot of Lorcaserin (a serotonin 2C-receptor agonist) for Cannabis Use Disorder.\",\"authors\":\"Christina A Brezing, Mohammad Sibai, C Jean Choi, Souparno Mitra, John J Mariani, Nasir Naqvi, Amy L Mahony, Daniel Brooks, Martina Pavlicova, Frances R Levin\",\"doi\":\"10.1080/14659891.2023.2202760\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and objective: </strong>Cannabis Use Disorder (CUD) has no FDA approved treatment. Serotonin-2c (5HT2c) agonists have preclinical and human laboratory evidence for potential efficacy for CUD. We assessed the tolerability and effects of lorcaserin (5HT2c agonist) on CUD.</p><p><strong>Methods: </strong>In a 10-week, open label, uncontrolled trial, the tolerability of lorcaserin was tested in outpatients with CUD. Adverse events (AE) were assessed weekly. Cannabis use was assessed twice weekly by the Timeline follow-back and quantitative urine metabolites.</p><p><strong>Results: </strong>17 participants enrolled, and 14 received medication. Participants' average age was 35 years; majority were male (N=12). The medication was well tolerated in males. There were no serious adverse events (SAE). The most common AE's were headache/migraine (N=4, all females), anorexia (N=3), and irritability (N=2). Participants decreased their frequency of cannabis use significantly (p < 0.001), adjusted for baseline use. By the end of the trial, participants decreased by 1.76 (SE=0.47) cannabis using days/week. Average daily amount of cannabis and urine THC metabolite levels did not change significantly.</p><p><strong>Conclusions: </strong>Lorcaserin was well tolerated in males but not females suggesting possible sex differences. Future trials of other 5HT2c agonists (lorcaserin was withdrawn at the request of the FDA) should consider longer dose titration phases.</p><p><strong>Trial registration: </strong>NCT02932215.</p>\",\"PeriodicalId\":17097,\"journal\":{\"name\":\"Journal of Substance Use\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.6000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11250997/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Substance Use\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/14659891.2023.2202760\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/5/10 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"SUBSTANCE ABUSE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Substance Use","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14659891.2023.2202760","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/5/10 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"SUBSTANCE ABUSE","Score":null,"Total":0}
Open Label Pilot of Lorcaserin (a serotonin 2C-receptor agonist) for Cannabis Use Disorder.
Background and objective: Cannabis Use Disorder (CUD) has no FDA approved treatment. Serotonin-2c (5HT2c) agonists have preclinical and human laboratory evidence for potential efficacy for CUD. We assessed the tolerability and effects of lorcaserin (5HT2c agonist) on CUD.
Methods: In a 10-week, open label, uncontrolled trial, the tolerability of lorcaserin was tested in outpatients with CUD. Adverse events (AE) were assessed weekly. Cannabis use was assessed twice weekly by the Timeline follow-back and quantitative urine metabolites.
Results: 17 participants enrolled, and 14 received medication. Participants' average age was 35 years; majority were male (N=12). The medication was well tolerated in males. There were no serious adverse events (SAE). The most common AE's were headache/migraine (N=4, all females), anorexia (N=3), and irritability (N=2). Participants decreased their frequency of cannabis use significantly (p < 0.001), adjusted for baseline use. By the end of the trial, participants decreased by 1.76 (SE=0.47) cannabis using days/week. Average daily amount of cannabis and urine THC metabolite levels did not change significantly.
Conclusions: Lorcaserin was well tolerated in males but not females suggesting possible sex differences. Future trials of other 5HT2c agonists (lorcaserin was withdrawn at the request of the FDA) should consider longer dose titration phases.
期刊介绍：
Journal of Substance Use is a bimonthly international journal, publishing peer-reviewed, up-to-the-minute articles on a wide spectrum of issues relating to the use of legal and illegal substances. The Journal aims to educate, inform, update and act as a forum for standard setting for health and social care professionals working with individuals and families with substance use problems. It also informs and supports those undertaking research in substance use, developing substance use services, and participating in, leading and developing education and training programmes.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
