Does semaglutide reduce alcohol intake in Danish patients with alcohol use disorder and comorbid obesity? Trial protocol of a randomised, double-blinded, placebo-controlled clinical trial (the SEMALCO trial).

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Tác giả: Helene Benveniste, Claus Thorn Ekstrøm, Anders Fink-Jensen, Jens Juul Holst, Signe Keller Justesen, Mette Kruse Klausen, Ulla B Knorr, Gitte M Knudsen, George Koob, Tugba Kuzey, Graeme Mason, Julie Niemann Pedersen, Line Rasmussen, Tina Vilsbøll, Nora D Volkow

Ngôn ngữ: eng

Ký hiệu phân loại: 972.8202 *Central America

Thông tin xuất bản: England : BMJ open , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 90153

INTRODUCTION: Alcohol use disorder (AUD) is a massive burden for the individual, relatives and society. Despite this, the treatment gap is wide compared with other mental health disorders. Treatment options are sparse, with only three Food and Drug Administration (FDA)-approved pharmacotherapies. Glucagon-like peptide-1 (GLP-1) receptor agonists have shown promising effects in reducing alcohol consumption in preclinical experiments, and clinical trials are in high demand to investigate these potentially beneficial effects in patients diagnosed with AUD. METHODS AND ANALYSIS: The effects of the once-weekly GLP-1 receptor agonist semaglutide will be investigated in a 26-week, randomised, placebo-controlled, double-blinded clinical trial. 108 patients diagnosed with AUD and comorbid obesity (body mass index (BMI)≥30 kg/m STATUS: Recruitment started in June 2023. ETHICS AND DISSEMINATION: The study is approved by the Ethics Committee of the Capital Region of Denmark, the Danish Board of Health and the Danish Data Protection Agency. All patients will sign the written consent form before being included in the trial. Results will be disseminated through peer-reviewed publications and conference presentations. After the results are published, all de-identified data will be available in the Mendeley database. TRIAL REGISTRATION NUMBER: NCT05895643.
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