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)

Jan 8, 2025BMJ open

Does semaglutide lower alcohol drinking in Danish patients with alcohol use disorder and obesity? A plan for a blinded, placebo-controlled trial

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Abstract

108 patients diagnosed with and obesity will participate in a 26-week trial of the semaglutide.

Participants will be randomized to receive either semaglutide or a placebo alongside cognitive behavioral therapy.
The primary outcome will focus on the reduction in heavy drinking days, defined as exceeding 48 grams of alcohol per day for women and 60 grams for men.
Secondary outcomes will include changes in overall alcohol consumption, smoking status, quality of life, and various neurochemical and brain imaging metrics.
Brain imaging will assess structural, functional, and neurochemical changes at baseline and after 26 weeks of treatment.
Recruitment for the trial began in June 2023.

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INTRODUCTION: (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 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)) will be randomised to treatment with either semaglutide or placebo in combination with cognitive behavioural therapy. A subgroup of the patients will have structural, functional and neurochemical brain imaging performed at baseline and after 26 weeks of treatment.is the reduction in heavy drinking days, defined as days with excess consumption of 48/60 g of alcohol per day (women and men, respectively).include changes from baseline to week 26 in alcohol consumption, smoking status, quality of life, fibrosis-4 score, plasma concentration of phosphatidylethanol, brain gamma-aminobutyric acid (GABA) levels, alcohol cue reactivity, functional connectivity and white matter tract integrity. 2The primary endpoint Secondary endpoints

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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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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