Glucagon-like peptide-1 analogues: a new way to quit smoking? (SKIP)-a structured summary of a study protocol for a randomized controlled study.

Autor: Lengsfeld S; Endocrinology, Diabetology and Metabolism, Department of Internal Medicine, University Hospital Basel, Petersgraben 4, 4031, Basel, Switzerland., Burkard T; Medical Outpatient Department, University Hospital Basel, Petersgraben 4, Basel, 4031, Switzerland.; Department of Cardiology, University Hospital Basel, Basel, Switzerland., Meienberg A; Medical Outpatient Department, University Hospital Basel, Petersgraben 4, Basel, 4031, Switzerland.; Faculty of Medicine, University of Basel, Basel, Switzerland., Jeanloz N; Endocrinology, Diabetology and Metabolism, Department of Internal Medicine, University Hospital Basel, Petersgraben 4, 4031, Basel, Switzerland., Coynel D; Division of Cognitive Neuroscience, Department of Psychology and Transfaculty Research Platform, University of Basel, Basel, Switzerland., Vogt DR; Endocrinology, Diabetology and Metabolism, Department of Internal Medicine, University Hospital Basel, Petersgraben 4, 4031, Basel, Switzerland.; Department of Clinical Research, University of Basel and University Hospital of Basel, Basel, Switzerland., Hemkens LG; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University of Basel and University Hospital of Basel, Basel, Switzerland.; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA.; Meta-Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Berlin, Germany., Speich B; Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University of Basel and University Hospital of Basel, Basel, Switzerland., Zanchi D; Roche Innovation Centre Basel, F. Hoffmann- La Roche, Basel, Switzerland.; Stanford University Graduate School of Business, Stanford, CA, USA., Erlanger TE; Department of Clinical Research, University of Basel and University Hospital of Basel, Basel, Switzerland., Christ-Crain M; Endocrinology, Diabetology and Metabolism, Department of Internal Medicine, University Hospital Basel, Petersgraben 4, 4031, Basel, Switzerland., Winzeler B; Endocrinology, Diabetology and Metabolism, Department of Internal Medicine, University Hospital Basel, Petersgraben 4, 4031, Basel, Switzerland. bettina.winzeler@usb.ch.
Jazyk: angličtina
Zdroj: Trials [Trials] 2023 Apr 20; Vol. 24 (1), pp. 284. Date of Electronic Publication: 2023 Apr 20.
DOI: 10.1186/s13063-023-07164-9
Abstrakt: Background: Cigarette smoking is the leading preventable cause of premature death. Despite dedicated programmes, quit rates remain low due to barriers such as nicotine withdrawal syndrome or post-cessation weight gain. Glucagon-like peptide-1 (GLP-1) analogues reduce energy intake and body weight and seem to modulate addictive behaviour. These GLP-1 properties are of major interest in the context of smoking cessation. The aim of this study is to evaluate the GLP-1 analogue dulaglutide as a new therapy for smoking cessation.
Methods: This is a placebo-controlled, double-blind, parallel group, superiority, single-centre randomized study including 255 patients. The intervention consists of a 12-week dulaglutide treatment phase with 1.5 mg once weekly or placebo subcutaneously, in addition to standard of care (behavioural counselling and pharmacotherapy with varenicline). A 40-week non-treatment phase follows. The primary outcome is the point prevalence abstinence rate at week 12. Smoking status is self-reported and biochemically confirmed by end-expiratory exhaled carbon monoxide measurement. Further endpoints include post-cessational weight gain, nicotine craving analysis, glucose homeostasis and long-term nicotine abstinence. Two separate substudies assess behavioural, functional and structural changes by functional magnetic resonance imaging and measures of energy metabolism (i.e. resting energy expenditure, body composition).
Discussion: Combining behavioural counselling and medical therapy, e.g. with varenicline, improves abstinence rates and is considered the standard of care. We expect a further increase in quit rates by adding a second component of medical therapy and assume a dual effect of dulaglutide treatment (blunting nicotine withdrawal symptoms and reducing post-cessational weight gain). This project is of high relevance as it explores novel treatment options aimed at preventing the disastrous consequences of nicotine consumption and obesity.
Trial Registration: ClinicalTrials.gov NCT03204396 . Registered on June 26, 2017.
(© 2023. The Author(s).)
Databáze: MEDLINE
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