Abstract

Background

The number of people with an alcohol use disorder (AUD) was recently estimated to be 63.5 million worldwide. The global burden of disease and injury attributable to alcohol is considerable: about 3 million deaths, namely one in 20, were caused by alcohol in 2015. At the same time, AUD remains seriously undertreated.

In this context, alternative or adjunctive therapies such as brain stimulation could play an important role. The early results of studies using repetitive transcranial magnetic stimulation (rTMS) suggest that stimulations delivered to the dorsolateral prefrontal cortex significantly reduce cravings and improve decision-making processes in various addictive disorders. We therefore hypothesize that rTMS could lead to a decrease in alcohol consumption in patients with AUD.

Methods/design

We report the protocol of a randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy of rTMS on alcohol reduction in individuals diagnosed with AUD. The study will be conducted in 2 centers in France. Altogether, 144 subjects older than 18 years and diagnosed with AUD will be randomized to receive 5 consecutive twice-daily sessions of either active or sham rTMS (10 Hz over the right DLPFC, 2000 pulses per day). The main outcomes of the study will be changes in alcohol consumption within the 4 weeks after the rTMS sessions. Secondary outcome measures will include changes in alcohol consumption within the 24 weeks, alcohol cravings, clinical and biological improvements, effects on mood and quality of life, and cognitive and safety assessments, and, for smokers, an assessment of the effects of rTMS on tobacco consumption.

Discussion

Several studies have observed a beneficial effect of rTMS on substance use disorders by reducing craving, impulsivity, and risk-taking behavior and suggest that rTMS may be a promising treatment in addiction. However, to date, no studies have included sufficiently large samples and sufficient follow-up to confirm this hypothesis. The results from this large randomized controlled trial will give a better overview of the therapeutic potential of rTMS in AUD.

Trial registration

ClinicalTrials.gov NCT04773691. Registered on 26 February 2021

https://clinicaltrials.gov/ct2/show/NCT04773691?term=trojak&draw=2&rank=5.

Details

Title
Efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing consumption in patients with alcohol use disorders (ALCOSTIM): study protocol for a randomized controlled trial
Author
Petit, Benjamin 1   VIAFID ORCID Logo  ; Soudry-Faure, Agnès 2 ; Jeanjean, Ludovic 3 ; Foucher, Jack 3 ; Lalanne, Laurence 4 ; Carpentier, Maud 5 ; Jonval, Lysiane 2 ; Allard, Coralie 6 ; Ravier, Mathilde 7 ; Mohamed, Amine Ben 5 ; Meille, Vincent 7 ; Trojak, Benoit 8 

1  University Hospital of Dijon, Department of Addictology, Dijon Cedex, France (GRID:grid.31151.37); Université de Bourgogne, UFR des Sciences de Santé, Dijon, France (GRID:grid.5613.1) (ISNI:0000 0001 2298 9313) 
2  University Hospital of Dijon, Unité de Soutien Méthodologique à la Recherche, Délégation à la Recherche et à l’Innovation (DRCI), Dijon Cedex, France (GRID:grid.31151.37) 
3  UMR CNRS 7357 iCube, FMTS (Fédération de Médecine Translationnelle de Strasbourg), Université de Strasbourg, Strasbourg, France (GRID:grid.11843.3f) (ISNI:0000 0001 2157 9291); Centre de neuroModulation Non-Invasive de Strasbourg – CEMNIS, Hôpitaux Universitaires de Strasbourg, Hôpital Civil, Strasbourg Cedex, France (GRID:grid.413866.e) (ISNI:0000 0000 8928 6711) 
4  INSERM 1114, Department of Psychiatry and Addictology, University Hospital of Strasbourg, Fédération de Médecine Translationnelle de Strasbourg (FMTS), Strasbourg, France (GRID:grid.11843.3f) (ISNI:0000 0001 2157 9291); University Hospital of Strasbourg, Fédération de Médecine Translationnelle de Strasbourg (FMTS), Department of Psychiatry and Addictology, Strasbourg, France (GRID:grid.412220.7) (ISNI:0000 0001 2177 138X); Hôpitaux Universitaires de Strasbourg, Pôle Psychiatrie, Santé Mentale et Addictologie, Clinique de psychiatrie, Strasbourg Cedex, France (GRID:grid.412220.7) (ISNI:0000 0001 2177 138X) 
5  University Hospital of Dijon, Délégation à la Recherche et à l’Innovation (DRCI), Dijon Cedex, France (GRID:grid.31151.37) 
6  University Hospital of Dijon, Department of Addictology, Dijon Cedex, France (GRID:grid.31151.37); University Hospital of Dijon, Délégation à la Recherche et à l’Innovation (DRCI), Dijon Cedex, France (GRID:grid.31151.37) 
7  University Hospital of Dijon, Department of Addictology, Dijon Cedex, France (GRID:grid.31151.37) 
8  University Hospital of Dijon, Department of Addictology, Dijon Cedex, France (GRID:grid.31151.37); Université de Bourgogne, UFR des Sciences de Santé, Dijon, France (GRID:grid.5613.1) (ISNI:0000 0001 2298 9313); INSERM UMR1093-CAPS, Université Bourgogne Franche-Comté, UFR des Sciences du Sport, Dijon, France (GRID:grid.493090.7) (ISNI:0000 0004 4910 6615) 
Pages
33
Publication year
2022
Publication date
Dec 2022
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-021-05940-z
ProQuest document ID
2730344724
Copyright
© The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.