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Publications

Journal Article Ahead of print

PubMed: 42091052 DOI: 10.1111/add.70461

Efficacy and safety of transcranial direct current stimulation in alcohol use disorder: A randomized controlled triple-blind trial.

Addiction

Authors: Benoit Trojak, Anne Sauvaget, Wissam El Hage, Thomas Wallenhorst, Benjamin Rolland, Philippe Nubukpo, Ghina Harika-Germaneau, David Szekely, Julie Giustiniani, Marc Auriacombe, Georges Brousse, Sébastien Guillaume, Maxime Bubrovszky, Benjamin Petit, Clémence Cabelguen, Hussein El Ayoubi, Suzanne Rankin, Agnès Soudry-Faure, Karine Goueslard, Anastasia Demina

Affiliations

  • Service Hospitalo-Universitaire d'Addictologie, Université Bourgogne Europe, CHU Dijon Bourgogne, Dijon, France.
  • INSERM U1093, UFR STAPS, Université Bourgogne Europe, Dijon, France.
  • Mouvement, Interactions, Performance, MIP, UR 4334, Nantes Université, CHU Nantes, Nantes, France.
  • CHRU de Tours, Clinique Psychiatrique Universitaire, Tours, France.
  • UMR 1253, iBrain, Université de Tours, INSERM, Tours, France.
  • Service de Psychiatrie Adultes et Addictologie, CH Semur-en-Auxois, Semur-en-Auxois, France.
  • Service Universitaire d'Addictologie de Lyon (SUAL), Hospices Civils de Lyon, CH Le Vinatier, Lyon France unité PSR2, CRNL, UMR 5292 CNRS/1028 INSERM - Université Lyon 1, Bron, France.
  • Inserm U1094, IRD UMR270, Université de Limoges, CHU Limoges, EpiMaCT, Limoges, France.
  • Pôle universitaire de de psychiatrie adultes et addictologie (PUP3A), Centre Hospitalier Esquirol, Limoges, France.
  • CeRCA, CNRS, Université de Poitiers, Université de Tours, Poitiers, France.
  • Unité de Recherche Clinique Pierre Deniker du Centre Hospitalier Henri Laborit, Poitiers, France.
  • Service de Psychiatrie, Centre Hospitalier Princesse Grace, Monaco.
  • UMR INSERM 1322 LINC, Université de Franche Comté, Besançon, France.
  • SANPSY, CNRS UMR 6033, Université de Bordeaux, Bordeaux, France.
  • Pôle Inter-Établissement d'Addictologie, CHU Bordeaux et CH Charles Perrens, Bordeaux, France.
  • Service de Psychiatrie Adulte et d'Addictologie, CHU Clermont-Ferrand CNRS, Université Clermont-Auvergne, Institut Pascal, Clermont-Ferrand, France.
  • Service Urgence et Post-Urgence Psychiatrique, Hôpital Lapeyronie, CHRU, Montpellier, France.
  • Fédération Régionale de Recherche en Santé Mentale et Psychiatrie, Hauts-de-France, France.
  • Etablissement Public de Santé Mentale de l'Agglomération Lilloise, St André-lez-Lille, France.
  • Addiction Medicine and Psychiatry Department, Nantes Université, CHU Nantes, Nantes, France.
  • Direction de la Recherche Clinique et de l'Innovation, Unité de Soutien Méthodologique à la Recherche, CHU Dijon Bourgogne, Dijon, France.

Abstract

BACKGROUND AND AIMS

Current treatment options for alcohol use disorder are limited. Transcranial direct current stimulation has been proposed as a therapeutic approach, but evidence remains scarce. This study aimed to compare active vs. sham transcranial direct current stimulation to evaluate its efficacy and safety in reducing alcohol consumption in a large sample of individuals with alcohol use disorder.

DESIGN

REDSTIM is a triple-blind, randomized, sham-controlled trial that was conducted from October 2015 to January 2022. Participants were followed up every 4 weeks for 24 weeks.

SETTING

Fourteen sites in France and Monaco.

PARTICIPANTS

356 adult outpatients with alcohol use disorder were assessed for eligibility, and 337 were enrolled and randomly assigned (1:1) to receive active or sham stimulation. At baseline, the randomized participants were primarily male (60.5%) with an average age of 51.3 ± 11.3 years.

INTERVENTION AND COMPARATOR

Two daily stimulation sessions (anode F4, cathode F3, 2 mA) delivered over five consecutive days vs. sham stimulation. Direct currents were applied via a pair of 0.9% NaCl-soaked surface sponge electrodes (25 cm 2). In the sham stimulation group, the initial ramp-up time of 15 s (also up to 2 mA) was immediately followed by a ramp down phase of 30 seconds.

MEASUREMENTS

The co-primary outcomes were the change in the number of heavy drinking days (HDD) and total alcohol consumption (TAC) over the follow-up period. Exploratory secondary outcomes included alcohol craving, clinical and biological improvements, quality-of-life, mood, cognitive and safety assessments.

FINDINGS

Over 24 weeks of follow-up, vs. sham, the active stimulation group reported statistically significant reductions in the number of HDD [-2.45 HDD/4 weeks, 97.5% confidence interval (CI) = -4.86 to -0.05, P = 0.022]. The reduction in TAC was not statistically significant (-5.96 g/day, 97.5% CI = -15.18 to 3.26, P = 0.147). The interpretation of these findings should take into account the proportion of missing data related to alcohol diary completeness and losses to follow-up. For secondary outcomes at 24 weeks, vs. sham, craving assessments were lower in the stimulation group (-0.36 95% CI = -0.65 to -0.07, P = 0.016), as were carbohydrate deficient transferrin levels (-0.33 95% CI = -0.65 to -0.01, P = 0.045). In the active vs. sham stimulation group, 69 (41.1%) and 62 participants (36.7%) experienced one or more adverse effects, resulting in 6 dropouts.

CONCLUSIONS

Among adult outpatients with alcohol use disorder, active transcranial direct current stimulation resulted in a modest but sustained reduction in heavy drinking days over 24 weeks, while no statistically significant effect was observed for total alcohol consumption. The intervention was well tolerated.

MeSH

Transcranial Direct Current Stimulation, Safety, Alcoholism, Craving, Therapeutics, Tobacco Use Disorder, Outpatients, Drinking, Alcohol Drinking