Intermittent theta burst to the left dorsolateral prefrontal cortex promoted decreased alcohol consumption and improved outcomes in those with alcohol use disorder: A randomized, double-blind, placebo-controlled clinical trial.

Background: Over 60 % of individuals with alcohol use disorder (AUD) resume hazardous drinking within 6 months post-treatment, necessitating the development of more efficacious interventions. Accumulating evidence suggests transcranial magnetic stimulation (TMS) is a promising intervention for AUD. This randomized, double-blind, placebo-controlled trial assessed the efficacy of intermittent theta burst (iTBS), a form of TMS, as an adjunct treatment for AUD.

Methods: Forty-nine Veterans with AUD (48 males, 1 female) were recruited from residential AUD and substance use disorder treatment. Participants were randomized to 20 sessions of Active (n = 25) or Sham (n = 24) iTBS (1200 pulses/session), targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 14 days or less. Five participants were withdrawn unrelated to iTBS procedure adverse events. Participant alcohol/substance use was monitored for 6-months following final iTBS session.

Results: Relative to participants who received Sham iTBS, those who received Active iTBS showed a significantly greater reduction in percent heavy drinking days and a trend for higher rate of continuous abstinence over 6-months. Among participants who resumed alcohol consumption, those in the Active group demonstrated significantly lower quantity and duration of alcohol consumption than Sham. Pre-study alcohol consumption variables were not related to post-iTBS treatment outcomes.

Conclusions: Findings indicated that Active left DLPFC iTBS, delivered over approximately 2-weeks, was a safe and efficient intervention for AUD that promoted significantly reduced heavy drinking and improved clinical outcomes compared to Sham over 6-months post-iTBS. This study provides novel data to inform and power future larger-scale, multi-site clinical trials employing iTBS for AUD.