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.

Durazzo TC, Kraybill EP, Stephens LH, McCalley DM, Humphreys K, May AC, Padula CB. 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. Drug and Alcohol Dependence. 2025 May 1; 270:112641, DOI: 10.1016/j.drugalcdep.2025.112641.

Related HSR&D Project(s)

• RCS 04-141 – Evaluating Treatment & Self-help Methods of Improving Functioning & Quality of Life Outcomes of Patients with Substance Abuse Disorders

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Abstract:

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 Five participants were withdrawn unrelated to iTBS procedure adverse events.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.