Effects of 10 add-on HF-rTMS treatment sessions on alcohol use and craving among detoxified inpatients with alcohol use disorder: a randomized sham-controlled clinical trial

Background and aims: Alcohol use disorder (AUD) is a chronic disorder with high relapse rates. There are currently few clinical trials of high frequency repetitive transcranial magnetic stimulation (HF-rTMS) to reduce alcohol use among AUD patients, and results are mixed. The current study tested the effect of 10 add-on sessions of HF-rTMS over the right dorsolateral pre-frontal cortex (DLPFC) on alcohol use and craving. Design: Single-center, single blind sham-controlled parallel-group RCT (n = 80), with 3 and 6 months follow-up. Setting: Clinical treatment center in Amsterdam, the Netherlands. Participants: Eighty detoxified and abstinent AUD inpatients in clinical treatment (20 females, average age = 44.35 years). Intervention: Ten sessions of active or sham HF-rTMS (60 10 Hz trains of 5 sec at 110% motor threshold) over the right DLPFC on 10 consecutive work-days. Measurements: The primary outcome measure is the number of abstinent days over 6-month follow-up (FU). Secondary outcome measures are craving over 6-month FU (alcohol urge questionnaire and obsessive-compulsive drinking scale), time to first relapse over 6-month FU and grams of alcohol consumed over 6-month FU. Additional outcome measures: full abstinence over 6-month FU and treatment success over 12-month FU. Findings: HF-rTMS did not affect the number of abstinent days over 6 months FU [sham = 124 ± 65.9 days, active = 115 ± 69.8 days, difference: 9 days, 95% confidence interval (CI) = Poisson model: 0.578–3.547]. Moreover, HF-rTMS did not affect craving (AUQ/OCDS) (sham = 15.38/5.28, active = 17.48/4.75, differences = 2.1/−0.53, 95% CI mixed-effects model = −9.14 to 2.07/−1.44 to 2.40). Conclusions: There was no clear evidence that high-frequency repetitive transcranial magnetic stimulation over the right dorsolateral pre-frontal cortex treatment has a long-term positive effect on alcohol use or craving as add-on treatment for alcohol use disorder. High treatment response at 6-month follow-up could have limited the possibility to find an effect.