A 6-week program of repetitive transcranial magnetic stimulation (rTMS) was found to significantly reduce craving and cigarette consumption, resulting in a doubling of the quit rate among individuals with tobacco-use disorder, according to a study published in World Psychiatry. The results of this prospective, multicenter, double-blind, randomized controlled trial (ClinicalTrials.gov Identifier: NCT02126124) led to the US Food and Drug Administration providing clearance for rTMS to aid in smoking cessation.
The study cohort included 262 adults 22 to 70 years of age with tobacco-use disorder who smoked at least 10 cigarettes daily for at least 1 year. All study participants were motivated to quit. They had no period of abstinence longer than 3 months in the past year; 68% of patients reported 3 attempts to quit, and 27% reported more than 5 attempts to quit.
Study participants were randomly assigned to a regimen of rTMS targeting the lateral prefrontal cortex and insula (n=123) or sham rTMS (n=139) during cue-induced cravings at a frequency of 5 days per week for 3 weeks followed by 3 weeks of once-weekly rTMS or sham.
At week 6, the continuous quit rate was 25.3% for individuals in the rTMS group and 6.4% for the sham group (x2 =11.885, P =.0006). The researchers completed follow-up assessments at week 18 with those who had quit at week 6 and found that smoking cessation persisted for 63% of the rTMS group and 50% of the sham group (x2 =8.46, P =.003). Of the 169 individuals who completed the study, 28% in the rTMS group and 11.7% of the sham group were abstinent (x2 =7.219, P =.007).
Of those who completed the study, the rTMS group smoked a mean 95.5 fewer cigarettes than the sham group from baseline until week 6. The rTMS group experienced significantly greater mean weekly reduction in total score on the Tobacco Craving Questionnaire compared with the sham treatment group (adjusted mean weekly difference between groups=5.71 P =.028). Treatment with rTMS was linked with reduced craving (F1,253=4.85, P =.028). The rTMS group also had higher odds of quitting (odds ratio: active=1.57, P =.004; sham=0.85, P =.46).
Nearly 25% of individuals in the rTMS group experienced headache (24.4%) compared with 18% of individuals receiving sham treatment. Pain or discomfort at application site, jaw pain, facial pain, muscle pain and/or spasm, twitching, and neck pain were reported to be of mild or moderate severity and resolved after treatment, often after adjustment to treatment. The investigator terminated treatment in 1 patient in the rTMS group who reported a serious adverse event of tinnitus, which resolved. More participants in the rTMS group reported experiencing adverse events compared with patients in the sham treatment group (53.7% vs. 36.0%, x2=8.274, P =.004).
“This study suggests that rTMS directly affects neurocircuitry implicated in craving and might be effective in treating other addictions as well,” the investigators said. “The clinical benefits, including the fast onset and minor side effects, outweigh the minimal risks involved.”
The researchers said rTMS may especially help patients with tobacco-use disorder and a long history of smoking who have unsuccessfully attempted to quit several times, along with patients with other addictions.
Disclosure: This research was supported by Brainsway Ltd. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Zangen A, Moshe H, Martinez D, et al. Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. World Psychiatry. 2021;20(3):397-404. doi:10.1002/wps.20905