Open AccessRepetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double‐blind randomized controlled trial
Author(s) -
Zangen Abraham,
Moshe Hagar,
Martinez Diana,
BarneaYgael Noam,
Vapnik Tanya,
Bystritsky Alexander,
Duffy Walter,
Toder Doron,
Casuto Leah,
Grosz Moran Lipkinsky,
Nunes Edward V.,
Ward Herbert,
Tendler Aron,
Feifel David,
Morales Oscar,
Roth Yiftach,
Iosifescu Dan V.,
Winston Jaron,
Wirecki Theodore,
Stein Ahava,
Deutsch Frederic,
Li Xingbao,
George Mark S.
Publication year - 2021
Publication title -
world psychiatry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 15.51
H-Index - 93
eISSN - 2051-5545
pISSN - 1723-8617
DOI - 10.1002/wps.20905
Subject(s) - medicine , abstinence , randomized controlled trial , craving , transcranial magnetic stimulation , smoking cessation , nicotine withdrawal , cotinine , clinical trial , psychiatry , anesthesia , addiction , nicotine , stimulation , pathology
Repetitive transcranial magnetic stimulation (rTMS) is a non‐invasive brain stimulation method increasingly used to treat psychiatric disorders, primarily depression. Initial studies suggest that rTMS may help to treat addictions, but evaluation in multicenter randomized controlled trials (RCTs) is needed. We conducted a multicenter double‐blind RCT in 262 chronic smokers meeting DSM‐5 criteria for tobacco use disorder, who had made at least one prior failed attempt to quit, with 68% having made at least three failed attempts. They received three weeks of daily bilateral active or sham rTMS to the lateral prefrontal and insular cortices, followed by once weekly rTMS for three weeks. Each rTMS session was administered following a cue‐induced craving procedure, and participants were monitored for a total of six weeks. Those in abstinence were monitored for additional 12 weeks. The primary outcome measure was the four‐week continuous quit rate (CQR) until Week 18 in the intent‐to‐treat efficacy set, as determined by daily smoking diaries and verified by urine cotinine measures. The trial was registered at ClinicalTrials.gov (NCT02126124). In the intent‐to‐treat analysis set (N=234), the CQR until Week 18 was 19.4% following active and 8.7% following sham rTMS (X 2 =5.655, p=0.017). Among completers (N=169), the CQR until Week 18 was 28.0% and 11.7%, respectively (X 2 =7.219, p=0.007). The reduction in cigarette consumption and craving was significantly greater in the active than the sham group as early as two weeks into treatment. This study establishes a safe treatment protocol that promotes smoking cessation by stimulating relevant brain circuits. It represents the first large multicenter RCT of brain stimulation in addiction medicine, and has led to the first clearance by the US Food and Drug Administration for rTMS as an aid in smoking cessation for adults.