Abstract
BackgroundDespite the considerable success of comprehensive tobacco control efforts, tobacco use remains one of the greatest preventable causes of death and disease today. Over half of all smokers in the US make quit attempts every year, but over 90% relapse within 12 months, choosing the immediate reinforcement of smoking over the long-term benefits of quitting. Conceptual and empirical evidence supports continued investigation of high frequency repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex in reducing relapse and decreasing cigarette consumption. While this evidence is compelling, an optimal dosing strategy must be determined before a long-term efficacy trial can be conducted. The goal of this study is to determine a dosing strategy for 20 Hz rTMS that will produce the best long-term abstinence outcomes with the fewest undesirable effects.MethodsThis is a fully crossed, double-blinded, sham-controlled, 3x2x2 randomized factorial study. The three factors are duration (stimulation days: 8, 12, and 16); intensity (900 or 1800 pulses per day); and sham control. Participants (n = 258) will consist of adults (18–65) who are motivated to quit smoking cigarettes and who will be followed for 6 months post-quit. Outcomes include latency to relapse, point prevalence abstinence rates, delay discounting rates, cognitive-behavioral skills acquisition, and multiple measures of potential undesirable effects that impact participant compliance.DiscussionThis study integrates existing theoretical concepts and methodologies from neuropsychology, behavioral economics, brain stimulation, clinical psychology, and the evidence-based treatment of tobacco dependence in the development of a promising and innovative approach to treat tobacco dependence. This study will establish an optimal dosing regimen for efficacy testing. Findings are expected to have a significant influence on advancing this approach as well as informing future research on clinical approaches that combine rTMS with other evidence-based treatments for tobacco dependence and perhaps other addictions.Trial registrationClinical Trials NCT03865472 (retrospectively registered). The first participant was fully enrolled on November 26, 2018. Registration was posted on March 7, 2019.
Highlights
Despite the considerable success of comprehensive tobacco control efforts, tobacco use remains one of the greatest preventable causes of death and disease today
Findings are expected to have a significant influence on advancing this approach as well as informing future research on clinical approaches that combine repetitive transcranial magnetic stimulation (rTMS) with other evidence-based treatments for tobacco dependence and perhaps other addictions
The dorsolateral prefrontal cortex, a functional node in the prefrontal cortex (PFC), has a significant role in self-control in general and the controlled response inhibition associated with managing the desire to smoke, called incentive salience [14,15,16,17,18,19]
Summary
Despite the considerable success of comprehensive tobacco control efforts, tobacco use remains one of the greatest preventable causes of death and disease today. Conceptual and empirical evidence supports continued investigation of high frequency repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex in reducing relapse and decreasing cigarette consumption While this evidence is compelling, an optimal dosing strategy must be determined before a long-term efficacy trial can be conducted. Smoking cessation involves repeatedly choosing between the known, immediate, and reinforcing experience of smoking and a variety of dynamic choice options from which the smoker repeatedly chooses throughout the day in the context of continually fluctuating neurobiological, environmental, and cognitive influences [8,9,10] Executive functions such as self-control are essential to managing the repetitive choice process if one is to attain long-term abstinence [11,12,13]. The absence of nicotine during a quit attempt amplifies executive function neural processing deficits, increases incentive salience, and is likely to contribute to the choice to smoke, even if it means relapse [23, 24]
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