Cigarette smoking constitutes the greatest preventable cause of mortality and morbidity in the US. The most critical period for long term success of smoking cessation appears to be in the first 7 days after the quit date. A metaanalysis of 3 pharmacotherapy trials revealed that abstinence during the first 7 days was the strongest predictor of 6 month outcomes (n=1649; Odds ratio: 1.4, P \<0.0001; Ashare et al. 2013). Prodigious relapse rates during this first week of smoking cessation are likely due to behavioral and neurobiological factors that contribute to high cue-associated craving and low executive control over smoking. The long term goal of the research is to develop evidence-based transcranial magnetic stimulation protocols to facilitate abstinence during this critical period.
The investigators will evaluate the efficacy of TMS to the ventromedial prefrontal cortex (vmPFC) to change smoking-related behaviors. The investigators long-term vision is that TBS would be used as an acute intervention enabling individuals to get through the first week after a smoking quit attempt without relapsing, and transition to more sustainable mechanisms of behavioral change (e.g., medication, cognitive behavioral therapy). Aim 1 (Strategy 1): Modulating the limbic system as an approach to treatment: vmPFC TBS. Cigarette smokers will be randomized to receive 10 days of real TBS or sham TBS directed to the vmPFC. Intermittently the desire to smoke, and cigarette self-administration will be assessed. The investigators hypothesize that TBS will: 1) decrease the behavioral smoking measures described above, which will be sustained over a time period sufficient to overcome the initial quit attempt (\~7-14 days). The outcomes of the present aims will resolve a critical gap in the investigator's knowledge regarding the efficacy of a promising TMS treatment strategies. These outcomes will be directly translated to a larger longitudinal study evaluating a multi-pronged approach to improving outcomes in traditional pharmacotherapy or behavioral treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
This will be delivered with the Magventure Magpro system; active sham coil (double blinded)
The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil.
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Questionnaire on Smoking Urges Administered Daily Pre TMS to Measure Craving
Questionnaire on Smoking Urges (QSU). This 10-item questionnaire assesses cigarette craving. Participants will be asked to rate from 1 (strongly disagree) to 7 (strongly agree) their agreement with several statements (e.g., "I have a desire for a cigarette right now," and "Nothing would be better than smoking a cigarette right now."). Individual scores can range from 7 to 49. Higher scores represent more craving. QSU scores are averaged per individual per time point. Scores for all time points and all participants were averaged for each arm (real vs sham TMS).
Time frame: Through study completion, an average of 8 weeks
Self- Report Assessment of Cigarette Use Through Timeline Follow-Back (TLFB) Interview
This self-reported tobacco product use interview asks participants to retrospectively estimate the number of cigarettes they've used each day for the past 30 days or since the previous assessment, whichever is fewer.
Time frame: Through study completion, an average of 8 weeks
Biochemical Assessment of Tobacco Use Via Quantitative Urine Screens to Detect Cotinine Level
Changes in cigarette use as detected by quantitative cotinine urine screens collected at visits 1, 6, 10, and all follow-ups. Values are averaged across all time points.
Time frame: Through study completion, an average of 8 weeks
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