Tobacco use is the number one preventable cause of the death in the United States, and is high among US Veterans, and those who have experienced trauma are more likely to smoke. Despite the efficacy of current evidence-based treatments for smoking cessation, there is a critical need for alternative treatments. This project seeks to evaluate the feasibility and effectiveness of a smoking cessation treatment for Veterans with posttraumatic stress disorder (PTSD) who smoke. The treatment combines smoking cessation counseling, nicotine replacement therapy (e.g., nicotine gum), and repetitive transcranial magnetic stimulation (rTMS). rTMS is a noninvasive brain stimulation treatment that has been cleared by the Food and Drug Administration for smoking cessation in adults.
Tobacco use remains the number one preventable cause of death in the United States. Unfortunately, individuals with mental health conditions are disproportionately affected. Tobacco use is also high among US Veterans, and those who have experienced trauma are even more likely to smoke. Successful quitting is especially difficult for individuals who develop posttraumatic stress disorder (PTSD). Despite the efficacy of current evidence-based pharmacotherapies and psychotherapies for smoking cessation, alternative treatments are critically needed. Neuroimaging techniques such as resting-state functional magnetic resonance imaging (rs-fMRI) have provided insight into the neurocircuitry of tobacco use disorder (TUD) and successful quit attempts. Interventions that modulate the neural systems underlying TUD, such as repetitive transcranial magnetic stimulation (rTMS), may be critical to improving clinical outcomes. Indeed, the US Food and Drug Administration (FDA) recently cleared a form of rTMS as a short-term smoking cessation treatment in adults. However, most clinical trials on rTMS for smoking cessation have been conducted in civilian samples and have excluded individuals with psychiatric conditions. To improve smoking cessation treatment options for Veterans with PTSD, it is critical to evaluate novel brain stimulation methods such as rTMS in this vulnerable population. Furthermore, the development of neuroscience-informed techniques to enhance rTMS such as neuronavigation based on rs-fMRI is critical to individualizing rTMS for smoking cessation and understanding mechanisms of action. The application of neuroimaging to develop personalized rTMS targets to precisely modulate targeted underlying neurocircuitry has been successfully applied to the treatment of major depressive disorder (MDD). Similar methodology has been demonstrated successfully for smoking cessation by the candidate's mentors, but this work was completed in a sample of civilian participants making a quit attempt who did not have psychiatric illness. To fill these knowledge gaps, the proposed research aims to develop feasibility data for the therapeutic application individualized neuronavigated rTMS for Veterans with PTSD attempting to quit smoking. Using a feasibility randomized controlled trial (RCT) design, eligible Veterans with PTSD (n=50) seeking smoking cessation will receive rs-fMRI before and after a 5-day course of neuronavigated rTMS the week prior to their quit date, in conjunction with nicotine replacement therapy (NRT) and cognitive behavioral therapy (CBT). The scientific aims of the study are to evaluate feasibility of treatment delivery procedures, develop preliminary effect size estimates, and demonstrate target engagement of the intervention within neural networks critical to TUD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Active rTMS is a non-invasive brain stimulation intervention that is FDA cleared as a treatment for smoking cessation in adults.
Sham rTMS involves no brain stimulation, but appears to the participant and provider to be active rTMS.
All participants will receive five sessions of cognitive behavioral therapy (CBT) for smoking cessation.
All participants will receive nicotine replacement therapy in for the form of 21 mg, 14 mg, and/or 7 mg nicotine patches (based on smoking quantity) and a "rescue" method such as nicotine lozenge or nicotine gum.
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States
RECRUITINGFeasibility as measured by number of participants recruited
Number of participants recruited will serve as a measure of study feasibility. Target enrollment is 50 participants.
Time frame: At consent
Feasibility as measured by the percent of participants who complete the study
The percent of participants who complete the 3-month follow-up visit will serve as a measure of treatment feasibility. 80% retention will be the cut point.
Time frame: 3-month follow-up
Number of participants with self-reported and bioverified abstinence from smoking
Effectiveness of the intervention will be measured by the number of participants who self-report 7-day point prevalence at the end of treatment, and self-report is bioverified by exhaled carbon monoxide.
Time frame: End of treatment, about five weeks after beginning study
Number of participants with self-reported and bioverified abstinence from smoking
Effectiveness of the intervention will be measured by the number of participants who self-report 7-day point prevalence at the 3-month follow-up visit, and self-report is bioverified by salivary cotinine.
Time frame: 3-month follow-up
Average number of cigarettes smoked per day in past week
Participants will self-report the number of cigarettes they have smoked per day in the past week.
Time frame: End of treatment, about five weeks after beginning study
Average number of cigarettes smoked per day in past week
Participants will self-report the number of cigarettes they have smoked per day in the past week.
Time frame: 3-month follow-up
Self-reported withdrawal symptoms
Participants will self-report withdrawal symptoms on the Minnesota Nicotine Withdrawal Scale. Scores on this scale range from 0 to 36, with higher scores indicating higher severity of withdrawal symptoms.
Time frame: End of treatment, about five weeks after beginning study
Self-reported withdrawal symptoms
Participants will self-report withdrawal symptoms on the Minnesota Nicotine Withdrawal Scale. Scores on this scale range from 0 to 36, with higher scores indicating higher severity of withdrawal symptoms.
Time frame: 3-month follow-up
Self-report of craving based on Questionnaire of Smoking Urges
Participants will self-report cravings for tobacco on the Questionnaire of Smoking Urges. Scores on this scale range from 0 to 60, with higher scores indicating higher smoking craving.
Time frame: End of treatment, about five weeks after beginning study
Self-report of craving based on Questionnaire of Smoking Urges
Participants will self-report cravings for tobacco on the Questionnaire of Smoking Urges. Scores on this scale range from 0 to 60, with higher scores indicating higher smoking craving.
Time frame: 3-month follow-up
Number of participants who report relapse to smoking
Measured by self-report, smoking relapse is defined as smoking 5 or more cigarettes per day for 3 consecutive days.
Time frame: End of treatment, about five weeks after beginning study
Number of participants who report relapse to smoking
Measured by self-report, smoking relapse is defined as smoking 5 or more cigarettes per day for 3 consecutive days.
Time frame: 3-month follow-up
Functional network connectivity changes
Comparison of functional network connectivity (FNC) changes between the postcentral gyrus cortical rTMS target and right posterior insula using magnetic resonance imaging before and after the rTMS course
Time frame: End of repetitive transcranial magnetic stimulation treatment, about three weeks after beginning study
Neuroimaging correlates to tobacco use
Correlation of resting state functional connectivity changes pre- vs post-rTMS course and the change in the number of cigarettes smoked in the past 24 hours
Time frame: End of repetitive transcranial magnetic stimulation treatment, about three weeks after beginning study
Self-report of craving based on Urge to Smoke Scale
Participants will report smoking craving using this single-item measure. Scores range from 0 to 100 with higher scores indicating higher smoking craving.
Time frame: End of treatment visit, about five weeks after beginning study
Self-report of craving based on Urge to Smoke Scale
Participants will report smoking craving using this single-item measure. Scores range from 0 to 100 with higher scores indicating higher smoking craving.
Time frame: 3-month follow-up
Self-report of craving based on Urge to Smoke Scale
Participants will self-report craving on the single-item Urge to Smoke Scale. Scores on this scale range from 0 to 100, with higher scores indicating higher cravings to smoke.
Time frame: End of treatment, about five weeks after beginning study
Self-report of craving based on Urge to Smoke Scale
Participants will self-report craving on the single-item Urge to Smoke Scale. Scores on this scale range from 0 to 100, with higher scores indicating higher cravings to smoke.
Time frame: 3-month follow-up
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