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.
Is a US Veteran
Meets DSM-5 criteria for tobacco use disorder
Is between the ages of 18 and 75
Smokes an average of 10 cigarettes per day for the past 6 months, with carbon monoxide (CO) level > 6 ppm
Has had a substance use disorder other than tobacco in the preceding 3 months
Has a history of myocardial infarction in the past 6 months or has another contraindication to NRT
Has a contraindication to TMS or MRI
Personal or family history of a seizures or epilepsy
Parallel
active repetitive transcranial magnetic stimulation
DeviceActive rTMS is a non-invasive brain stimulation intervention that is FDA cleared as a treatment for smoking cessation in adults.
sham repetitive transcranial magnetic stimulation
DeviceSham rTMS involves no brain stimulation, but appears to the participant and provider to be active rTMS.
cognitive behavioral therapy for smoking cessation
BehavioralAll participants will receive five sessions of cognitive behavioral therapy (CBT) for smoking cessation.
nicotine replacement therapy
DrugAll 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.
Feasibility as measured by number of participants recruited
Number of participants recruited will serve as a measure of study feasibility. Target enrollment is 50 participants.
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.
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.
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.
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.
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.
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.
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.
Self-report posttraumatic stress disorder (PTSD) symptoms
Participants will self-report PTSD symptoms on the PTSD Checklist - 5. Scores on this measure range from 0 to 80, with higher scores indicating higher severity of PTSD symptoms.
Self-report posttraumatic stress disorder (PTSD) symptoms
Participants will self-report PTSD symptoms on the PTSD Checklist - 5. Scores on this measure range from 0 to 80, with higher scores indicating higher severity of PTSD symptoms.
Self-reported depressive symptoms
Participants will self-report depression symptoms on the Inventory of Depressive Symptomatology. Scores on this scale range from 0 to 90, with higher scores indicating higher depression symptom severity.
Self-reported depressive symptoms
Participants will self-report depression symptoms on the Beck Depression Inventory - 2. Scores on this scale range from 0 to 63, with higher scores indicating higher depression symptom severity.
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