Neuroimaging Correlates and Feasibility of Transcranial Magnetic Stimulation (TMS) to Improve Smoking Cessation Outcomes in Veterans With Comorbid PTSD

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Feb 1, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to help veterans quit smoking, especially those who also face challenges related to posttraumatic stress disorder (PTSD). The study combines traditional smoking cessation support, such as counseling and nicotine replacement therapy (like nicotine gum), with a treatment called repetitive transcranial magnetic stimulation (rTMS). rTMS is a safe, non-invasive procedure that uses magnetic fields to stimulate the brain and has been approved for helping adults quit smoking. The aim is to see if this combination can improve the chances of success in quitting smoking among veterans.

To participate in this trial, individuals need to be U.S. veterans aged 18 to 75 who smoke about 10 cigarettes a day and have a diagnosed tobacco use disorder along with current PTSD. They should be willing to try quitting smoking and have been stable on their medications for at least three months. Participants can expect to receive support in their quit attempt and undergo rTMS sessions, along with regular check-ins. It's important to note that certain health conditions or recent substance use may prevent eligibility, so potential participants would need to discuss their medical history before enrolling.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Is willing to attempt smoking cessation
• • Meets DSM-5 criteria for current PTSD diagnosis
• • Speaks, reads and writes English
• • Is willing to sign a Duke consent for those portions of the study that occur at Duke
• • Has been stable on psychotropic medications for at least three months
• Exclusion Criteria:
• • 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
• • History of neurological condition that increases the risk of seizures including stroke or transient ischemic attack, cerebral aneurysm, or severe traumatic brain injury from a penetrating head injury, loss of consciousness \> 20 minutes at time of traumatic injury, requiring an anticonvulsant medication for seizures, and/or found to have encephalomalacia on baseline MRI
• • Structural brain lesion, or prior brain surgery
• • Ferromagnetic metal in head (including shrapnel)
• • Implanted devices that may be affected by MRI or TMS (pacemaker, medication pump, cochlear implant, implanted deep brain stimulator)
• • Is pregnant (to be determined at Duke)
• • Is unable to complete study procedures
• • Is currently prescribed bupropion and/or varenicline
• • Uses other forms of nicotine such as cigars, pipes, chewing tobacco, or vaping
• • Is unable to provide informed consent due to a major neurocognitive disorder or other reason
• • Meets criteria for a primary psychotic disorder or current manic episode
• • Is currently imprisoned or psychiatrically hospitalized
• • Has previously received rTMS