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Not Yet Recruiting NCT05723588

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

Conditions: Tobacco Use Disorder

Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE2
Enrollment: 50
Sponsor: VA Office of Research and Development

Location: United States

Summary

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.

Eligibility Criteria

Inclusion Criteria:Is a US VeteranMeets DSM-5 criteria for tobacco use disorderIs between the ages of 18 and 75Smokes an average of 10 cigarettes per day for the past 6 months, with carbon monoxide (CO) level > 6 ppmIs willing to attempt smoking cessationMeets DSM-5 criteria for current PTSD diagnosisSpeaks, reads and writes EnglishIs willing to sign a Duke consent for those portions of the study that occur at DukeHas been stable on psychotropic medications for at least three monthsExclusion Criteria:Has had a substance use disorder other than tobacco in the preceding 3 monthsHas a history of myocardial infarction in the past 6 months or has another contraindication to NRTHas a contraindication to TMS or MRIPersonal or family history of a seizures or epilepsyHistory 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 MRIStructural brain lesion, or prior brain surgeryFerromagnetic 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 proceduresIs currently prescribed bupropion and/or vareniclineUses other forms of nicotine such as cigars, pipes, chewing tobacco, or vapingIs unable to provide informed consent due to a major neurocognitive disorder or other reasonMeets criteria for a primary psychotic disorder or current manic episodeIs currently imprisoned or psychiatrically hospitalizedHas previously received rTMS

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05723588). StuddyBuddy aggregates publicly available trial information.