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Recruiting
NCT07050862
Personalized Brain Stimulation to Help Veterans Quit Smoking
Conditions: Tabacco Use Disorder, rTMS
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 56
Sponsor: VA Office of Research and Development
Location: Ralph H. Johnson VA Medical Center, Charleston, SC Charleston South Carolina
Summary
Cigarette smoking is a significant public health concern for Veterans. Encouraging smoking cessation continues to be a top priority for the Veterans' Administration as Veterans who use tobacco experience negative health effects, including cancer, heart disease, and mental disorders. Despite the efficacy of current evidence-based pharmacotherapies and psychotherapies for smoking cessation, alternative treatments are critically needed. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive form of brain stimulation, US FDA-approved for smoking cessation. In this protocol, the investigators propose comparing the two rTMS protocols (standard TMS vs. precision TMS) to find a better treatment parameter for smoking cessation in Veterans. Identifying an efficacious rTMS protocol would benefit Veterans who want to quit smoking.
Eligibility Criteria
Inclusion Criteria:
* Veteran
* Individuals who smoke 10 or more cigarettes per day and have a CO level \> 10 ppm indicative of recent smoking
* Those who have not received substance abuse treatment within the previous 30 days
* Those who have been stable on psychotropic medications for at least three months
* For females, those who test non-pregnant and use adequate birth control
* Those who are willing to provide informed consent
* Those who can comply with protocol requirements and likely complete all study procedures
* Those who are motivated to quit smoking (based on responses of "very likely" or "somewhat likely" in the motivation questionnaire
Exclusion Criteria:
* Current moderate to severe substance use of any psychoactive substances other than nicotine or caffeine, as defined by DSM-V criteria
* Contraindications to MRI (e.g., metal in the skull, orbital or intracranial cavity, or claustrophobia)
* Contraindications to rTMS (history of a seizure or epilepsy)
* A history of autoimmune, endocrine, viral, or vascular disorders affecting the brain
* History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment
* Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea
* Major Axis I disorders diagnosed according to DSM-V criteria, such as bipolar affective disorder, schizophrenia, dementia, or major depression
* Regarding the Veteran population, the investigators will enroll smokers who have PTSD
* Current use of other forms of nicotine delivery, such as nicotine patches or electronic cigarettes
* Currently prescribed bupropion and/or varenicline
Source: ClinicalTrials.gov (NCT07050862). StuddyBuddy aggregates publicly available trial information.