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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07050862). StuddyBuddy aggregates publicly available trial information.