RecruitingPhase 2NCT05723588

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


Sponsor

VA Office of Research and Development

Enrollment

50 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a brain stimulation therapy called repetitive transcranial magnetic stimulation (rTMS) — a non-invasive procedure that uses magnetic pulses to stimulate areas of the brain — can improve smoking cessation rates in US military veterans who have both tobacco use disorder and post-traumatic stress disorder (PTSD). The study also uses brain imaging (MRI) to understand how rTMS works. **You may be eligible if...** - You are a US veteran between 18 and 75 years old - You have PTSD and smoke at least 10 cigarettes per day (for the past 6 months) - You are motivated to try to quit smoking - Your psychiatric medications have been stable for at least 3 months - You can read and write English **You may NOT be eligible if...** - You have a substance use disorder (other than tobacco) in the past 3 months - You have had a heart attack in the past 6 months or a condition that makes nicotine replacement unsafe - You have any condition that makes TMS or MRI unsafe (metal implants in the head, seizure history, pacemaker, cochlear implant, deep brain stimulator, etc.) - You are pregnant - You are currently taking bupropion or varenicline (smoking cessation medications) - You have previously received rTMS treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEactive repetitive transcranial magnetic stimulation

Active rTMS is a non-invasive brain stimulation intervention that is FDA cleared as a treatment for smoking cessation in adults.

DEVICEsham repetitive transcranial magnetic stimulation

Sham rTMS involves no brain stimulation, but appears to the participant and provider to be active rTMS.

BEHAVIORALcognitive behavioral therapy for smoking cessation

All participants will receive five sessions of cognitive behavioral therapy (CBT) for smoking cessation.

DRUGnicotine replacement therapy

All 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.


Locations(1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

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NCT05723588


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