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RECRUITING
NCT05723588
PHASE2

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-10-31

Completion Date

2027-11-01

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

DEVICE

active 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.

DEVICE

sham repetitive transcranial magnetic stimulation

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

BEHAVIORAL

cognitive behavioral therapy for smoking cessation

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

DRUG

nicotine 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