Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05723588

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

Led by VA Office of Research and Development · Updated on 2026-02-18

50

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Is a US Veteran
  • Meets DSM-5 criteria for tobacco use disorder
  • Is between the ages of 18 and 75
  • Smokes an average of 10 cigarettes per day for the past 6 months, with carbon monoxide (CO) level > 6 ppm
  • Is willing to attempt smoking cessation
  • Meets DSM-5 criteria for current PTSD diagnosis
  • Speaks, reads and writes English
  • Is willing to sign a Duke consent for those portions of the study that occur at Duke
  • Has been stable on psychotropic medications for at least three months
Not Eligible

You will not qualify if you...

  • Has had a substance use disorder other than tobacco in the preceding 3 months
  • Has a history of myocardial infarction in the past 6 months or has another contraindication to nicotine replacement therapy
  • Has a contraindication to transcranial magnetic stimulation or MRI, including:
    • Personal or family history of seizures or epilepsy
    • History of neurological condition increasing seizure risk such as stroke, transient ischemic attack, cerebral aneurysm, or severe traumatic brain injury
    • Structural brain lesion or prior brain surgery
    • Ferromagnetic metal in head (including shrapnel)
    • Implanted devices affected by MRI or TMS (pacemaker, medication pump, cochlear implant, deep brain stimulator)
    • Is pregnant
  • Is unable to complete study procedures
  • Is currently prescribed bupropion and/or varenicline
  • Uses other forms of nicotine such as cigars, pipes, chewing tobacco, or vaping
  • Is unable to provide informed consent due to a major neurocognitive disorder or other reason
  • Meets criteria for a primary psychotic disorder or current manic episode
  • Is currently imprisoned or psychiatrically hospitalized
  • Has previously received rTMS

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705-3875

Actively Recruiting

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Research Team

J

Jonathan R Young, MD

CONTACT

A

Angela C Kirby, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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