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Taking people in United StatesPhase 2

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

Key facts

Who runs it
VA Office of Research and Development
Where
Durham, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
50 people, planned
Started
31 Oct 2023
Expected to end
1 Nov 2027
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • active repetitive transcranial magnetic stimulation
  • sham repetitive transcranial magnetic stimulation
  • cognitive behavioral therapy for smoking cessation
  • nicotine replacement therapy
Record updated
18 February 2026

Who can take part

Age
18 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Has a contraindication to TMS or MRI; Personal or family history of a seizures or epilepsy; History of neurological condition that increases the risk of seizures including stroke or transient ischemic attack, cerebral aneurysm, or severe traumatic brain injury from a penetrating head injury, loss of consciousness > 20 minutes at time of traumatic injury, requiring an anticonvulsant medication for seizures, and/or found to have encephalomalacia on baseline MRI; Structural brain lesion, or prior brain surgery; Ferromagnetic metal in head (including shrapnel); Implanted devices that may be affected by MRI or TMS (pacemaker, medication pump, cochlear implant, implanted deep brain stimulator); Is pregnant (to be determined at Duke)
  • Has previously received rTMS
  • 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 NRT
  • 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 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 currently imprisoned or psychiatrically hospitalized

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in United States

  • Durham VA Medical Center, Durham, NCDurham, United StatesContact: Susanna B Oberg, AAS AASTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • active rTMSTreatment being tested

    Participants assigned to this group will receive active repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment.

    Treatment: active repetitive transcranial magnetic stimulation, cognitive behavioral therapy for smoking cessation, and nicotine replacement therapy

  • sham rTMSSham treatment, for comparison

    Participants assigned to this group will receive sham repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment.

    Treatment: sham repetitive transcranial magnetic stimulation, cognitive behavioral therapy for smoking cessation, and nicotine replacement therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT05723588, who can take part
Record updated
18 February 2026