Using brain stimulation to help veterans quit smoking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility and effectiveness of a smoking cessation treatment specifically designed for veterans with posttraumatic stress disorder (PTSD) who smoke. The intervention combines smoking cessation counseling, nicotine replacement therapy, and repetitive transcranial magnetic stimulation (rTMS), a noninvasive brain stimulation technique. By utilizing neuroimaging techniques, the study aims to understand the neurocircuitry involved in tobacco use disorder and improve treatment outcomes for this vulnerable population. The study is conducted at the Durham VA Medical Center and targets veterans aged 18 to 75 who meet specific criteria for tobacco use disorder and PTSD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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)
* 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

Where it's running

• Durham VA Medical Center, Durham, NC
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Jonathan R Young, MD — Durham VA Medical Center, Durham, NC
• Study coordinator: Jonathan R Young, MD
• Email: jonathan.young14@va.gov
• Phone: (919) 286-0411

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Facilitating Tobacco Treatment in Veterans with Serious Mental Illness

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.