Using brain stimulation to help veterans quit smoking
Neuroimaging Correlates and Feasibility of Transcranial Magnetic Stimulation (TMS) to Improve Smoking Cessation Outcomes in Veterans With Comorbid PTSD
This study is testing a new way to help veterans with PTSD quit smoking by combining counseling, nicotine replacement, and brain stimulation to see if it works better for them.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05723588 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are US veterans aged 18 to 75 who have a diagnosis of tobacco use disorder and PTSD.
Not a fit: Patients with a history of substance use disorders other than tobacco in the past three months or those with contraindications to TMS or MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for veterans struggling with smoking cessation and PTSD.
How similar studies have performed: While most studies on rTMS for smoking cessation have focused on civilian populations, this study represents a novel approach by specifically targeting veterans with PTSD.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.