Recruiting
Phase 2

TMS

Sponsor:

VA Office of Research and Development

Code:

NCT05723588

Conditions

Tobacco Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

active repetitive transcranial magnetic stimulation

sham repetitive transcranial magnetic stimulation

cognitive behavioral therapy for smoking cessation

nicotine replacement therapy

Study Details

Brief 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.

Conditions

Tobacco Use Disorder

Study ID

NCT05723588

Start date

Oct 31, 2023

Status verified date

Feb, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: active rTMS

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

sham comparator: sham rTMS

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

Interventions

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.

sham repetitive transcranial magnetic stimulation

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

cognitive behavioral therapy for smoking cessation

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

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.

Primary outcome measure

  • Feasibility as measured by number of participants recruited [ Time Frame: At consent ]
  • Feasibility as measured by the percent of participants who complete the study [ Time Frame: 3-month follow-up ]
  • Number of participants with self-reported and bioverified abstinence from smoking [ Time Frame: End of treatment, about five weeks after beginning study ]
  • Number of participants with self-reported and bioverified abstinence from smoking [ Time Frame: 3-month follow-up ]

Central Contacts and Locations

Central contacts

Jonathan R Young, MD

(919) 286-0411jonathan.young14@va.gov

Angela C Kirby, MS

(919) 286-0411angela.kirby@va.gov

Locations

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Susanna B Oberg, AAS AAS

615-873-6955susanna.oberg@va.gov

Principal Investigator:

Jonathan R Young, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • Tobacco use cessation
  • Veterans

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-02-18.