RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-31
Study Completion:2027-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05723588

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is a US Veteran
  2. * Meets DSM-5 criteria for tobacco use disorder
  3. * Is between the ages of 18 and 75
  4. * Smokes an average of 10 cigarettes per day for the past 6 months, with carbon monoxide (CO) level \> 6 ppm
  5. * Is willing to attempt smoking cessation
  6. * Meets DSM-5 criteria for current PTSD diagnosis
  7. * Speaks, reads and writes English
  8. * Is willing to sign a Duke consent for those portions of the study that occur at Duke
  9. * Has been stable on psychotropic medications for at least three months
  1. * Has had a substance use disorder other than tobacco in the preceding 3 months
  2. * Has a history of myocardial infarction in the past 6 months or has another contraindication to NRT
  3. * Has a contraindication to TMS or MRI
  4. * Personal or family history of a seizures or epilepsy
  5. * 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
  6. * Structural brain lesion, or prior brain surgery
  7. * Ferromagnetic metal in head (including shrapnel)
  8. * Implanted devices that may be affected by MRI or TMS (pacemaker, medication pump, cochlear implant, implanted deep brain stimulator)
  9. * Is pregnant (to be determined at Duke)
  10. * Is unable to complete study procedures
  11. * Is currently prescribed bupropion and/or varenicline
  12. * Uses other forms of nicotine such as cigars, pipes, chewing tobacco, or vaping
  13. * Is unable to provide informed consent due to a major neurocognitive disorder or other reason
  14. * Meets criteria for a primary psychotic disorder or current manic episode
  15. * Is currently imprisoned or psychiatrically hospitalized
  16. * Has previously received rTMS

Contacts and Locations

Study Contact

Jonathan R Young, MD
CONTACT
(919) 286-0411
jonathan.young14@va.gov
Angela C Kirby, MS
CONTACT
(919) 286-0411
angela.kirby@va.gov

Principal Investigator

Jonathan R Young, MD
PRINCIPAL_INVESTIGATOR
Durham VA Medical Center, Durham, NC

Study Locations (Sites)

Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jonathan R Young, MD, PRINCIPAL_INVESTIGATOR, Durham VA Medical Center, Durham, NC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-31
Study Completion Date2027-11-01

Study Record Updates

Study Start Date2023-10-31
Study Completion Date2027-11-01

Terms related to this study

Keywords Provided by Researchers

  • Tobacco use cessation
  • Veterans

Additional Relevant MeSH Terms

  • Tobacco Use Disorder