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

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Durham VA Medical Center, Durham, NC
RECRUITING
Durham
Contact Information
Primary
Jonathan R Young, MD
jonathan.young14@va.gov
(919) 286-0411
Backup
Angela C Kirby, MS
angela.kirby@va.gov
(919) 286-0411
Time Frame
Start Date: 2023-10-31
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov