Neuroimaging Correlates and Feasibility of Transcranial Magnetic Stimulation (TMS) to Improve Smoking Cessation Outcomes in Veterans With Comorbid PTSD
TMS-STOP
3 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2023
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedStudy Start
First participant enrolled
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
February 18, 2026
February 1, 2026
4 years
February 1, 2023
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Feasibility as measured by number of participants recruited
Number of participants recruited will serve as a measure of study feasibility. Target enrollment is 50 participants.
At consent
Feasibility as measured by the percent of participants who complete the study
The percent of participants who complete the 3-month follow-up visit will serve as a measure of treatment feasibility. 80% retention will be the cut point.
3-month follow-up
Number of participants with self-reported and bioverified abstinence from smoking
Effectiveness of the intervention will be measured by the number of participants who self-report 7-day point prevalence at the end of treatment, and self-report is bioverified by exhaled carbon monoxide.
End of treatment, about five weeks after beginning study
Number of participants with self-reported and bioverified abstinence from smoking
Effectiveness of the intervention will be measured by the number of participants who self-report 7-day point prevalence at the 3-month follow-up visit, and self-report is bioverified by salivary cotinine.
3-month follow-up
Secondary Outcomes (14)
Average number of cigarettes smoked per day in past week
End of treatment, about five weeks after beginning study
Average number of cigarettes smoked per day in past week
3-month follow-up
Self-reported withdrawal symptoms
End of treatment, about five weeks after beginning study
Self-reported withdrawal symptoms
3-month follow-up
Self-report of craving based on Questionnaire of Smoking Urges
End of treatment, about five weeks after beginning study
- +9 more secondary outcomes
Other Outcomes (6)
Self-report posttraumatic stress disorder (PTSD) symptoms
End of treatment, about five weeks after beginning study
Self-report posttraumatic stress disorder (PTSD) symptoms
3-month follow-up
Self-reported depressive symptoms
End of treatment, about five weeks after beginning study
- +3 more other outcomes
Study Arms (2)
active rTMS
EXPERIMENTALParticipants assigned to this group will receive active repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment.
sham rTMS
SHAM COMPARATORParticipants assigned to this group will receive sham repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment.
Interventions
Active rTMS is a non-invasive brain stimulation intervention that is FDA cleared as a treatment for smoking cessation in adults.
Sham rTMS involves no brain stimulation, but appears to the participant and provider to be active rTMS.
All participants will receive five sessions of cognitive behavioral therapy (CBT) for smoking cessation.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan R Young, MD
Durham VA Medical Center, Durham, NC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Participants will receive either active repetitive transcranial magnetic stimulation (rTMS) or sham rTMS. Participants and the PI, who provides the rTMS will be blinded to this condition.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2023
First Posted
February 10, 2023
Study Start
October 31, 2023
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share