TMS + Counseling + Nicotine Replacement for Smoking Cessation
(TMS-STOP Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must not be currently prescribed bupropion or varenicline. You also need to have been stable on any psychotropic medications for at least three months.
What data supports the effectiveness of this treatment for smoking cessation?
Research shows that repetitive Transcranial Magnetic Stimulation (rTMS), when combined with Nicotine Replacement Therapy (NRT), can significantly reduce tobacco cravings and increase quit rates among smokers. In a large study, smokers receiving active rTMS had higher quit rates compared to those receiving a placebo, suggesting that rTMS can be a helpful tool in smoking cessation.12345
Is the combination of TMS, counseling, and nicotine replacement safe for smoking cessation?
How is the TMS + Counseling + Nicotine Replacement treatment for smoking cessation different from other treatments?
This treatment is unique because it combines repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation technique, with counseling and nicotine replacement therapy. rTMS targets brain areas involved in addiction and craving, potentially enhancing the effectiveness of traditional smoking cessation methods.12345
Research Team
Jonathan R Young, MD
Principal Investigator
Durham VA Medical Center, Durham, NC
Eligibility Criteria
This trial is for US Veterans aged 18-75 who smoke at least 10 cigarettes daily, have PTSD, and are stable on psychotropic meds. They must speak English and be willing to try quitting smoking. Excluded are those with brain lesions, recent substance abuse (other than tobacco), heart attack risks, seizure history, certain implanted devices or metals in the head, pregnancy, inability to consent or complete procedures.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Treatment Neuroimaging
Participants undergo resting-state functional magnetic resonance imaging (rs-fMRI) before the rTMS treatment
Treatment
Participants receive a 5-day course of neuronavigated rTMS in conjunction with nicotine replacement therapy (NRT) and cognitive behavioral therapy (CBT)
Post-Treatment Neuroimaging
Participants undergo post-treatment rs-fMRI to assess changes in functional network connectivity
Follow-up
Participants are monitored for smoking cessation outcomes and safety, including self-reported cravings and withdrawal symptoms
3-Month Follow-up
Participants are assessed for long-term smoking cessation outcomes and retention
Treatment Details
Interventions
- Cognitive Behavioral Therapy for Smoking Cessation
- Nicotine Replacement Therapy
- Repetitive Transcranial Magnetic Stimulation (rTMS)
Cognitive Behavioral Therapy for Smoking Cessation is already approved in United States, European Union for the following indications:
- Smoking cessation
- Smoking cessation
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor