NCT04903028 · Medical University of South Carolina
RTMS Targets Neural Circuits for Smoking Cessation
What this study is about
Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers. In this study, investigators will use brain MRI to guide TMS therapy for smoking cessation.
View original scientific description
Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers. In this study, investigators will use brain MRI to guide TMS therapy for smoking cessation.
Interventions
DEVICE
Sham rTMS
Two electrodes on the scalp will be connected to transcutaneous electrical nerve stimulation.
DEVICE
Active rTMS 10 Hz DLPFC
10 Hz repetitive transcranial magnetic stimulation (rTMS) will be delivered over left dorsolateral prefrontal cortex (DLPFC).
Primary outcome measures
4 week continue quit rate
Time frame: 20 weeks
Measured by self-report of smoking abstinence in the past 4 weeks and confirmed using urine cotinine measurement.
Task-functional connectivity from functional magnetic resonance imaging (fMRI)
Time frame: 4 week
The strength of functional connectivity is used to present the brain activities. The fMRI scans will be measured before the first TMS, after 2 weeks TMS and after the last TMS treatment.
Cigarette per day
Time frame: 20 weeks
Cigarette per day (CPD) is measured to index smoking reduction and cigarette consumption.
Adverse Event
Time frame: 4 weeks
Participants will be asked about adverse events (AE) each visit during treatment. AEs will be measured each TMS treatment visit.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Be between the ages of 22 and 70 years old.
- Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level \> 10 ppm indicative of recent smoking.
- Have not received substance abuse treatment within the previous 30 days.
- Meet the criteria for tobacco use disorder as determined by DSM-5.
- Be in stable mental and physical health.
- If female, test non-pregnant and use adequate birth control.
- Show no evidence of focal or diffuse brain lesions on MRI.
- Be willing to provide informed consent.
- Be able to comply with protocol requirements and likely to complete all study procedures.
- Be motivated to quit smoking (based on responses of "very likely," or "somewhat likely" in the motivation questionnaire).
Exclusion criteria
- Current moderate to severe substance use of any psychoactive substances other than nicotine or caffeine, as defined by DSM-V criteria.
- Contraindications to MRI (e.g., presence of metal in the skull, orbital or intracranial cavity, or having claustrophobia).
- Contraindication to rTMS.
- History of autoimmune, endocrine, viral, or vascular disorders affecting the brain.
- History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
- Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea.
- Lifetime history of major Axis I disorders such as: bipolar affective disorder (BPAD), schizophrenia, post-traumatic stress disorder (PTSD), dementia, suicidal ideation or major depression.
- Self-report of \>21 standard alcohol drinks per week in any week in the 30 days prior to screening.
- Use of other forms of nicotine delivery, such as nicotine patches, electronic cigarettes, gum, nasal spray, inhalers, and nicotine lozenges.
- Use of other tobacco products, including cigars, cigarillos, chew, snuff, and pouches/snus.
- Previous treatment with TMS.
Where
- Charleston, South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations