Using brain stimulation to help people quit smoking
RTMS Manipulates Imbalanced Drive-reward and Executive Control Circuitry for Smoking Cessation
This study is testing if a special brain treatment can help people quit smoking by focusing on specific areas of the brain that are linked to tobacco addiction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 22 Years to 70 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 2 sites (Charleston, South Carolina and 1 other locations) |
| Trial ID | NCT04903028 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of repetitive transcranial magnetic stimulation (rTMS) to aid smoking cessation by targeting specific neural circuits associated with tobacco use disorder. Participants will undergo brain MRI to personalize their rTMS treatment, which will be administered over 20 sessions in a 4-week period. The study aims to compare the effects of active rTMS on the left dorsolateral prefrontal cortex against a sham treatment in a randomized, double-blinded, sham-controlled design. The goal is to refine treatment parameters and enhance the quit rates among smokers seeking to quit.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 to 70 who smoke at least 10 cigarettes per day and are motivated to quit.
Not a fit: Patients with current substance use disorders or contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, non-pharmacological option for individuals struggling with smoking cessation.
How similar studies have performed: Previous studies have shown that rTMS can reduce cue craving and increase smoking quit rates, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charleston, South Carolina and 1 other locations
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Xingbao Li, MD, MSCR, MS — Medical University of South Carolina
- Study coordinator: Xingbao Li, MD, MSCR, MS
- Email: lixi@musc.edu
- Phone: 843-792-5729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.