Using brain stimulation to help people quit smoking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.