Personalized brain-targeted TMS for smoking cessation

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

Adults with tobacco use disorder undergo MRI to map brain connections and are randomized to receive either PRIME TMS, which targets the stimulation to the participant’s own reward-connected brain region, or a standard landmark-based TMS. Each participant receives 15 sessions over about three weeks, with the PRIME group also completing a short reward-based task during stimulation to potentially boost effects. The study measures changes in reward-related brain activity and smoking behavior to determine which approach is more effective. The trial is conducted at Rutgers with collaboration from NIDA, and all participants provide informed consent and meet safety criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be between the ages of 18 and 60 years old
* Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level greater than 10 ppm indicative of recent smoking
* Have not received substance abuse treatment within the previous 30 days
* Meet criteria for Tobacco Use Disorder as determined by the Mini International Neuropsychiatric Interview (MINI): meeting 4 or more of the 11 diagnostic symptoms of Tobacco Use Disorder within a 12-month period
* If female, test non-pregnant
* 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 a response of "very likely" or "somewhat likely" on the Motivation to Stop Scale (scores 4-7)

Exclusion Criteria:

* Meeting MINI diagnostic criteria for any non-tobacco substance use disorder other than Caffeine Use Disorder, Cannabis Use Disorder - Mild, or Alcohol Use Disorder - Mild (Mild defined as meeting 2 to 3 of the 11 diagnostic symptoms within a 12-month period)
* Contraindications to MRI (e.g., metal in the skull, orbital, or intracranial cavity, or claustrophobia)
* Contraindication to repetitive TMS
* History of autoimmune, endocrine, viral, or vascular disorders affecting the brain
* History or MRI evidence of a neurological disorder causing 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 as confirmed by the MINI, including bipolar affective disorder, schizophrenia, post-traumatic stress disorder, suicidal ideation, or major depression
* Current use of tobacco cessation pharmacotherapies, including nicotine patches, electronic cigarettes, gum, nasal spray, inhalers, nicotine lozenges, varenicline, or bupropion
* Previous treatment with TMS

Where it's running

• Rutgers University Center for Molecular and Behavioral Neuroscience
  Newark, New Jersey, United States Recruiting

Study contacts

• Study coordinator: TRAVIS BAKER, PhD
• Email: travis.e.baker@rutgers.edu
• Phone: 9733533385

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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.