RECRUITING Not applicable ClinicalTrials.gov

Modulating Neural Mechanisms of Reward Processing in Tobacco Users

Sponsor: Rutgers, The State University of New Jersey • ClinicalTrials.gov ID: NCT07812753

Registry updated: 2026-09-10

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

The goal of this clinical trial is to learn if a personalized, brain-scan-guided form of transcranial magnetic stimulation (TMS) works better than a standard TMS approach at changing reward-related brain activity in adults who smoke cigarettes. The main questions it aims to answer are: Does personalized TMS produce a greater change in reward-related brain activity than the standard approach? Does personalized TMS lead to a greater reduction in cravings and cigarette smoking than the standard approach? Researchers will compare personalized TMS, which targets a treatment location chosen from each participant's own brain scan, to a standard TMS approach, which targets a location based on anatomical landmarks, to see if the personalized approach produces stronger effects on brain reward activity and smoking behavior. Participants will: Complete an magnetic resonance imaging (MRI) brain scan and questionnaires about their smoking habits and mood Be randomly assigned to receive either personalized TMS or the standard TMS approach Attend 15 TMS treatment sessions over 3 weeks (Monday through Friday), including brain wave (EEG) recordings and craving check-ins before and after each session Return for follow-up visits 1 week and 1 month after finishing treatment

Interventions

PRIME TMS (Device)
Repetitive TMS (10 Hz, 3,000 pulses per session, 110% resting motor threshold) delivered via a figure-8 coil using robotic neuronavigation. The stimulation target is an individualized dorsolateral prefrontal cortex location identified from each participant's diffusion-weighted MRI as having maximal structural connectivity to the midcingulate cortex. Delivered over 15 sessions across 3 weeks, concurrently with a brief reward-based cognitive task performed during inter-train intervals.
Standard TMS (Device)
Repetitive transcranial magnetic stimulation (10 Hz, 3,000 pulses per session, 110% resting motor threshold) delivered via a figure-8 coil using robotic neuronavigation. The stimulation target is a dorsolateral prefrontal cortex location identified using standardized anatomical landmarks on structural MRI, without individualized connectivity mapping. Delivered over 15 sessions across 3 weeks, without a concurrent cognitive task.

Eligibility criteria

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

Conditions

Tobacco Use Disorder

Locations

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

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment