Modulating Neural Mechanisms of Reward Processing in Tobacco Users
ConditionTobacco Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorRutgers, The State University of New Jersey
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PRIME TMS
DeviceRepetitive 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
DeviceRepetitive 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.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: PRIME TMS (Personalized Connectivity-Based Targeting)Experimental treatment 1 intervention
Group B: Standard TMS (Anatomical Targeting)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Reward Positivity Amplitude
Reward positivity, an event-related potential (ERP) component measured via EEG during a virtual T-maze reward task, reflecting midcingulate cortex sensitivity to reward. Change from baseline to post-intervention will be compared between the PRIME TMS and Standard TMS arms.
Time frame
Baseline (Day 1, prior to Session 1) and Day 19 (within 3 days following completion of the 15-TMS sessions course), approximately Weeks 1 and 6Secondary outcomes
1
Change in Tobacco Craving Questionnaire (TCQ) Score
Multidimensional self-report measure of cigarette craving, including emotionality, expectancy, compulsivity, and purposefulness subscales. Total score ranges from 12 to 84 (4 subscales, ranging from 3 to 21), with higher scores indicating greater craving
Time frame
Baseline (Day 1, prior to Session 1) and Day 19 (within 3 days following completion of the 15-session course), with follow-up at approximately Week 1 and Week 6.2
Change in Questionnaire of Smoking Urges-Brief (QSU-B) Score
10-item Self-report measure of urge to smoke, assessing hedonic craving and anticipated relief from negative affect/withdrawal. Total score ranges from 10 to 70, with higher scores indicating greater urge to smoke.
Time frame
Baseline (Day 1, prior to Session 1) and Day 19 (within 3 days following completion of the 15-TMS session course), with follow-up at approximately Week 1 and Week 6.3
Change in Daily Cigarette Consumption
Self-reported cigarettes smoked per day, captured via daily tobacco diary and Timeline Follow-Back interview, corroborated with breath carbon monoxide level.
Time frame
Baseline through 1-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rutgers, The State University of New Jersey
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov