Recruiting

TMS

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06695884

Conditions

Nicotine Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Study Details

Brief summary:

The primary goal will be to identify the optimal pulse protocol by systematically measuring the efficacy of various theta burst stimulation and repetitive rTMS protocols to increase and decrease the reward positivity in dependent smokers. The secondary objective will be to measure the protocols' effectiveness to increase decision-making capacity using the probabilistic selection task (PST). The third objective will be to specifically assess whether the TMS targets has a differential impact on state levels of craving relative to baseline (Tobacco Craving Questionnaire \[TCQ\]. The investigators plan to accomplish these three objectives using a randomized, controlled experiment involving 2 sessions.

Conditions

Nicotine Use Disorder

Study ID

NCT06695884

Start date

Aug 1, 2024

Status verified date

Nov, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Nicotine dependent individuals (according to the Alcohol, Smoking and Substance Involvement Screening Test nicotine dependence score).
2. Be between the ages of 18 and 55 years old.
3. Not received substance abuse treatment within the previous 30 days.
4. Be in stable mental and physical health.
5. If female, test non-pregnant.
6. No evidence of focal or diffuse brain lesion on MRI.
7. Be willing to provide informed consent.
8. Be able to comply with protocol requirements and likely to complete all study procedures.

Exclusion Criteria:

1. Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
2. Contraindication to rTMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \> 15 minutes, implanted electronic device, metal in the head, or pregnancy).
3. History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
4. History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
5. Life time history of mental disorders such as: Bipolar Affective disorder (BPAD), Schizophrenia, Post-traumatic Stress disorder (PTSD) or Dementia or Major Depression.
6. uninterruptable central nervous system medication

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Excitatory TMS

For condition 1a, 3600 pulses of 10-Hz TMS or 3600 pulses of cTBS. 10 Hz rTMS (110% RMT stimulation intensity; 10 Hz frequency; 5 s on and 26 s off; 3600 pulses per session; total duration of 40 min). cTBS (80% RMT, (3 pulses at 50 Hz with a repeated frequency of 5 Hz, 200 ms intervals, containing 1800 pulses, 60 second break, 1800 pulses; total duration of 5 minutes).

experimental: Inhibitory TMS

For condition 1b, 600 or 1200 pulses of iTBS. iTBS will be administered at 80% of each participant's RMT in a burst-firing pattern (3 pulses at 50 Hz) for a 2 s train, followed by an 8 s period of rest. Across sessions, participants will receive one of two iTBS protocols (randomized): 600 pulses (190 s) or 1200 pulses (570 s).

Interventions

Transcranial Magnetic Stimulation

TMS will be delivered using a robotic neuronavigation system (Smartmove, ANT). Stimulation intensity will be standardized. Stimulation will be delivered to the L-DLPFC using a active/placebo figure-8 coil and a magventure TMS device.

Primary outcome measure

  • Event-related Brain Potential: Reward Positivity [ Time Frame: Day 0 (day of testing) ]

Central Contacts and Locations

Locations

Rutgers University - Newark

Recruiting

Newark, New Jersey, United States, 07102

Contacts

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

  • transcranial magnetic stimulation
  • reward processing
  • EEG
  • smoking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-11-18.