Tobacco Use DisorderModRewTobNCT07812753
Modulating Neural Mechanisms of Reward Processing in Tobacco Users
A study testing PRIME TMS and Standard TMS in people with Tobacco Use Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- PRIME TMS and Standard TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2026to 15 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers University Center for Molecular and Behavioral Neuroscience
Newark, New Jersey, 07102
Travis Baker, PhD, 9733533385, travis.e.baker@rutgers.edu
travis.e.baker@rutgers.edu
About this study
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?
Read more
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
Read the detailed description
People with tobacco use disorder often show changes in how their brain responds to rewards. A brain region involved in this process can be measured using a brain wave (EEG) signal that reflects how strongly the brain reacts to rewards. This study looks at whether a personalized form of brain stimulation can shift that signal more effectively than a standard approach.
The personalized approach, Pathway-precise Reward Intervention via Midcingulate Engagement (PRIME) TMS uses each participant's own brain scan to find the stimulation location that is most strongly connected to the brain's reward center, rather than using the same general location for everyone. Stimulation is also paired with a short reward-based computer task during the session, based on the idea that engaging the brain's reward system during stimulation may strengthen its effects. The standard approach uses a fixed stimulation location based on external head landmarks and is delivered without any task.
Participants are randomly assigned to one of the two approaches, similar to a coin flip, with the assignment balanced to make sure both groups have similar mixes of smoking severity and mood symptoms. Both groups receive the same number of sessions (15), on the same schedule (weekdays for 3 weeks), and the same strength and dose of stimulation. The only differences are where the stimulation is delivered and whether participants complete a task during it.
Study visits include an initial screening, a brain scan to plan the intervention, a baseline visit with brain wave recording and questionnaires, the three weeks of stimulation sessions, a follow-up assessment shortly after the sessions end, and two brief check-in calls at 1 week and 1 month later. Throughout the study, the research team monitors participants closely for side effects using standardized safety checklists, and all equipment used (the stimulation device, positioning system, brain wave recorder, and MRI scanner) is already cleared by the FDA for other uses.
The study will compare how much each approach changes brain reward activity, cravings, and smoking amounts, and will look at whether changes in brain activity help explain any changes in cravings or smoking behavior.
- Conditions
- Tobacco Use Disorder
- Being tested
- PRIME TMS, Standard TMS
- Keywords
- Transcranial magnetic stimulation, Tobacco use disorder, Smoking cessation, reward processing, brain connectivity, Electroencephalography, Neuromodulation, Craving
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIME TMSDevice
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 TMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PRIME TMS (Personalized Connectivity-Based Targeting) | Experimental | Participants receive 15 sessions of 10 Hz repetitive TMS over 3 weeks (Monday-Friday), delivered at 110% of resting motor threshold. 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. Stimulation is delivered concurrently with a brief reward-based cognitive task performed during inter-train intervals, intended to engage the brain's reward circuitry during treatment. Receives: Device: PRIME TMS |
| Standard TMS (Anatomical Targeting) | Active comparator | Participants receive 15 sessions of 10 Hz repetitive TMS over 3 weeks (Monday-Friday), delivered at 110% of resting motor threshold. The stimulation target is a dorsolateral prefrontal cortex location identified using standardized anatomical landmarks on structural MRI, without individualized connectivity mapping. Stimulation is delivered without a concurrent cognitive task. This approach reflects a well-established TMS protocol with a long-standing published safety and efficacy record. Receives: Device: Standard TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 6
Secondary outcomes (3)
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
Measured: 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.
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.
Measured: 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.
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.
Measured: Baseline through 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start24 Jul 2026
- Primary completion15 Jul 2029 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to one of two parallel arms using a computerized, permuted-block procedure (block sizes of 4, 6, and 8), stratified by tobacco use disorder severity and psychiatric comorbidity status, yielding four strata. Both arms receive identical stimulation dose and schedule (10 Hz, 3,000 pulses per session, 110% resting motor threshold, 15 sessions over 3 weeks); the arms differ only in how the stimulation target is identified and whether a concurrent cognitive task is administered during stimulation. Because the two protocols are procedurally distinct in ways that are perceptible to participants and administering staff, the study is not fully blinded; however, staff who score EEG, behavioral, and clinical outcome data remain blinded to treatment assignment throughout.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Travis Baker, PhD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812753
- Sponsor's protocol ID
- Pro2026000200
- Other IDs
- 4UH3DA054787-03
- Acronym
- ModRewTob
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data will be shared, including: structural and diffusion-weighted MRI data; EEG recordings collected during the reward-based task at baseline and post-intervention; behavioral performance data from the reward task and the Probabilistic Selection Task; and questionnaire-based measures of craving (TCQ, QSU-B), smoking behavior (cigarette consumption, carbon monoxide levels), and nicotine dependence severity (FTND). All data will be stripped of direct identifiers, dates, and geographic identifiers smaller than state level prior to sharing, consistent with NIH data-sharing requirements.
Publications
Baker TE, Wood JMA, Holroyd CB. Atypical valuation of monetary and cigarette rewards in substance dependent smokers. Clin Neurophysiol. 2016 Feb;127(2):1358-1365. doi: 10.1016/j.clinph.2015.11.002. Epub 2015 Nov 11.
PubMed 26625969Baker TE, Lesperance P, Tucholka A, Potvin S, Larcher K, Zhang Y, Jutras-Aswad D, Conrod P. Reversing the Atypical Valuation of Drug and Nondrug Rewards in Smokers Using Multimodal Neuroimaging. Biol Psychiatry. 2017 Dec 1;82(11):819-827. doi: 10.1016/j.biopsych.2017.01.015. Epub 2017 Jan 27.
PubMed 28314439Baker TE, Zeighami Y, Dagher A, Holroyd CB. Smoking Decisions: Altered Reinforcement Learning Signals Induced by Nicotine State. Nicotine Tob Res. 2020 Feb 6;22(2):164-171. doi: 10.1093/ntr/nty136.
PubMed 29982681Biernacki K, Lin MH, Baker TE. Recovery of reward function in problematic substance users using a combination of robotics, electrophysiology, and TMS. Int J Psychophysiol. 2020 Dec;158:288-298. doi: 10.1016/j.ijpsycho.2020.08.008. Epub 2020 Oct 14.
PubMed 33068631
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Neural Mechanisms of Reward Processing in Tobacco Users
- ClinicalTrials.gov ID
- NCT07812753
- Acronym / sponsor ID
- ModRewTob / Pro2026000200
- Conditions
- Tobacco Use Disorder
- Keywords
- Transcranial magnetic stimulation, Tobacco use disorder, Smoking cessation, reward processing, brain connectivity, Electroencephalography, Neuromodulation, Craving
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- 15 Jul 2029 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
People with tobacco use disorder often show changes in how their brain responds to rewards. A brain region involved in this process can be measured using a brain wave (EEG) signal that reflects how strongly the brain reacts to rewards. This study looks at whether a personalized form of brain stimulation can shift that signal more effectively than a standard approach.
The personalized approach, Pathway-precise Reward Intervention via Midcingulate Engagement (PRIME) TMS uses each participant's own brain scan to find the stimulation location that is most strongly connected to the brain's reward center, rather than using the same general location for everyone. Stimulation is also paired with a short reward-based computer task during the session, based on the idea that engaging the brain's reward system during stimulation may strengthen its effects. The standard approach uses a fixed stimulation location based on external head landmarks and is delivered without any task.
Participants are randomly assigned to one of the two approaches, similar to a coin flip, with the assignment balanced to make sure both groups have similar mixes of smoking severity and mood symptoms. Both groups receive the same number of sessions (15), on the same schedule (weekdays for 3 weeks), and the same strength and dose of stimulation. The only differences are where the stimulation is delivered and whether participants complete a task during it.
Study visits include an initial screening, a brain scan to plan the intervention, a baseline visit with brain wave recording and questionnaires, the three weeks of stimulation sessions, a follow-up assessment shortly after the sessions end, and two brief check-in calls at 1 week and 1 month later. Throughout the study, the research team monitors participants closely for side effects using standardized safety checklists, and all equipment used (the stimulation device, positioning system, brain wave recorder, and MRI scanner) is already cleared by the FDA for other uses.
The study will compare how much each approach changes brain reward activity, cravings, and smoking amounts, and will look at whether changes in brain activity help explain any changes in cravings or smoking behavior.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to one of two parallel arms using a computerized, permuted-block procedure (block sizes of 4, 6, and 8), stratified by tobacco use disorder severity and psychiatric comorbidity status, yielding four strata. Both arms receive identical stimulation dose and schedule (10 Hz, 3,000 pulses per session, 110% resting motor threshold, 15 sessions over 3 weeks); the arms differ only in how the stimulation target is identified and whether a concurrent cognitive task is administered during stimulation. Because the two protocols are procedurally distinct in ways that are perceptible to participants and administering staff, the study is not fully blinded; however, staff who score EEG, behavioral, and clinical outcome data remain blinded to treatment assignment throughout.
| Arm | Type | Receives |
|---|---|---|
| PRIME TMS (Personalized Connectivity-Based Targeting) | Experimental | Device: PRIME TMSParticipants receive 15 sessions of 10 Hz repetitive TMS over 3 weeks (Monday-Friday), delivered at 110% of resting motor threshold. 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. Stimulation is delivered concurrently with a brief reward-based cognitive task performed during inter-train intervals, intended to engage the brain's reward circuitry during treatment. |
| Standard TMS (Anatomical Targeting) | Active comparator | Device: Standard TMSParticipants receive 15 sessions of 10 Hz repetitive TMS over 3 weeks (Monday-Friday), delivered at 110% of resting motor threshold. The stimulation target is a dorsolateral prefrontal cortex location identified using standardized anatomical landmarks on structural MRI, without individualized connectivity mapping. Stimulation is delivered without a concurrent cognitive task. This approach reflects a well-established TMS protocol with a long-standing published safety and efficacy record. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIME TMSRepetitive 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. | Device | PRIME TMS (Personalized Connectivity-Based Targeting) |
| Standard TMSRepetitive 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. | Device | Standard TMS (Anatomical Targeting) |
Primary outcome
Change in Reward Positivity Amplitude
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 6
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.
3 secondary outcomes
Change in Tobacco Craving Questionnaire (TCQ) Score
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.
Change in Questionnaire of Smoking Urges-Brief (QSU-B) Score
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.
Change in Daily Cigarette Consumption
Time frame: Baseline through 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 26625969Baker TE, Wood JMA, Holroyd CB. Atypical valuation of monetary and cigarette rewards in substance dependent smokers. Clin Neurophysiol. 2016 Feb;127(2):1358-1365. doi: 10.1016/j.clinph.2015.11.002. Epub 2015 Nov 11.
- Background: PubMed 28314439Baker TE, Lesperance P, Tucholka A, Potvin S, Larcher K, Zhang Y, Jutras-Aswad D, Conrod P. Reversing the Atypical Valuation of Drug and Nondrug Rewards in Smokers Using Multimodal Neuroimaging. Biol Psychiatry. 2017 Dec 1;82(11):819-827. doi: 10.1016/j.biopsych.2017.01.015. Epub 2017 Jan 27.
- Background: PubMed 29982681Baker TE, Zeighami Y, Dagher A, Holroyd CB. Smoking Decisions: Altered Reinforcement Learning Signals Induced by Nicotine State. Nicotine Tob Res. 2020 Feb 6;22(2):164-171. doi: 10.1093/ntr/nty136.
- Background: PubMed 33068631Biernacki K, Lin MH, Baker TE. Recovery of reward function in problematic substance users using a combination of robotics, electrophysiology, and TMS. Int J Psychophysiol. 2020 Dec;158:288-298. doi: 10.1016/j.ijpsycho.2020.08.008. Epub 2020 Oct 14.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared, including: structural and diffusion-weighted MRI data; EEG recordings collected during the reward-based task at baseline and post-intervention; behavioral performance data from the reward task and the Probabilistic Selection Task; and questionnaire-based measures of craving (TCQ, QSU-B), smoking behavior (cigarette consumption, carbon monoxide levels), and nicotine dependence severity (FTND). All data will be stripped of direct identifiers, dates, and geographic identifiers smaller than state level prior to sharing, consistent with NIH data-sharing requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIME TMS and Standard TMS in people with Tobacco Use Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TRAVIS BAKER, PhD (9733533385, travis.e.baker@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reward Positivity Amplitude (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 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07812753, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.