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Modulating Neural Mechanisms of Reward Processing in Tobacco Users (ModRewTob)

4 września 2026 zaktualizowane przez: Travis Baker, PhD, Rutgers, The State University of New Jersey

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

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

54

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: PRIME TMS (Personalized Connectivity-Based Targeting)
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.
Urządzenie: PRIME TMS
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.
Aktywny komparator: Standard TMS (Anatomical Targeting)
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.
Urządzenie: Standard TMS
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Reward Positivity Amplitude
Ramy czasowe: 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.
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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Tobacco Craving Questionnaire (TCQ) Score
Ramy czasowe: 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.
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
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
Ramy czasowe: 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.
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.
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
Ramy czasowe: Baseline through 1-month follow-up
Self-reported cigarettes smoked per day, captured via daily tobacco diary and Timeline Follow-Back interview, corroborated with breath carbon monoxide level.
Baseline through 1-month follow-up

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Rutgers, The State University of New Jersey

Współpracownicy

National Institute on Drug Abuse (NIDA)

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

24 lipca 2026

Zakończenie podstawowe (Szacowany)

15 lipca 2029

Ukończenie studiów (Szacowany)

15 lipca 2029

Daty rejestracji na studia

Pierwszy przesłany

1 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 września 2026

Pierwszy wysłany (Rzeczywisty)

10 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Pro2026000200
  • 4UH3DA054787-03 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

Data will be prepared for repository deposit and made available beginning 12-18 months after study completion, or upon publication of primary results, whichever occurs first. Once deposited, de-identified data will remain available indefinitely, consistent with NIH data-retention requirements for de-identified research data. No end date is specified for data availability.

Kryteria dostępu do udostępniania IPD

Access will be limited to qualified researchers who submit a data use request through the applicable repository (OpenNeuro for neuroimaging data; NIMH Data Archive for behavioral, EEG, and questionnaire data). Applicants must agree to the repository's data use agreement, restricting use to approved research purposes and prohibiting re-identification attempts. Requests are reviewed and approved by repository administrators, not directly by the study team.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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