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

4 september 2026 uppdaterad av: 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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

54

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: 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.
Aktiv 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.
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Reward Positivity Amplitude
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Tobacco Craving Questionnaire (TCQ) Score
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Rutgers, The State University of New Jersey

Samarbetspartners

National Institute on Drug Abuse (NIDA)

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 juli 2026

Primärt slutförande (Beräknad)

15 juli 2029

Avslutad studie (Beräknad)

15 juli 2029

Studieregistreringsdatum

Först inskickad

1 september 2026

Först inskickad som uppfyllde QC-kriterierna

4 september 2026

Första postat (Faktisk)

10 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Pro2026000200
  • 4UH3DA054787-03 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

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