Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

4. September 2026 aktualisiert von: 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

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

54

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: 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.
Aktiver 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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Reward Positivity Amplitude
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Tobacco Craving Questionnaire (TCQ) Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Rutgers, The State University of New Jersey

Mitarbeiter

National Institute on Drug Abuse (NIDA)

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. Juli 2026

Primärer Abschluss (Geschätzt)

15. Juli 2029

Studienabschluss (Geschätzt)

15. Juli 2029

Studienanmeldedaten

Zuerst eingereicht

1. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. September 2026

Zuerst gepostet (Tatsächlich)

10. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Pro2026000200
  • 4UH3DA054787-03 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren