Modulating Neural Mechanisms of Reward Processing in Tobacco Users
A legfontosabb adatok
- Ki végzi
- Rutgers, The State University of New Jersey
- Hol
- Newark (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 54 fő, tervezett
- Kezdés
- 2026. júl. 24.
- Várható befejezés
- 2029. júl. 15.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- PRIME TMS
- Standard TMS
- A regiszteradat frissítve
- 2026. szeptember 10.
Ki vehet részt
- Életkor
- 18 év – 60 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 18 feltétel megnézéseKevesebb
Ki vehet részt
- 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)
Ki nem vehet részt
- Previous treatment with TMS
- 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)
- 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
- Contraindications to MRI (e.g., metal in the skull, orbital, or intracranial cavity, or claustrophobia)
- Contraindication to repetitive TMS
- Current use of tobacco cessation pharmacotherapies, including nicotine patches, electronic cigarettes, gum, nasal spray, inhalers, nicotine lozenges, varenicline, or bupropion
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 60 év között vagy?
Helyszínek itt: Egyesült Államok
- Rutgers University Center for Molecular and Behavioral NeuroscienceNewark, Egyesült ÁllamokContact: Travis Baker, PhDRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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:
A teljes eredeti leírásKevesebb
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
A vizsgálat 2 csoportja
- PRIME TMS (Personalized Connectivity-Based Targeting)A vizsgált kezelés
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.
Kezelés: PRIME TMS
- Standard TMS (Anatomical Targeting)Már használt kezelés, összehasonlításként
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.
Kezelés: Standard TMS
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Illeszkedési kérdések
- Forrás: NCT07812753: ki vehet részt
- A regiszteradat frissítve
- 2026. szeptember 10.