Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)
A legfontosabb adatok
- Ki végzi
- Massachusetts General Hospital
- Hol
- Boston (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Fázis
- 4. fázis
- Résztvevők
- 30 fő, tervezett
- Kezdés
- 2026. júl. 2.
- Várható befejezés
- 2028. dec.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Varenicline
- Transcranial Magnetic Stimulation
- Transcranial Magnetic Stimulation Sham
- Nicotine Cessation Counseling
- D-cycloserine
- A regiszteradat frissítve
- 2026. szeptember 15.
Ki vehet részt
- Életkor
- 18 év – 65 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 20 feltétel megnézéseKevesebb
Ki vehet részt
- Age ≥ 18 and ≤65
- The ability to give written, informed consent
- Fluency in English
- Reported interest in quitting nicotine vaping or smoking within the next month
- Nicotine dependence, as defined by a score of ≥4 on the 10-question E-cigarette Dependence Inventory (ECDI) or Fagerström Test for Nicotine Dependence (FTND)
- Smoke or vape nicotine daily for at least the past 90 days, as confirmed by self-report and timeline follow-back methods
- Saliva cotinine >30ng/mL
Ki nem vehet részt
- Prior adverse drug reaction to varenicline
- Receiving or planning to receive other TMS treatments or investigational drugs during course of participation
- Contraindications to MRI (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia)
- Contraindication to D-Cycloserine (including allergy to D-Cycloserine, significant renal impairment or known kidney disease, pregnancy)
- Contraindications to TMS (including seizures, metallic implants, severe existing tinnitus, etc.)
- Inpatient psychiatric hospitalization or suicide attempts in the past six months, or recent active suicidal ideation or suicidal behavior identified at enrollment or baseline visits
- History of seizures and/or history of TBI subtypes associated with elevated seizure risk (e.g. penetrating injury and intraparenchymal hemorrhage)
- History of unstable neurological illness or major medical illness, such as epilepsy or renal impairment, in the past six months, unless clearly resolved
- Pregnancy or breastfeeding
- Use of smoking cessation pharmacotherapy in the past month
- Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study
- In the opinion of the investigators, evidence of active problem substance use severe enough to compromise ability to safely participate
- In the opinion of the investigators, unable to safely participate in this study and/or provide reliable data (e.g., claustrophobia, unable to tolerate TMS or MRI procedures, etc.)
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 65 év között vagy?
Helyszínek itt: Egyesült Államok
- Massachusetts General HospitalBoston, Egyesült ÁllamokContact: Jodi M Gilman, PhDRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
The goal of this clinical trial is to learn if a combination of varenicline and enhanced accelerated Transcranial Magnetic Stimulation (aTMS) works to help adults quit using nicotine products. Researchers will compare varenicline + active aTMS with a single dose of D-Clycloserine to varenicline + sham (inactive) aTMS with a placebo pill to see the effect of enhanced aTMS on reaching abstinence. The main question it aims to answer is: Does receiving active enhanced aTMS + varenicline lead to higher abstinence rates and lower nicotine craving?
A teljes eredeti leírásKevesebb
Participants will be asked to:
* Complete 2 brain MRI scans * Take varenicline every day for 12 weeks * Quit using nicotine products at the end of the second week of varenicline * Complete one day of up to 20 TMS treatments * Take a single dose of D-Cycloserine medication on the day of TMS treatment * Complete 12 brief, weekly study visits * Complete 6 brief, monthly follow up visits * Complete a brief daily survey each day that they take the study drug
A vizsgálat 2 csoportja
- Varenicline + Active Enhanced TMSMár használt kezelés, összehasonlításként
In this arm, participants will take 12 weeks of varenicline. They will also receive a single dose of 125 mg D-Cycloserine and one day of up to 20 TMS treatments, adjusted to an individualized target specific to the participant based on their brain MRI collected at the baseline imaging visit. Participants will also receive 12 brief nicotine cessation counseling sessions.
Kezelés: Varenicline, Transcranial Magnetic Stimulation, Nicotine Cessation Counseling és D-cycloserine
- Varenicine + Sham TMSSzínlelt kezelés, összehasonlításként
In this arm, participants will receive 12 weeks of varenicline and instructions on how to take it. They will also receive one day of up to 20 TMS treatments, adjusted to an individualized target specific to the participant based on their brain MRI collected at the baseline imaging visit. However, the sham setting will deliver no magnetic field to the brain; instead, it will deliver electrical current to the scalp to mimic the feel of active treatment. Participants will also receive 12 brief nicotine cessation counseling sessions.
Kezelés: Varenicline, Transcranial Magnetic Stimulation Sham és Nicotine Cessation Counseling
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.
- Hivatalos cím
- Evaluation of Varenicline and Accelerated TMS for Reduction of Nicotine Use
- Illeszkedési kérdések
- Forrás: NCT07145866: ki vehet részt
- A regiszteradat frissítve
- 2026. szeptember 15.