💬In plain words
What the trial is, and whether it could suit you
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?
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
* Comple
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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;
Exclusion Criteria:
* 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;
* Prior adverse drug reaction to varenicline;
* Contraindication to D-Cycloserine (including allergy to D-Cycloserine, significant renal impairment or known kidney disease, pregnancy)
* Receiving or planning to receive other TMS treatments or investigational drugs during course of participation
* Contraindications to TMS (including seizures, metallic implants, severe existing tinnitus, etc.);
* 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);
* 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;
* 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.).
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