Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT06228235
Eligibility Criteria:
Inclusion Criteria:
* Able to provide written informed consent, and to follow study procedures
* Active cigarette smoker consuming at least 8 cigarettes a day for at least 6 months.
* Dual use of cigarettes and e-cigarettes is permitted.
Exclusion Criteria:
* History of epilepsy or seizure disorder
* History of cerebral vascular accident or cortical stroke
* History of brain lesions (such as multiple sclerosis, tumor)
* History of moderate or severe traumatic brain injury
* Possible DSM-5 Axis-I disorders as suggested by scores on the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure (41) exceeding any domain thresholds set by ratings of 2 or higher on individual item, with two exceptions. 1) For depression and anxiety, item scores of 3 or higher will be exclusionary. 2) For substance use (except nicotine/ tobacco and alcohol), item scores of 1 or higher will be exclusionary. For alcohol, the item score of 2 or higher will be the exclusionary.
* Active suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
* Pregnancy
* Positive urine toxicology for recreational drugs of abuse
* Shoulder-to-shoulder width of \> 60cm (24'') to ensure fit in the MRI scanner
* Positive responses to the TMS Screening Form or the MRI checklist that preclude participation at the discretion of the investigator
* Intracranial metallic objects (excluding dental fillings)
* Prior rTMS treatment
* Current treatment with varenicline or nicotine replacement therapy (NRT)
* A score of \> 6 on the Readiness to Quit Ladder (42) for smoking
* Intake of one or a combination of the following drugs presenting a 'Strong Potential Hazard' for application of rTMS due to their significant seizure threshold lowering potential:
* Imipramine, Amitriptyline, Doxepine, Nortriptyline, Maprotiline, Chlorpromazine, Clozapine, Foscarnet, Ganciclovir, Ritonavir, Amphetamines, Cocaine (MDMA, ecstasy), Phencyclidine (PCP, angel's dust), Ketamine, Gamma-hydroxybutyrate (GHB), Alcohol, Theophylline.
* The urine toxicology panel will verify the presence of some of these drugs prior to each rTMS session
* Recent withdrawal from one of the following drugs representing a 'Strong Relative Hazard' for application of rTMS due to the resulting significant seizure threshold lowering potential:
* Alcohol, Barbiturates, Benzodiazepines, Meprobamate, Chloral hydrate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06228235
Study Brief:
Protocol Section:
NCT06228235