Using brain stimulation and thinking strategies to reduce smoking cravings

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot clinical trial aims to evaluate the effects of different cognitive strategies during repetitive Transcranial Magnetic Stimulation (rTMS) applied to the left Dorsolateral Prefrontal Cortex (DLPFC) on smoking cravings and brain activity. Participants, who are moderate to heavy smokers with no intention to quit in the near future, will engage in either 'upregulation' or 'downregulation' of cravings while exposed to smoking-related images during rTMS sessions. The study will compare these strategies against a control condition where participants view neutral images. The trial will also assess changes in brain activity using functional magnetic resonance imaging (fMRI).

Why it matters

Who can join: the full rules

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

Where it's running

• West Virginia University
  Morgantown, West Virginia, United States Recruiting

Study contacts

• Principal investigator: Mariya V Cherkasova, PhD — West Virginia University
• Study coordinator: Mariya V Cherkasova, PhD
• Email: mariya.cherkasova@mail.wvu.edu
• Phone: 240-367-3068

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.