Using brain stimulation and thinking strategies to reduce smoking cravings
Optimizing the rTMS-concurrent Behavioral Priming for Reducing Smoking Cravings
This study is trying to see if using brain stimulation along with different thinking strategies can help moderate to heavy smokers feel less craving for cigarettes when they look at smoking-related images.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | West Virginia University Academic / other |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT06228235 on ClinicalTrials.gov |
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).
Who should consider this trial
Good fit: Ideal candidates are active smokers consuming at least 8 cigarettes a day for at least 6 months and who are not planning to quit in the next 3 months.
Not a fit: Patients with a history of epilepsy, severe brain injuries, or significant mental health disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly help smokers manage their cravings and reduce smoking behavior.
How similar studies have performed: While the specific combination of rTMS and cognitive strategies is novel, similar studies using rTMS for addiction treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Morgantown, West Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.