Search / Trial NCT06228235

rTMS-concurrent Behavioral Priming for Reducing Smoking Cravings

Launched by WEST VIRGINIA UNIVERSITY · Jan 19, 2024

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring new ways to help people reduce their cravings for cigarettes using a technique called repetitive Transcranial Magnetic Stimulation (rTMS) combined with different thinking strategies. The study focuses on individuals who smoke at least 8 cigarettes a day and are not planning to quit in the next three months. Participants will learn two techniques: "upregulation," where they think about the immediate pleasure of smoking, and "downregulation," where they reflect on the long-term harm of smoking. They will take part in three sessions, each involving rTMS and looking at different types of images related or unrelated to smoking, to see how these strategies affect cravings and brain activity.

To join the study, participants need to be able to provide consent and have been smoking regularly for at least six months. However, certain conditions like a history of seizures or severe brain injuries, pregnancy, or recent substance use may disqualify someone from participating. Those who are eligible will undergo training before their testing sessions, which will occur over several weeks. This study aims to better understand how these thinking strategies might help manage cravings and support smokers in their journey toward reducing their smoking behavior.

Gender

ALL

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

Trial Officials

Mariya V Cherkasova, PhD

Principal Investigator

West Virginia University

About West Virginia University

West Virginia University (WVU) is a leading research institution dedicated to advancing healthcare through innovative clinical trials and research initiatives. With a strong commitment to improving patient outcomes, WVU harnesses its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies across a wide range of medical fields. The university collaborates with healthcare providers, industry partners, and regulatory bodies to ensure the highest standards of ethics and scientific integrity in its research endeavors. WVU strives to translate scientific discoveries into practical applications, ultimately enhancing the quality of care for diverse populations in West Virginia and beyond.

Locations

Morgantown, West Virginia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0