rTMS-concurrent Behavioral Priming for Reducing Smoking Cravings

NCT06228235 | Recruiting FDA Device

• 1 other identifier: 2301715815
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot clinical trial is to test the effects of different types of thinking strategies at the time of repetitive Transcranial Magnetic Stimulation (rTMS), applied to the left Dorsolateral Prefrontal Cortex (DLPFC), on smoking craving and brain activity. Participants will be individuals with moderate to high smoking dependence (smoking at least 8 cigarettes a day) who have no intention of quitting in the next 3 months and are eligible to have rTMS and functional magnetic resonance imaging (fMRI). The main objectives of the trial are:

• upregulation of craving while viewing smoking-related images
• downregulation of craving while viewing smoking-related images
• no regulation of craving while viewing neutral smoking-unrelated images The order of sessions will be randomized across participants.

Conditions

Smoking Reduction; Smoking Behaviors

Outcome Measures

Primary Outcomes (2)

• Change in self-reported smoking cravings

  Change in self-reported smoking cravings following high-frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex paired with upregulation of craving during smoking cue exposure and downregulation of craving during smoking cue exposure relative to neutral cue exposure and no regulation of craving. Craving will be rated using the Tobacco Craving Questionnaire immediately following rTMS and on 1-4 Likert scale (1 = not at all; 4 = very much) in the course of cue exposure in fMRI.

  within 1 hour following the delivery of rTMS

• Change in neural activation during regulation of craving

  Change in neural activation accompanying regulation of craving following high-frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex paired with upregulation of craving during smoking cue exposure and downregulation of craving during smoking cue exposure relative to neurtral cue exposure and no regulation of craving. Neural activation will be measured using functional magnetic resonance imaging (fMRI).

  within 1 hour following the delivery of rTMS

Secondary Outcomes (2)

• Change in delay discounting performance for cigarettes

  within 1 hour following the delivery of rTMS

• Change in neural activation during delay discounting performance for cigarettes

  within 1 hour following the delivery of rTMS

Other Outcomes (1)

• Resting-state brain activity

  within 1 hour following the delivery of rTMS

Study Arms (1)

Active rTMS

EXPERIMENTAL

There is a single arm in this open-label pilot study. All participants will receive active rTMS paired with different types of behavioral priming (upregulation of craving, downregulation of craving, no regulation of craving).

Device: Repetitive transcranial magnetic stimulation (rTMS)

Interventions

Repetitive transcranial magnetic stimulation (rTMS) DEVICE

rTMS: rTMS is a form of non-invasive brain modulation. High-frequency rTMS will be administered. Pulses will be delivered at the frequency of 20Hz, in 50 trains of 40 pulses, 2000 pulses in total. Behavioral priming with regulation of craving: During rTMS, participants will look at pictures either related or unrelated to smoking. When looking at pictures related to smoking, participants will either upregulate cravings by thinking about the immediate positive experience of smoking or downregulate cravings by thinking about long-term negative consequences of smoking. When looking at neutral pictures unrelated to smoking, participants will not regulate their cravings.

Also known as: Behavioral priming with regulation of craving

Active rTMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26505, United States

RECRUITING

MeSH Terms

Conditions

Smoking Reduction; Smoking

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Mariya V Cherkasova, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariya V Cherkasova, PhD

CONTACT

240-367-3068; mariya.cherkasova@mail.wvu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: April 16, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)