Smoking ReductionNCT06228235
rTMS-concurrent Behavioral Priming for Reducing Smoking Cravings
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Smoking Reduction and Smoking Behaviors, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Smoking Reduction, Smoking Behaviors
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
West Virginia University
Morgantown, West Virginia, 26505
Mariya V Cherkasova, PhD, 2403673068, mariya.cherkasova@mail.wvu.edu
Mariya V Cherkasova, PhD
About this study
Official title: Optimizing the rTMS-concurrent Behavioral Priming for Reducing Smoking Cravings
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:
- To compare the craving-reducing effects of "upregulation" and "downregulation" of craving while looking at pictures related to cigarette smoking during rTMS versus no regulation of craving while looking at neutral pictures unrelated to smoking. 'Upregulation" is thinking about the immediate positive experience of smoking. "Downregulation" is thinking about the long-term negative consequences of smoking.
- To examine changes in brain activity that accompany craving reductions produced by rTMS paired with upregulation and downregulation of craving while looking at pictures related to cigarette smoking versus no regulation of craving while looking at neutral pictures unrelated to smoking.
Read more
Following screening for eligibility, participants will be trained on how to do upregulation and downregulation of craving. The participants will then participate in 3 testing sessions. In each session, the participants will receive rTMS at 20Hz in 50 trains (2000 pulses total), followed immediately by fMRI. Sessions will take place 1-2 weeks apart and will differ in the type of thinking strategy participants will use while looking at pictures during the rTMS:
- 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
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS)
- Medical subject headings
- Smoking Reduction, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Device
Also called Behavioral priming with regulation of craving
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: within 1 hour following the delivery of rTMS
Secondary outcomes (2)
Change in delay discounting performance for cigarettes
Change in delay discounting performance for cigarettes 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. Delay discounting performance will be measured in fMRI using a delay discounting task optimized for fMRI with the commodity being cigarettes.
Measured: within 1 hour following the delivery of rTMS
Change in neural activation during delay discounting performance for cigarettes
Change in neural activation accompanying delay discounting performance for cigarettes 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. Neural activation will be measured using fMRI.
Measured: within 1 hour following the delivery of rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start16 Apr 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariya V. Cherkasova, West Virginia University
- Investigators
- Mariya V Cherkasova, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228235
- Sponsor's protocol ID
- 2301715815
- Status last verified
- Apr 2025
- First submitted
- 19 Jan 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the rTMS-concurrent Behavioral Priming for Reducing Smoking Cravings
- ClinicalTrials.gov ID
- NCT06228235
- Acronym / sponsor ID
- 2301715815
- Conditions
- Smoking Reduction, Smoking Behaviors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare the craving-reducing effects of "upregulation" and "downregulation" of craving while looking at pictures related to cigarette smoking during rTMS versus no regulation of craving while looking at neutral pictures unrelated to smoking. 'Upregulation" is thinking about the immediate positive experience of smoking. "Downregulation" is thinking about the long-term negative consequences of smoking.
- To examine changes in brain activity that accompany craving reductions produced by rTMS paired with upregulation and downregulation of craving while looking at pictures related to cigarette smoking versus no regulation of craving while looking at neutral pictures unrelated to smoking.
Following screening for eligibility, participants will be trained on how to do upregulation and downregulation of craving. The participants will then participate in 3 testing sessions. In each session, the participants will receive rTMS at 20Hz in 50 trains (2000 pulses total), followed immediately by fMRI. Sessions will take place 1-2 weeks apart and will differ in the type of thinking strategy participants will use while looking at pictures during the rTMS:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS)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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS)Also: Behavioral priming with regulation of cravingrTMS: 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. | Device | Active rTMS |
Primary outcome
Change in self-reported smoking cravings
Time frame: within 1 hour following the delivery of rTMS
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.
Change in neural activation during regulation of craving
Time frame: within 1 hour following the delivery of rTMS
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).
2 secondary outcomes
Change in delay discounting performance for cigarettes
Time frame: within 1 hour following the delivery of rTMS
Change in neural activation during delay discounting performance for cigarettes
Time frame: within 1 hour following the delivery of rTMS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Smoking Reduction
Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders
Recruiting
A Study to Determine the Effect of Access to Multiple Tobacco Flavor Options on Smoking Abstinence Among Primary Cigarette Smokers Using an Electronic Nicotine Delivery System
Smoking, Tobacco
Enrolling by invitation
Clinical Alternatives for Reducing Harm Using E-cigarettes
Smoking, E-Cig Use
RecruitingPhase 3
Switching to E-cigarettes in Smokers Not Interested in Quitting
Smoking Reduction
Recruiting
The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
Smoking Reduction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariya V Cherkasova, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Smoking Reduction and Smoking Behaviors, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariya V Cherkasova, PhD (240-367-3068, mariya.cherkasova@mail.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported smoking cravings (time frame: within 1 hour following the delivery of rTMS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.