64 Participants Needed

rTMS for Smoking Cessation

XL
Overseen ByXingbao Li, MD, MSCR, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers. In this study, investigators will use brain MRI to guide TMS therapy for smoking cessation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those with moderate to severe substance use of psychoactive substances other than nicotine or caffeine.

What data supports the effectiveness of this treatment for smoking cessation?

Research shows that repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) can reduce cigarette cravings and consumption. Studies found that rTMS significantly decreased the number of cigarettes smoked and increased the quit rate among smokers.12345

Is rTMS safe for smoking cessation?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for humans, as it has been used in various studies for smoking cessation and other conditions like depression. Participants in these studies did not report significant safety concerns, and the treatment has been cleared by the US Food and Drug Administration for smoking cessation.46789

How does the rTMS treatment for smoking cessation differ from other treatments?

The rTMS treatment for smoking cessation is unique because it uses magnetic pulses to stimulate specific areas of the brain, like the prefrontal cortex, to reduce cravings and cigarette consumption. Unlike traditional methods such as nicotine replacement or medications, rTMS is non-invasive and targets brain circuits involved in addiction, showing promising results in increasing quit rates.456810

Research Team

XL

Xingbao Li, M.D

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for adults aged 18-60 who smoke at least 10 cigarettes daily, want to quit smoking, and are in stable health. They must not have had substance abuse treatment recently or use other nicotine products. Pregnant women or those with certain medical conditions like severe heart disease, brain lesions, or metal implants that interfere with MRI scans cannot participate.

Inclusion Criteria

Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level > 10 ppm indicative of recent smoking
Be able to comply with protocol requirements and likely to complete all study procedures
Have not received substance abuse treatment within the previous 30 days
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Exclusion Criteria

I have a history of brain-related autoimmune, endocrine, viral, or vascular disorders.
I do not have severe heart, kidney, liver problems, or uncontrolled high blood pressure.
Current moderate to severe substance use of any psychoactive substances other than nicotine or caffeine, as defined by DSM-V criteria
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 20 daily sessions of rTMS over 4 weeks, with functional MRI scans performed before the first TMS treatment, after session 10, and after the last session.

4 weeks
20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at 1 week, 1 month, 2 months, 3 months, and 4 months after the last TMS session.

16 weeks
5 visits (in-person)

Treatment Details

Interventions

  • Active rTMS 10 Hz DLPFC
  • Active rTMS 1 Hz mOFC
  • Sham rTMS
Trial Overview The study tests if rTMS (a non-invasive brain stimulation) can help people stop smoking. Participants will receive either sham (fake) rTMS or active rTMS targeted at specific brain areas using MRI guidance to potentially reduce their craving for cigarettes.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Active rTMS 10 Hz DLPFCActive Control1 Intervention
A stimulation frequency of 10 Hz, pulse train duration (on time) of 5 seconds, inter-train interval (off time) of 10 seconds (15 second cycle time), E-field-modeling to determine TMS intensity and coil orientation, total of 60 trains, session time of 15 minutes, and 3000-total pulses per day, will be delivered over the left DLPFC.
Group II: Sham rTMSPlacebo Group1 Intervention
Investigators will use electrode stimulation with 10 Hz over DLPFC, total 3000 pulses. The sham-TMS scalp discomfort was matched to that of active TMS. During real TMS there was no current flowing through the scalp electrodes.

Active rTMS 10 Hz DLPFC is already approved in United States, Canada for the following indications:

🇺🇸
Approved in United States as rTMS for:
  • Short-term smoking cessation
🇨🇦
Approved in Canada as rTMS for:
  • Smoking cessation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

In a study involving 48 chronic smokers, ten daily sessions of high-frequency transcranial magnetic stimulation (rTMS) on the left dorsolateral prefrontal cortex significantly reduced cigarette consumption and nicotine dependence.
The rTMS treatment also effectively blocked cravings triggered by smoking-related cues, although the benefits appeared to decrease over time after the treatment ended.
Repeated high-frequency transcranial magnetic stimulation over the dorsolateral prefrontal cortex reduces cigarette craving and consumption.Amiaz, R., Levy, D., Vainiger, D., et al.[2022]
A single session of high-frequency rTMS (10 Hz) over the left dorsolateral prefrontal cortex significantly reduced cigarette craving in 16 nicotine-dependent participants, demonstrating its potential efficacy as a noninvasive treatment.
The reduction in craving was notably greater with real rTMS compared to sham treatment, suggesting that rTMS may be a promising tool for aiding smoking cessation efforts.
Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving.Li, X., Hartwell, KJ., Owens, M., et al.[2022]
In a study of 37 smokers with severe nicotine dependence, combining 1-Hz repetitive Transcranial Magnetic Stimulation (rTMS) with Nicotine Replacement Therapy (NRT) significantly increased abstinence rates, with 16 out of 18 participants in the active rTMS group remaining abstinent compared to 9 out of 19 in the sham group.
Active rTMS also led to a significant reduction in craving levels, particularly in the compulsive aspect of cravings, suggesting that rTMS may help manage withdrawal symptoms during smoking cessation, although the effects did not persist long-term.
Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial.Trojak, B., Meille, V., Achab, S., et al.[2018]

References

Repeated high-frequency transcranial magnetic stimulation over the dorsolateral prefrontal cortex reduces cigarette craving and consumption. [2022]
Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. [2022]
Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. [2018]
Repetitive Transcranial Magnetic Stimulation for Tobacco Treatment in Cancer Patients: A Preliminary Report of a One-Week Treatment. [2022]
Reduced executive and reward connectivity is associated with smoking cessation response to repetitive transcranial magnetic stimulation: A double-blind, randomized, sham-controlled trial. [2023]
Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. [2021]
Dosing parameters for the effects of high-frequency transcranial magnetic stimulation on smoking cessation: study protocol for a randomized factorial sham-controlled clinical trial. [2021]
Left frontal pole repetitive transcranial magnetic stimulation reduces cigarette cue-reactivity in correlation with verbal memory performance. [2022]
A double-blind randomized clinical trial of high frequency rTMS over the DLPFC on nicotine dependence, anxiety and depression. [2021]
Transcranial Magnetic Stimulation for Long-Term Smoking Cessation: Preliminary Examination of Delay Discounting as a Therapeutic Target and the Effects of Intensity and Duration. [2022]