42 Participants Needed

Transcranial Magnetic Stimulation for Smoking Addiction

TE
EZ
Overseen ByEmily Zhang
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Our primary goal will be to identify the optimal pulse protocol by systematically measuring the efficacy of various theta burst stimulation and repetitive rTMS protocols to increase and decrease the reward positivity in dependent smokers. Our secondary objective will be to measure the protocols' effectiveness to increase decision-making capacity using the probabilistic selection task (PST). Our third objective will be to specifically assess whether the TMS targets has a differential impact on state levels of craving relative to baseline (Tobacco Craving Questionnaire \[TCQ\]. We plan to accomplish these three objectives using a randomized, controlled experiment involving 2 sessions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on uninterruptable central nervous system medication. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation for smoking addiction?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can help people quit smoking. In a large study, 19.4% of smokers who received active rTMS stopped smoking for four weeks, compared to 8.7% who received a fake treatment. This suggests rTMS may be a promising way to help people quit smoking.12345

Is transcranial magnetic stimulation (TMS) safe for humans?

Transcranial magnetic stimulation (TMS), including repetitive TMS (rTMS), is generally considered safe for humans. Studies have shown it to be a safe treatment protocol for smoking cessation, with no major safety concerns reported in large trials.12367

How does the treatment Transcranial Magnetic Stimulation (rTMS) for smoking addiction differ from other treatments?

Transcranial Magnetic Stimulation (rTMS) is unique because it is a non-invasive brain stimulation method that targets specific brain areas involved in addiction, unlike traditional treatments that often involve medication or behavioral therapy. It works by stimulating brain circuits to reduce cravings and cigarette consumption, offering a novel approach for those who have struggled to quit smoking with other methods.12347

Research Team

TE

Travis E Baker, PhD

Principal Investigator

Rutgers University

Eligibility Criteria

This trial is for individuals who are struggling with tobacco use disorder or smoking addiction. Participants should be dependent smokers to qualify.

Inclusion Criteria

No evidence of focal or diffuse brain lesion on MRI
Be willing to provide informed consent
Be able to comply with protocol requirements and likely to complete all study procedures
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Exclusion Criteria

Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia)
I have a neurological disorder that affects my brain or physical abilities.
I have never been diagnosed with bipolar disorder, schizophrenia, PTSD, dementia, or major depression.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two experimental sessions involving TMS protocols to modulate reward activity and decision-making capacity

1 month
2 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Transcranial Magnetic Stimulation
Trial OverviewThe study aims to find the best Transcranial Magnetic Stimulation (TMS) pulse protocol that can influence reward activity in the brain, potentially helping with decision-making and reducing cravings in smokers.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Inhibitory TMSExperimental Treatment1 Intervention
For condition 1b, 600 or 1200 pulses of iTBS. iTBS will be administered at 80% of each participant's RMT in a burst-firing pattern (3 pulses at 50 Hz) for a 2 s train, followed by an 8 s period of rest. Across sessions, participants will receive one of two iTBS protocols (randomized): 600 pulses (190 s) or 1200 pulses (570 s).
Group II: Excitatory TMSExperimental Treatment1 Intervention
For condition 1a, 3600 pulses of 10-Hz TMS or 3600 pulses of cTBS. 10 Hz rTMS (110% RMT stimulation intensity; 10 Hz frequency; 5 s on and 26 s off; 3600 pulses per session; total duration of 40 min). cTBS (80% RMT, (3 pulses at 50 Hz with a repeated frequency of 5 Hz, 200 ms intervals, containing 1800 pulses, 60 second break, 1800 pulses; total duration of 5 minutes).

Transcranial Magnetic Stimulation is already approved in United States, Canada, European Union for the following indications:

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Approved in United States as Transcranial Magnetic Stimulation for:
  • Major Depressive Disorder
  • Obsessive Compulsive Disorder
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Approved in Canada as Transcranial Magnetic Stimulation for:
  • Major Depressive Disorder
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Approved in European Union as Transcranial Magnetic Stimulation for:
  • Major Depressive Disorder

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

Findings from Research

A pilot study involving 24 participants with severe nicotine dependence showed that 1 Hz repetitive transcranial magnetic stimulation (rTMS) over the left frontal pole significantly reduced craving responses to both smoking-related and neutral cues, indicating its potential efficacy in treating tobacco use disorder.
The study found a correlation between improved verbal memory recall and reduced reactivity to neutral cues, suggesting that rTMS may influence craving experiences through its effects on memory systems.
Left frontal pole repetitive transcranial magnetic stimulation reduces cigarette cue-reactivity in correlation with verbal memory performance.Marques, RC., Marques, D., Vieira, L., et al.[2022]
A multicenter double-blind RCT involving 262 chronic smokers showed that repetitive transcranial magnetic stimulation (rTMS) significantly increased the continuous quit rate (CQR) to 19.4% compared to 8.7% for the sham treatment, indicating its efficacy in promoting smoking cessation.
This study established a safe treatment protocol for rTMS, which has now received FDA clearance as an aid for smoking cessation, marking a significant advancement in addiction medicine.
Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial.Zangen, A., Moshe, H., Martinez, D., et al.[2021]
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

Left frontal pole repetitive transcranial magnetic stimulation reduces cigarette cue-reactivity in correlation with verbal memory performance. [2022]
Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. [2021]
Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. [2018]
Transcranial magnetic stimulation in the treatment of substance addiction. [2022]
Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis. [2020]
Recruitment and Retention of Smokers Versus Nonsmokers in an rTMS Study. [2023]
Reduced executive and reward connectivity is associated with smoking cessation response to repetitive transcranial magnetic stimulation: A double-blind, randomized, sham-controlled trial. [2023]