Transcranial Magnetic Stimulation for Smoking Addiction

Overseen by Travis E Baker, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Central nervous system

Disqualifiers: Neurological disorder, Bipolar, Schizophrenia, others

No Placebo Group

Approved in 3 Jurisdictions

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 2 3 4 7}

Research Team

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

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.

Trial 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 (Behavioural Intervention)

Trial Overview The 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

Group I: Inhibitory TMS Experimental Treatment 1 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 TMS Experimental Treatment 1 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 Canada for the following indications:

Approved in Canada as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Dr. Jonathan Holloway

Rutgers, The State University of New Jersey

Chief Executive Officer since 2020

PhD in History from Yale University

Dr. Brian Strom

Rutgers, The State University of New Jersey

Chief Medical Officer since 2014

MD from Rutgers New Jersey Medical School

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. Zangen, A., Moshe, H., Martinez, D., et al.[2021]

Transcranial magnetic stimulation (TMS) has been explored in 19 studies involving 316 adults for its potential to reduce drug cravings and use, particularly targeting the dorsolateral prefrontal cortex with high-frequency pulses.

While some studies showed promising results, such as decreased smoking and cocaine use, the treatment is still experimental, and the exact mechanisms and optimal parameters for rTMS in addiction treatment remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in the treatment of substance addiction. Gorelick, DA., Zangen, A., George, MS.[2022]

Excitatory repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral pre-frontal cortex significantly reduces craving for substances in patients with dependence, with a strong effect size (Hedges' g = -0.62) based on a meta-analysis of 26 randomized controlled trials involving 748 participants.

In addition to reducing cravings, rTMS also effectively decreases substance consumption, particularly when using excitatory stimulation protocols, indicating its potential as a therapeutic intervention for substance dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis. Zhang, JJQ., Fong, KNK., Ouyang, RG., et al.[2020]

In a study involving 42 treatment-seeking smokers, 10 sessions of repetitive transcranial magnetic stimulation (rTMS) significantly reduced daily cigarette consumption by 62.93% compared to a 39.43% reduction with sham treatment, indicating its efficacy in tobacco use disorders.

fMRI results showed that rTMS increased activity in brain areas associated with executive control (dorsal anterior cingulate cortex and DLPFC) while decreasing activity in reward-related areas (medial orbitofrontal cortex), suggesting a mechanism of action that enhances self-control and reduces craving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced executive and reward connectivity is associated with smoking cessation response to repetitive transcranial magnetic stimulation: A double-blind, randomized, sham-controlled trial. Li, X., Caulfield, KA., Hartwell, KJ., et al.[2023]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Left frontal pole repetitive transcranial magnetic stimulation reduces cigarette cue-reactivity in correlation with verbal memory performance. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in the treatment of substance addiction. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Recruitment and Retention of Smokers Versus Nonsmokers in an rTMS Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Reduced executive and reward connectivity is associated with smoking cessation response to repetitive transcranial magnetic stimulation: A double-blind, randomized, sham-controlled trial. [2023]