Transcranial Magnetic Stimulation for Smoking Addiction

Overseen By Emily Zhang

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Central nervous system

Disqualifiers: Neurological disorder, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 month

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Transcranial Magnetic Stimulation (TMS) to assist individuals addicted to smoking. The main goal is to determine the most effective way to use TMS to alter brain activity related to reward and decision-making in smokers. Participants will receive either excitatory or inhibitory TMS to assess its impact on cravings and decision-making. The trial seeks individuals dependent on nicotine who have not received substance abuse treatment in the last 30 days and are in stable health. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on smoking addiction treatment.

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 prior data suggests that Transcranial Magnetic Stimulation is safe for smoking addiction?

Studies have shown that transcranial magnetic stimulation (TMS) is generally safe for people trying to quit smoking. Research on excitatory TMS, which uses fast pulses, indicates that it can help reduce cigarette cravings and dependence without major side effects. For example, one study found that repeated TMS sessions lowered cigarette use and improved symptoms like anxiety, which often occur when quitting.

Researchers are also studying inhibitory TMS, which uses a different pulse pattern. Although there isn't much research on its use for smoking, its safety is supported by its application in other conditions. The most common side effects for both types of TMS are mild and might include headaches or scalp discomfort.

Overall, TMS is well-tolerated, and any side effects are usually minor and temporary. This makes TMS a promising option for those looking to quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Transcranial Magnetic Stimulation (TMS) for smoking addiction because it offers a non-invasive approach that directly targets brain activity. Unlike nicotine replacement therapies or medications like varenicline and bupropion, TMS modulates neural circuits involved in addiction through magnetic pulses, potentially reducing cravings without the need for pharmaceuticals. The trial explores different TMS protocols: Excitatory TMS aims to enhance brain activity with high-frequency stimulation, while Inhibitory TMS seeks to dampen it with a burst-firing pattern. This versatile application could provide tailored treatment options that adjust brain function to help curb smoking addiction.

What evidence suggests that Transcranial Magnetic Stimulation is effective for smoking addiction?

This trial will compare two types of Transcranial Magnetic Stimulation (TMS) for smoking addiction: Excitatory TMS and Inhibitory TMS. Studies have shown that TMS can assist individuals who want to quit smoking. Research indicates that repetitive TMS (rTMS), part of the Excitatory TMS arm in this trial, can reduce the number of cigarettes smoked daily and increase quitting success. One study found that frequent sessions of high-frequency rTMS over several days led to reduced cravings and smoking. Additionally, studies suggest that Inhibitory TMS, another treatment arm in this trial, can also decrease cravings and aid in decision-making. Overall, both types of TMS show promise in reducing nicotine dependence and cravings for smokers. ^{1 2 3 4 6}

Who Is on the Research Team?

Travis E Baker, PhD

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

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.

How Is the Trial Designed?

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 United States, Canada, European Union for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder
• Obsessive Compulsive Disorder

Approved in Canada as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Approved in European Union 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+

Published Research Related to This Trial

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]

Nonsmokers were significantly more likely to remain eligible for an rTMS study and complete it compared to smokers, with eligibility rates of 84.2% versus 57.4% and completion rates of 87.5% versus 59.3%.

The study suggests that smokers may require more careful screening for drug use and brain abnormalities before receiving rTMS treatment, highlighting a potential need for increased awareness of incidental MRI findings in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment and Retention of Smokers Versus Nonsmokers in an rTMS Study. Sheffer, CE., Brackman, S., Mennemeier, M., et al.[2023]

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. Trojak, B., Meille, V., Achab, S., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163834325001070

Effectiveness and safety of repeated transcranial magnetic ... The meta-analysis showed that, comparing with the control group, active rTMS significantly decreased the average daily number of cigarettes smoked (MD = −6.72, ...

2. mecp.springeropen.com mecp.springeropen.com/articles/10.1186/s43045-025-00558-2

Efficacy of repetitive transcranial magnetic stimulation for ... rTMS demonstrated notable potential in enhancing abstinence rates and possibly in reducing nicotine dependence with smoking cue. These effects, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10377606/

Transcranial Magnetic Stimulation as a Tool to Promote ... In one study, 13 active TMS sessions with H4 (20 min/weekday for three weeks) led to a higher one-month quit rate and reduced cigarette ...

4. nature.com nature.com/articles/s41598-020-80927-5

A double-blind randomized clinical trial of high frequency ... Our findings revealed that HF-rTMS over L-DLPCF for 10 days reduced cigarette consumption, craving, dependence, and improved associated symptoms of anxiety and ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.892075/full

Accelerated Intermittent Theta Burst Stimulation in Smoking ... These results are consistent with previous TMS trials, which show that rTMS can significantly reduce cigarette consumption and nicotine craving (21, 24, 26).

6. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2834609

Symptom Provocation and Clinical Response to ... Results of this systematic review and meta-analysis suggest that symptom provocation may enhance clinical response to TMS for OCD and nicotine dependence.