rTMS for Smoking Addiction

Overseen By Sarah A Jackson, BA MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Bupropion, Varenicline, others

Disqualifiers: Substance use, Neurological disorders, others

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

Compensation: Varies

Number of Visits: 15

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best way to use a brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) to help Veterans quit smoking. Researchers will compare two rTMS methods: standard TMS and a new precision TMS. The goal is to identify which method more effectively reduces cigarette use. Veterans who smoke 10 or more cigarettes a day and are motivated to quit may be suitable candidates for this trial. As an unphased trial, it offers Veterans the chance to contribute to innovative research that could lead to more effective smoking cessation methods.

Will I have to stop taking my current medications?

If you are currently using nicotine patches, electronic cigarettes, or are prescribed bupropion or varenicline, you will need to stop these before participating in the trial.

What prior data suggests that this protocol is safe for smoking cessation?

Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) is safe for helping people quit smoking. Research generally finds that rTMS is well-tolerated, even among sensitive groups like cancer patients. In one study, a participant reported back pain after a placebo treatment, but this was not linked to the actual rTMS, and the person recovered.

Studies suggest that both deep rTMS and precision TMS are safe options. These treatments involve non-invasive brain stimulation, meaning they don't require surgery or medication, which reduces the risk of serious side effects. Most participants in these studies did not experience significant negative effects.

Overall, rTMS is considered safe for helping people quit smoking. The FDA has already approved it for this purpose, indicating a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for smoking addiction, like nicotine replacement therapy and medications such as varenicline or bupropion, aim to reduce cravings and withdrawal symptoms. However, rTMS (repetitive transcranial magnetic stimulation) offers a unique non-invasive approach by directly targeting brain regions involved in addiction. Researchers are excited about Deep rTMS and Precision TMS because they stimulate specific brain areas with precision, potentially altering neural pathways associated with smoking addiction. Deep rTMS targets the bilateral insula and lateral prefrontal cortex, while Precision TMS uses personalized imaging to focus on the left dorsolateral prefrontal cortex. This precision could lead to more effective and faster results compared to traditional methods.

What evidence suggests that this trial's rTMS protocols could be effective for smoking cessation?

This trial compares two methods of repetitive transcranial magnetic stimulation (rTMS) for smoking addiction. Studies have shown that rTMS can reduce the urge to smoke and decrease cigarette consumption. One group in this trial will receive Deep rTMS, which has lowered cigarette use and nicotine addiction. Another group will receive Precision TMS, which uses personalized targeting and may lead to higher quit rates and reduced smoking. Both treatments are non-invasive and FDA-approved for treating tobacco use disorder. ^{1 2 3 4 5}

Who Is on the Research Team?

Xingbao Li, MD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

This trial is for Veterans who are struggling with tobacco use and want to quit smoking. Participants should be motivated to stop smoking and willing to undergo non-invasive brain stimulation treatments. Specific eligibility details are not provided, but typically participants must meet certain health criteria.

Inclusion Criteria

Individuals who smoke 10 or more cigarettes per day and have a CO level > 10 ppm indicative of recent smoking

Those who have not received substance abuse treatment within the previous 30 days

Those who can comply with protocol requirements and likely complete all study procedures

Exclusion Criteria

Current moderate to severe substance use of any psychoactive substances other than nicotine or caffeine, as defined by DSM-V criteria

I do not have severe heart, kidney, liver problems, or uncontrolled high blood pressure.

Contraindications to MRI (e.g., metal in the skull, orbital or intracranial cavity, or claustrophobia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rTMS treatment for smoking cessation, comparing two protocols: DTMS and precision TMS

6 weeks

15 daily sessions over 3 weeks, followed by 3 weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• rTMS

Trial Overview

The study is testing two types of repetitive transcranial magnetic stimulation (rTMS) protocols: standard TMS and precision TMS, which uses personalized imaging and electric field modeling. The goal is to determine which method is more effective at helping Veterans quit smoking.

How Is the Trial Designed?

Group I: Precision TMS Experimental Treatment 1 Intervention

The other group will receive 10 Hz personalized-image-guided and Efield-modeling dose rTMS (precision TMS) with a protocol of 5 seconds on, 10 seconds off, and a total of 3000 pulses/session, lasting 15 minutes, targeting the left DLPFC.

Group II: Deep rTMS Active Control 1 Intervention

DThe first group will receive 10 Hz DTMS (standard TMS) with a protocol of 3 seconds on, 15 seconds off, and a total of 1800 pulses/session, lasting 18 minutes, targeting the bilateral insula and lateral prefrontal cortex.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9293555/

Repetitive Transcranial Magnetic Stimulation for Tobacco ...

In general, rTMS was found to be safe for tobacco treatment with cancer patients. One participant reported back pain after sham treatment and recovered without ...

2.

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, ...

3.

mecp.springeropen.com

mecp.springeropen.com/articles/10.1186/s43045-025-00503-3

Efficacy and safety of repetitive transcranial magnetic ...

This study aimed to assess the effectiveness of active r-TMS in reducing smoking behavior, withdrawal symptoms, cravings, and nicotine dependence

4.

academic.oup.com

academic.oup.com/braincomms/article/7/2/fcaf101/8052715

Repetitive transcranial magnetic stimulation reduces smoking ...

Clinical studies have shown that high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC) effectively decreases smoking cravings ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03264313

Deep Transcranial Magnetic Stimulation (dTMS) to Induce ...

Amiaz and collegues found that 10 days of high-frequency rTMS over the DLPFC reduced cigarette consumption and nicotine dependence. In addition, the rTMS ...