Repetitive Transcranial Magnetic Stimulation for Smoking

Overseen By George Kypriotakis, PHD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antidepressants, Antipsychotics, Smoking cessation

Disqualifiers: Neurological disorders, Cardiac disease, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how individual brain responses to emotional triggers affect the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in helping people quit smoking. rTMS is a non-invasive treatment that uses magnetic fields to stimulate specific brain areas. The study includes two experimental groups, each receiving a different sequence of stimulation techniques to compare their effects. Individuals who smoke at least five cigarettes a day, have a stable living situation, and can attend both virtual and in-person appointments might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially benefit from innovative treatment approaches.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including investigational drugs, medications with anti or pro-convulsive action, psychotropic medications (like antidepressants and antipsychotics), and smoking cessation medications. If you're on any of these, you may need to stop them to participate.

What prior data suggests that repetitive transcranial magnetic stimulation (rTMS) is safe for smoking cessation?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe for people trying to quit smoking. One study reviewed several clinical trials and found that rTMS did not cause serious side effects. Most participants experienced only mild issues like headaches, which resolved quickly. Another important study supported these findings, showing that rTMS was safe and helped reduce smoking. Overall, the evidence suggests that rTMS is a safe choice for those considering it as part of a program to stop smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it offers a non-invasive approach to help people stop smoking by using magnetic fields to stimulate specific parts of the brain. Most treatments for smoking cessation, like nicotine replacement therapies or medications such as varenicline and bupropion, focus on reducing withdrawal symptoms or cravings. However, rTMS targets brain regions directly involved in addiction and craving control, potentially altering brain activity linked to smoking addiction. Researchers are excited about this treatment because it could provide a new option for individuals who haven’t had success with traditional methods, offering hope for a more effective and personalized approach to quitting smoking.

What evidence suggests that repetitive transcranial magnetic stimulation might be an effective treatment for smoking?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) can reduce the urge to smoke and decrease the number of cigarettes smoked. In this trial, participants will receive rTMS in different sequences: one group will receive FP1 (cTBS) followed by F3 (iTBS), while another group will receive F3 (iTBS) followed by FP1 (cTBS). One study found that participants who received rTMS daily for six weeks experienced fewer cravings and smoked less. Another study found that targeting a specific part of the brain with rTMS reduced the desire to smoke for most participants. While results can vary, these studies suggest that rTMS could be a helpful tool for quitting smoking. ^{4 6 7 8 9}

Who Is on the Research Team?

George Kypriotakis, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 21-60 who smoke at least 5 cigarettes or similar products daily. Participants must have a stable residence, not be pregnant or lactating, and meet safety criteria for rTMS and EEG. They should agree to vape during tasks and remove any metal above the neck for procedures. Exclusions include certain medical conditions, mental health diagnoses, substance abuse treatment, other study participation, recent rTMS exposure, specific medication use in the last three months.

Inclusion Criteria

Able to follow verbal and written instructions in English and complete all aspects of the study

Have an address and telephone number where they may be reached

Subjects must report current stable residence. Stable residence is a domicile in which an individual can operate as if it were their own homestead and does not include shelters, halfway houses, treatment centers, or group homes

Exclusion Criteria

Being pregnant or lactating

Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)

Has a hairstyle not compatible with the EEG and unwilling to modify hairstyle (e.g., braids, ponytails, dreadlocks, non-removable hair extensions or wigs, etc.) to accommodate the EGG net that is required to be worn on the scalp during the experimental procedure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rTMS treatment to assess the impact of neuroaffective and neurocognitive differences on smoking behavior

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview The study tests if individual brain responses to emotional triggers affect how people who smoke respond to repetitive Transcranial Magnetic Stimulation (rTMS). It involves telehealth and in-person visits where participants will undergo rTMS while their brain activity is monitored using EEG.

How Is the Trial Designed?

Group I: FP1 (cTBS) then F3 (iTBS) Experimental Treatment 1 Intervention

Participants will be recruit using on-line, social media, radio, and print advertisements.

Group II: F3 (iTBS) then Fp1 (cTBS) Experimental Treatment 1 Intervention

Participants will be recruit using on-line, social media, radio, and print advertisements.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10890232/

Repetitive transcranial magnetic stimulation for smoking ... A repetitive transcranial magnetic stimulation (rTMS) device with a novel coil design (H-coil) was approved for smoking cessation by the US Food and Drug ...

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772392523000202

Brain stimulation therapeutics Most studies (12/14) reported that prefrontal rTMS reduced cue craving, 7 studies showed that it decreased cigarette consumption, and 4/5 reported that multiple ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06346028?term=AREA%5BBasicSearch%5D(brainsway)&rank=7

Implementation of Transcranial Magnetic Stimulation for ... A landmark 2021 study showed that daily rTMS treatment for 6 weeks targeting these regions is effective at reducing craving and cigarette use. This study's ...

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

Efficacy of repetitive transcranial magnetic stimulation for ... Conclusion. rTMS shows promising potential as an adjunctive treatment for smoking cessation by reducing nicotine dependence (to some extent) and ...

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

Effectiveness and safety of repeated transcranial magnetic ... In this study, we conducted a meta-analysis of the effectiveness and safety of rTMS for smoking cessation based on included RCTs.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8429333/

Repetitive transcranial magnetic stimulation for smoking ... Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double‐blind randomized controlled trial

8. 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

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

Repetitive transcranial magnetic stimulation reduces smoking ... This study aimed to examine the effectiveness of rTMS in smoking cessation and to explore the underlying neural mechanism of the treatment effect.