50 Participants Needed

TMS + Counseling + Nicotine Replacement for Smoking Cessation

(TMS-STOP Trial)

JR
AC
Overseen ByAngela C Kirby, MS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: VA Office of Research and Development
Must be taking: Nicotine replacement
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

Tobacco use is the number one preventable cause of the death in the United States, and is high among US Veterans, and those who have experienced trauma are more likely to smoke. Despite the efficacy of current evidence-based treatments for smoking cessation, there is a critical need for alternative treatments. This project seeks to evaluate the feasibility and effectiveness of a smoking cessation treatment for Veterans with posttraumatic stress disorder (PTSD) who smoke. The treatment combines smoking cessation counseling, nicotine replacement therapy (e.g., nicotine gum), and repetitive transcranial magnetic stimulation (rTMS). rTMS is a noninvasive brain stimulation treatment that has been cleared by the Food and Drug Administration for smoking cessation in adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not be currently prescribed bupropion or varenicline. You also need to have been stable on any psychotropic medications for at least three months.

What data supports the effectiveness of this treatment for smoking cessation?

Research shows that repetitive Transcranial Magnetic Stimulation (rTMS), when combined with Nicotine Replacement Therapy (NRT), can significantly reduce tobacco cravings and increase quit rates among smokers. In a large study, smokers receiving active rTMS had higher quit rates compared to those receiving a placebo, suggesting that rTMS can be a helpful tool in smoking cessation.12345

Is the combination of TMS, counseling, and nicotine replacement safe for smoking cessation?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe and has been used in treating psychiatric disorders like depression. A large study confirmed its safety for smoking cessation, leading to FDA clearance for this use.12345

How is the TMS + Counseling + Nicotine Replacement treatment for smoking cessation different from other treatments?

This treatment is unique because it combines repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation technique, with counseling and nicotine replacement therapy. rTMS targets brain areas involved in addiction and craving, potentially enhancing the effectiveness of traditional smoking cessation methods.12345

Research Team

JR

Jonathan R Young, MD

Principal Investigator

Durham VA Medical Center, Durham, NC

Eligibility Criteria

This trial is for US Veterans aged 18-75 who smoke at least 10 cigarettes daily, have PTSD, and are stable on psychotropic meds. They must speak English and be willing to try quitting smoking. Excluded are those with brain lesions, recent substance abuse (other than tobacco), heart attack risks, seizure history, certain implanted devices or metals in the head, pregnancy, inability to consent or complete procedures.

Inclusion Criteria

I am between 18 and 75 years old.
Is a US Veteran
Meets DSM-5 criteria for tobacco use disorder
See 6 more

Exclusion Criteria

Implanted devices that may be affected by MRI or TMS (pacemaker, medication pump, cochlear implant, implanted deep brain stimulator)
I or someone in my family has had seizures or epilepsy.
I have a history of brain conditions that could increase my risk of seizures.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Neuroimaging

Participants undergo resting-state functional magnetic resonance imaging (rs-fMRI) before the rTMS treatment

1 week
1 visit (in-person)

Treatment

Participants receive a 5-day course of neuronavigated rTMS in conjunction with nicotine replacement therapy (NRT) and cognitive behavioral therapy (CBT)

1 week
5 visits (in-person)

Post-Treatment Neuroimaging

Participants undergo post-treatment rs-fMRI to assess changes in functional network connectivity

1 week
1 visit (in-person)

Follow-up

Participants are monitored for smoking cessation outcomes and safety, including self-reported cravings and withdrawal symptoms

5 weeks
2 visits (in-person)

3-Month Follow-up

Participants are assessed for long-term smoking cessation outcomes and retention

3 months
1 visit (in-person)

Treatment Details

Interventions

  • Cognitive Behavioral Therapy for Smoking Cessation
  • Nicotine Replacement Therapy
  • Repetitive Transcranial Magnetic Stimulation (rTMS)
Trial OverviewThe study tests if combining counseling for smoking cessation with nicotine replacement therapy (like nicotine gum) and repetitive transcranial magnetic stimulation (rTMS)—a noninvasive brain treatment—helps veterans quit smoking more effectively than current methods.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: active rTMSExperimental Treatment3 Interventions
Participants assigned to this group will receive active repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment.
Group II: sham rTMSPlacebo Group3 Interventions
Participants assigned to this group will receive sham repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment.

Cognitive Behavioral Therapy for Smoking Cessation is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Cognitive Behavioral Therapy for Smoking Cessation for:
  • Smoking cessation
🇪🇺
Approved in European Union as Cognitive Behavioral Therapy for Smoking Cessation for:
  • Smoking cessation

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Findings from Research

In a pilot study involving 11 tobacco-dependent smokers, repetitive transcranial magnetic stimulation (rTMS) significantly reduced cravings for tobacco compared to placebo, suggesting its potential as a therapeutic intervention.
Given that traditional smoking cessation methods have low long-term success rates, rTMS may offer a new approach to help increase abstinence rates among smokers who want to quit.
[Repetitiv Transcranial Magnetic Stimulation in Nicotine Dependence]Johann, M., Wiegand, R., Kharraz, A., et al.[2019]
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]
A pilot study involving 11 tobacco-dependent smokers found that repetitive transcranial magnetic stimulation (rTMS) significantly reduced cravings for tobacco compared to a placebo, suggesting its potential as a therapeutic intervention.
Given that traditional smoking cessation methods have low success rates (around 30% abstinence after 12 months), rTMS may offer a promising alternative to help increase tobacco abstinence rates in smokers looking to quit.
[Transcranial magnetic stimulation for nicotine dependence].Johann, M., Wiegand, R., Kharraz, A., et al.[2014]

References

[Repetitiv Transcranial Magnetic Stimulation in Nicotine Dependence] [2019]
Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. [2018]
[Transcranial magnetic stimulation for nicotine dependence]. [2014]
Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. [2021]
Transcranial Magnetic Stimulation for Long-Term Smoking Cessation: Preliminary Examination of Delay Discounting as a Therapeutic Target and the Effects of Intensity and Duration. [2022]