Accelerated dTMS for Smoking Cessation

Not yet recruiting at 1 trial location
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FT
Overseen ByFlorence Tang, MA
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Waypoint Centre for Mental Health Care
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called accelerated deep transcranial magnetic stimulation (aTMS) to help people quit smoking. The goal is to determine if a short, one-week course of this treatment is both feasible and effective in reducing cigarette use and cravings. Suitable candidates for this trial should have struggled with tobacco use for some time and be motivated to quit smoking soon. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you do not use other smoking cessation aids and avoid medications that lower the seizure threshold, like clozapine, or more than 2 mg of lorazepam (or an equivalent) or any anticonvulsants.

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

Research has shown that repetitive transcranial magnetic stimulation (rTMS), a treatment similar to the one tested in this trial, is generally safe for helping people quit smoking. A study reviewing multiple trials found that participants tolerated rTMS well. Most side effects are mild, such as headaches or slight discomfort at the stimulation site, and these usually resolve quickly.

Another study examined a type of rTMS called accelerated intermittent theta burst stimulation, similar to the treatment in this trial. It found that participants tolerated the treatment, with no serious side effects reported. This suggests that the accelerated deep transcranial magnetic stimulation (aTMS) tested in this trial might also be safe.

Since this trial is in an early phase, the main focus is on ensuring the treatment's safety and managing any side effects. This step is crucial before a treatment can be considered effective or approved for widespread use.12345

Why do researchers think this study treatment might be promising for smoking cessation?

Unlike the standard smoking cessation treatments, which often involve nicotine replacement therapies or medications like varenicline, accelerated dTMS uses magnetic pulses to target specific brain areas, namely the insula and prefrontal cortex. This method aims to reduce cravings and withdrawal symptoms by directly influencing brain activity, which is a novel approach compared to conventional treatments. Researchers are excited about accelerated dTMS because it offers a non-invasive option that could potentially work faster and with fewer side effects than traditional medication-based therapies.

What evidence suggests that accelerated dTMS is effective for smoking cessation?

Studies have shown that repetitive transcranial magnetic stimulation (rTMS) holds promise for helping people quit smoking. Research indicates that it can significantly reduce cigarette use and nicotine cravings. One key study found that deep TMS effectively aids smoking cessation. Additionally, a three-week course of deep TMS resulted in higher quit rates, particularly among younger and more educated individuals. Overall, the evidence is encouraging for using accelerated deep TMS, the focus of this trial, as a treatment to help people quit smoking.56789

Who Is on the Research Team?

BL

Bernard Le Foll, MD, PhD, MCFP (AM) FCAHS

Principal Investigator

Waypoint Centre for Mental Health Care

Are You a Good Fit for This Trial?

Adults aged 18-65 with Tobacco Use Disorder who want to quit smoking may participate. The trial is testing a non-drug treatment over a short period. Participants must be able to attend multiple sessions for one week and commit to follow-up assessments.

Inclusion Criteria

Must sign and date the informed consent form
Stated willingness to comply with all study procedures
Able to communicate in English
See 4 more

Exclusion Criteria

Pregnancy, trying to become pregnant or breastfeeding
Reported smoking abstinence in the 3 months preceding screening visit
Contraindication to rTMS
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive bilateral accelerated deep transcranial magnetic stimulation (aTMS) for smoking cessation, with 4 sessions per day for 5 days

1 week
20 visits (in-person)

Follow-up

Participants are monitored for smoking outcomes, including abstinence and craving, at various intervals post-treatment

26 weeks
Multiple follow-up visits at weeks 3, 5, 9, 13, and 26

What Are the Treatments Tested in This Trial?

Interventions

  • Accelerated dTMS

Trial Overview

The study is testing whether five days of bilateral deep accelerated transcranial magnetic stimulation (aTMS), with four daily sessions, can help people stop smoking. It will measure if the treatment is easy to stick with, tolerable, and effective at reducing or stopping tobacco use.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Accelerated Repetitive Transcranial Magnetic StimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Waypoint Centre for Mental Health Care

Lead Sponsor

Citations

Efficacy of repetitive transcranial magnetic stimulation for ...

rTMS shows promising potential as an adjunctive treatment for smoking cessation by reducing nicotine dependence (to some extent) and improving ...

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).

Repetitive transcranial magnetic stimulation for smoking ...

The level of evidence is now very promising for the efficacy of dTMS in smoking cessation after a pivotal RCT demonstrating clinical effectiveness (Zangen et al ...

Accelerated Deep Transcranial Magnetic Stimulation for ...

Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. World Psychiatry 2021;20 ...

Moderators of the Response to Deep TMS for Smoking ...

The results indicate that a three-week course of Deep TMS yields a higher smoking addiction quit rate among younger, more educated, Caucasian individuals with ...

NCT07292883 | Accelerated dTMS Smoking Cessation

The goal of this clinical trial is to examine whether a 5-day course of bilateral accelerated deep transcranial magnetic stimulation (aTMS) ...

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.

Transcranial Magnetic Stimulation for Long-Term Smoking ...

Repetitive transcranial magnetic stimulation (rTMS) is a novel treatment for smoking cessation and delay discounting rate is novel therapeutic target.

Accelerated rTMS for the Reduction of Nicotine Craving

The purpose if this study is to determine if five treatments of repetitive transcranial magnetic stimulation (rTMS) can reduce craving for cigarettes in smokers ...