Varenicline + TMS for Nicotine Addiction
(V-TMS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining varenicline, a medication that aids in quitting nicotine, with Transcranial Magnetic Stimulation (TMS), a non-invasive treatment using magnetic fields, effectively helps adults stop using nicotine products. Researchers will compare the effects of active TMS with a sham (inactive) TMS to assess whether the active treatment better reduces cravings and increases abstinence. Individuals who have used nicotine daily for at least the past 90 days and wish to quit within the next month may be suitable for this study. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot use other smoking cessation aids during the study. It's best to discuss your current medications with the study team to ensure they don't interfere with the trial.
What is the safety track record for varenicline and Transcranial Magnetic Stimulation?
Research has shown that both varenicline and Transcranial Magnetic Stimulation (TMS) have been studied for safety in people trying to quit smoking. Varenicline, a medication generally well-tolerated, may cause nausea, trouble sleeping, or unusual dreams in some users. The FDA has approved it for smoking cessation, confirming its safety through testing.
For TMS, studies have found it is usually safe for quitting smoking, with headaches as the most common side effect. No seizures have been reported in these studies, indicating good safety. This treatment uses magnetic fields to stimulate certain brain areas and appears effective without serious problems.
Both treatments aim to help people quit smoking and have been safely used in other trials. Participants should still consult their doctor about any concerns before joining a trial.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the combination of Varenicline and Transcranial Magnetic Stimulation (TMS) for tackling nicotine addiction. Unlike traditional treatments that focus solely on medication or counseling, this approach combines the proven effectiveness of Varenicline—a medication that reduces cravings and withdrawal symptoms—with TMS, a non-invasive technique that uses magnetic fields to stimulate specific areas of the brain linked to addiction. This dual-action strategy has the potential to enhance the success rates of smoking cessation by targeting both the physiological and neurological aspects of addiction. Moreover, TMS is tailored to each individual based on their brain MRI, potentially leading to more personalized and effective treatment outcomes.
What evidence suggests that this trial's treatments could be effective for nicotine addiction?
Studies have shown that varenicline is the most effective medication for quitting smoking compared to options like nicotine patches or gum. It targets brain receptors to reduce cravings and withdrawal symptoms. In this trial, participants will receive varenicline alongside either active or sham Transcranial Magnetic Stimulation (TMS). Research indicates that TMS, a non-invasive brain treatment, can help people quit smoking by reducing nicotine cravings and the number of cigarettes smoked each day. When used together, these treatments might be even more effective at increasing quit rates and reducing cravings. Early studies found that high-frequency TMS combined with smoking cues significantly improved the chances of quitting. This combination shows promise for those looking to quit nicotine for good.678910
Who Is on the Research Team?
Jodi M Gilman, PhD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
Adults who are trying to quit using nicotine products, such as cigarettes or vaping devices, may participate. They must be willing to undergo brain MRI scans, take varenicline daily for 12 weeks, attempt quitting nicotine by the end of week two on varenicline, and attend TMS treatments and follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline assessments including questionnaires, laboratory assessments, urinalysis, fMRI scan, and receive study medication
TMS Treatment Preparation
Participants undergo TMS treatment preparation to locate treatment target and determine stimulation intensity
TMS Treatment
Participants receive 5 consecutive days of TMS treatments, 5 sessions per day
Varenicline Treatment
Participants take varenicline daily for 12 weeks, with a quit date set for the Saturday following TMS treatments
Follow-up
Participants complete weekly follow-ups to assess nicotine use, complete questionnaires, and receive nicotine cessation counseling
What Are the Treatments Tested in This Trial?
Interventions
- Transcranial Magnetic Stimulation
- Transcranial Magnetic Stimulation Sham
- Varenicline
Trial Overview
The study is testing whether combining a medication called varenicline with accelerated Transcranial Magnetic Stimulation (TMS) increases the success rate of quitting nicotine use compared to varenicline with sham TMS. Participants will receive either active or inactive TMS alongside their medication regimen.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
In this arm, participants will take 12 weeks of varenicline. They will also receive 5 consecutive days of 5 hourly TMS treatments, adjusted to an individualized target specific to the participant based on their brain MRI collected at the baseline imaging visit. Participants will also receive 6 brief nicotine cessation counseling sessions.
In this arm, participants will receive 12 weeks of varenicline and instructions on how to take it. They will also receive 5 consecutive days of 5 hourly TMS treatments, adjusted to an individualized target specific to the participant based on their brain MRI collected at the baseline imaging visit. However, the sham setting will deliver no magnetic field to the brain; instead, it will deliver electrical current to the scalp to mimic the feel of active treatment. Participants will also receive 6 brief nicotine cessation counseling sessions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Brigham and Women's Hospital
Collaborator
Citations
Repetitive transcranial magnetic stimulation for smoking ...
High-frequency stimulation (10 Hz) with exposure to smoking cues resulted in significantly higher abstinence rates at end of treatment (43.75%) ...
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 ...
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, ...
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.
5.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06346028?term=AREA%5BBasicSearch%5D(brainsway)&rank=7Implementation 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 ...
Transcranial Magnetic Stimulation Treatment for Smoking ...
Safety outcomes were consistent with prior TMS smoking cessation trials, with no reported seizures and headache as the most common adverse ...
Efficacy of insula deep repetitive transcranial magnetic ...
This study provides evidence of the potential benefit of having a combined treatment for smoking cessation using insula rTMS with the H11 coil and varenicline.
Study Details | NCT07145866 | Varenicline and ...
The goal of this clinical trial is to learn if a combination of varenicline and accelerated Transcranial Magnetic Stimulation (TMS) works to help adults ...
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
10.
tobaccopreventioncessation.com
tobaccopreventioncessation.com/Cue-restricted-smoking-increases-quit-rates-with-varenicline,133570,0,2.htmlCue restricted smoking increases quit rates with varenicline
Cue restricted smoking was associated with a substantially increased chance of quitting compared with standard advice during treatment with varenicline.
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