Transcranial Magnetic Stimulation for Smoking
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Centre for Addiction and Mental Health
Must not be taking: Anticonvulsants, Benzodiazepines
Disqualifiers: Intracranial implants, Pregnancy, Seizure history, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?Repetitive transcranial magnetic stimulation (rTMS) is an alternative non-invasive treatment to help people quit smoking. rTMS uses a magnetic field to stimulate regions of the brain that are involved in addiction. The two brain regions that are stimulated are the insula and the dorsolateral prefrontal cortex, which are involved in drug craving and decision-making, respectively.
The goal of this clinical trial is to learn more about the feasibility of offering rTMS as a treatment in the Nicotine Dependence Clinic (NDC) to help daily smokers to quit smoking. The NDC is at the Center for Addiction and Mental Health (CAMH) at 1025 Queen Street West, in Toronto, Canada.
Participants will be asked to come to CAMH to:
* Complete surveys and optional interviews to learn more about their opinions and experiences with this treatment
* Start a treatment course that includes 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks. Each session lasts about 25 minutes and is provided by an rTMS technician with medical supervision.
Objectives
• Learning about the feasibility of rTMS as a treatment option for patients in the NDC will help us improve the treatment when offering it in other clinics, which may help improve smoking quit rates and people's overall health.
Will I have to stop taking my current medications?
You might need to stop taking certain medications. If you're on anticonvulsants or benzodiazepines, you may need to taper off unless it's unsafe to do so. It's best to discuss this with your doctor.
What data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for smoking cessation?
Research shows that rTMS can help reduce tobacco cravings and increase quit rates among smokers. In a large study, smokers who received rTMS had a higher quit rate compared to those who received a fake treatment, and they also experienced a greater reduction in cigarette consumption and cravings.
12345Is transcranial magnetic stimulation (TMS) safe for humans?
Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for humans, as it has been used in various studies for smoking cessation and other conditions without significant safety concerns.
12367How does the treatment rTMS differ from other treatments for smoking cessation?
Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it is a non-invasive brain stimulation technique that targets specific brain areas involved in addiction, such as the prefrontal cortex, to reduce cravings and cigarette consumption. Unlike traditional methods like nicotine replacement therapy, rTMS directly influences brain activity and connectivity, offering a novel approach to smoking cessation.
12378Eligibility Criteria
This trial is for daily smokers who want to quit and are willing to attend treatment sessions at the Center for Addiction and Mental Health in Toronto. Participants must complete surveys and interviews, undergo 3 weeks of daily rTMS treatments followed by weekly sessions for another 3 weeks.Inclusion Criteria
Smoking cigarettes daily (self-reported)
I am currently undergoing rTMS treatment.
Health care providers currently employed as a HCP (physician, social worker, occupational therapist, etc.) at the CAMH NDC and involved in the care of at least 1 patient who has received rTMS for smoking cessation
Exclusion Criteria
I am receiving rTMS and do not have any severe health, mental, or substance use issues.
There are no exclusion criteria for HCP Participants
I am undergoing rTMS and have no removable metal in or near my head.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions
6 weeks
Daily visits for 3 weeks, then weekly visits for 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Long-term follow-up
Participants' smoking cessation rates are evaluated through self-reported and biochemically verified methods
Up to 1 year
Participant Groups
The study tests repetitive transcranial magnetic stimulation (rTMS) using Brainsway H4 deep rTMS coil and stimulator system on two brain regions linked to addiction cravings and decision-making. The aim is to assess if this non-invasive method can help smokers quit by stimulating these areas.
1Treatment groups
Experimental Treatment
Group I: Patients Receiving rTMSExperimental Treatment1 Intervention
Participants will receive 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks of treatment. Each session lasts about 25 minutes and is provided by an rTMS technician at the Temerty Center at 1025 Queen Street West, with medical supervision.
Repetitive Transcranial Magnetic Stimulation (rTMS) is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as rTMS for:
- Depression
- Smoking cessation
🇪🇺 Approved in European Union as rTMS for:
- Depression
🇨🇦 Approved in Canada as rTMS for:
- Depression
🇯🇵 Approved in Japan as rTMS for:
- Depression
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Loading ...
Who Is Running the Clinical Trial?
Centre for Addiction and Mental HealthLead Sponsor
References
Left frontal pole repetitive transcranial magnetic stimulation reduces cigarette cue-reactivity in correlation with verbal memory performance. [2022]Although left frontal pole (LFP) repetitive transcranial magnetic stimulation (rTMS) has been recently investigated for the treatment of different substance use disorders, there is no current evidence that it can effectively influence craving or clinical outcomes in smokers. A single session of 1 Hz rTMS over LFP is proposed to explore short-term effects of this protocol in tobacco use disorder.
Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. [2018]Further evidence suggests that repetitive Transcranial Magnetic Stimulation (rTMS) is an effective method to reduce tobacco craving among smokers.
Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. [2021]Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation method increasingly used to treat psychiatric disorders, primarily depression. Initial studies suggest that rTMS may help to treat addictions, but evaluation in multicenter randomized controlled trials (RCTs) is needed. We conducted a multicenter double-blind RCT in 262 chronic smokers meeting DSM-5 criteria for tobacco use disorder, who had made at least one prior failed attempt to quit, with 68% having made at least three failed attempts. They received three weeks of daily bilat-eral active or sham rTMS to the lateral prefrontal and insular cortices, followed by once weekly rTMS for three weeks. Each rTMS session was administered following a cue-induced craving procedure, and participants were monitored for a total of six weeks. Those in abstinence were monitored for additional 12 weeks. The primary outcome measure was the four-week continuous quit rate (CQR) until Week 18 in the intent-to-treat efficacy set, as determined by daily smoking diaries and verified by urine cotinine measures. The trial was registered at ClinicalTrials.gov (NCT02126124). In the intent-to-treat analysis set (N=234), the CQR until Week 18 was 19.4% following active and 8.7% following sham rTMS (X2 =5.655, p=0.017). Among completers (N=169), the CQR until Week 18 was 28.0% and 11.7%, respectively (X2 =7.219, p=0.007). The reduction in cigarette consumption and craving was significantly greater in the active than the sham group as early as two weeks into treatment. This study establishes a safe treatment protocol that promotes smoking cessation by stimulating relevant brain circuits. It represents the first large multicenter RCT of brain stimulation in addiction medicine, and has led to the first clearance by the US Food and Drug Administration for rTMS as an aid in smok-ing cessation for adults.
Repetitive transcranial magnetic stimulation reduces cigarette consumption in schizophrenia patients. [2017]High-frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) seemed to decrease tobacco consumption and craving in nicotine-dependent people without psychiatric disorder or otherwise healthy people. Even if the prevalence of cigarette smoking in schizophrenia patients is high and estimated to be between 45% and 88%, this technique has not been systematically studied in this indication in schizophrenia yet.
Dosing parameters for the effects of high-frequency transcranial magnetic stimulation on smoking cessation: study protocol for a randomized factorial sham-controlled clinical trial. [2021]Despite the considerable success of comprehensive tobacco control efforts, tobacco use remains one of the greatest preventable causes of death and disease today. Over half of all smokers in the US make quit attempts every year, but over 90% relapse within 12 months, choosing the immediate reinforcement of smoking over the long-term benefits of quitting. Conceptual and empirical evidence supports continued investigation of high frequency repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex in reducing relapse and decreasing cigarette consumption. While this evidence is compelling, an optimal dosing strategy must be determined before a long-term efficacy trial can be conducted. The goal of this study is to determine a dosing strategy for 20 Hz rTMS that will produce the best long-term abstinence outcomes with the fewest undesirable effects.
Repetitive Transcranial Magnetic Stimulation for Tobacco Treatment in Cancer Patients: A Preliminary Report of a One-Week Treatment. [2022]Smoking cessation represents a significant opportunity to improve cancer survival rates, reduces the risk of cancer treatment complications, and improves quality of life. However, about half of cancer patients who smoke continue to smoke despite the availability of several treatments. Previous studies demonstrate that repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) decreases cue craving, reduces cigarette consumption, and increases the quit rate in tobacco use disorder. We investigated whether 5 sessions of rTMS can be safely and efficaciously used for smoking cessation in cancer patients.
Reduced executive and reward connectivity is associated with smoking cessation response to repetitive transcranial magnetic stimulation: A double-blind, randomized, sham-controlled trial. [2023]Repetitive transcranial magnetic stimulation (rTMS) can reduce cue-elicited craving, decrease cigarette consumption, and increase the abstinence rate in tobacco use disorders (TUDs). We used functional magnetic resonance imaging (fMRI) to investigate the effect of 10 sessions of rTMS on cortical activity and neural networks in treatment-seeking smokers. Smoking cue exposure fMRI scans were acquired before and after the 10 sessions of active or sham rTMS (10 Hz, 3000 pulses per session) to the left dorsal lateral prefrontal cortex (DLPFC) in 42 treatment-seeking smokers (≥ 10 cigarettes per day). Brain activity and functional connectivity were compared before and after 10 sessions of rTMS. Ten sessions of rTMS significantly reduced the number of cigarettes consumed per day (62.93%) compared to sham treatment (39.43%) at the end of treatment (p = 0.027). fMRI results showed that the rTMS treatment increased brain activity in the dorsal anterior cingulate cortex (dACC) and DLPFC, but decreased brain activity in the bilateral medial orbitofrontal cortex (mOFC). The lower strength of dACC and mOFC connectivity was associated with quitting smoking (Wald score = 5.00, p = 0.025). The reduction of cigarette consumption significantly correlated with the increased brain activation in the dACC (r = 0.76, p = 0.0001). By increasing the brain activity in the dACC and prefrontal cortex and decreasing brain activity in the mOFC, 10 sessions of rTMS significantly reduced cigarette consumption and increased quit rate. Reduced drive-reward and executive control functional connectivity was associated with the smoking cessation effect from rTMS. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02401672.
Repetitive transcranial magnetic stimulation and drug addiction. [2019]Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that is now being tested for its ability to treat addiction. This review discusses current research approaches and results of studies which measured the therapeutic use of rTMS to treat tobacco, alcohol and illicit drug addiction. The research in this area is limited and therefore all studies evaluating the therapeutic use of rTMS in tobacco, alcohol or illicit drug addiction were retained including case studies through NCBI PubMed ( http://www.ncbi.nlm.nih.gov ) and manual searches. A total of eight studies were identified that examined the ability of rTMS to treat tobacco, alcohol and cocaine addiction. The results of this review indicate that rTMS is effective in reducing the level of cravings for smoking, alcohol, and cocaine when applied at high frequencies to the dorsolateral prefrontal cortex (DLPFC). Furthermore, these studies suggest that repeated sessions of high frequency rTMS over the DLPFC may be most effective in reducing the level of smoking and alcohol consumption. Although work in this area is limited, this review indicates that rTMS is a promising modality for treating drug addiction.