TMS for Nicotine Addiction
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rutgers, The State University of New Jersey
Must not be taking: Central nervous system
Disqualifiers: Neurological disorder, Bipolar, Schizophrenia, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Our primary goal will be to identify the optimal prefrontal-cingulate target by systematically measuring the efficacy of various image-based targeting techniques to increase the reward positivity using the 10-Hz TMS protocol in dependent smokers. Our secondary objective will be to measure the targets' effectiveness to increase decision-making capacity using the probabilistic selection task (PST). Our third objective will be to specifically assess whether the TMS targets has a differential impact on state levels of craving relative to baseline (Tobacco Craving Questionnaire \[TCQ\]. We plan to accomplish these three objectives using a randomized, controlled experiment involving 3 sessions.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those on uninterruptable central nervous system medication. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of this treatment for nicotine addiction?
Research shows that repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) can reduce cigarette craving and consumption. A large study found that smokers receiving active rTMS had a higher quit rate compared to those receiving a sham treatment, indicating its potential effectiveness in helping people quit smoking.
12345Is TMS safe for humans?
TMS (Transcranial Magnetic Stimulation) is generally considered safe for humans, as it is a non-invasive method used to treat various conditions, including depression and addiction. Studies have shown that it can be safely administered, with the most common side effects being mild and temporary, such as headaches or scalp discomfort.
13467How is TMS treatment different from other treatments for nicotine addiction?
TMS (Transcranial Magnetic Stimulation) is unique because it noninvasively stimulates the brain, specifically targeting the left dorsolateral prefrontal cortex (DLPFC), to reduce nicotine cravings and increase abstinence rates. Unlike traditional treatments like nicotine replacement or medications, TMS directly influences brain activity related to addiction without the use of drugs.
138910Eligibility Criteria
This trial is for individuals aged 18-55 with nicotine addiction who are in good mental and physical health, can follow the study plan, and haven't had substance abuse treatment recently. Pregnant women or those with brain lesions, metal implants affecting MRI scans, or certain neurological conditions cannot participate.Inclusion Criteria
Not received substance abuse treatment within the previous 30 days
Be willing to provide informed consent
Nicotine dependent individuals (according to the Alcohol, Smoking and Substance Involvement Screening Test nicotine dependence score)
+5 more
Exclusion Criteria
I have a history of brain-related autoimmune, endocrine, viral, or vascular disorders.
I have never been diagnosed with bipolar disorder, schizophrenia, PTSD, dementia, or major depression.
Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia)
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Session A
Participants undergo MRI scanning and receive structural, fMRI, DWI, and resting-state FC scans
1 day
1 visit (in-person)
Sessions B and C
Participants receive rTMS at different prefrontal targets and complete T-maze and PST tasks
2 weeks
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests whether a type of brain stimulation called 10-Hz TMS aimed at the DLPFC affects reward activity in smokers. It's a controlled experiment comparing real TMS to sham (fake) treatment over three sessions to see if it helps decision-making and reduces cravings.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TMSExperimental Treatment1 Intervention
Participants in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined prefrontal target for a total of 1000 pulses. Within each of the two TMS sessions, two targets will be stimulated.
Group II: Sham TMSPlacebo Group1 Intervention
Identical parameters will be applied to the SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation.
10-Hz TMS to the DLPFC is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as rTMS for:
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
- Post-Traumatic Stress Disorder (PTSD)
🇪🇺 Approved in European Union as rTMS for:
- Major Depressive Disorder (MDD)
🇨🇦 Approved in Canada as rTMS for:
- Major Depressive Disorder (MDD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rutgers University - NewarkNewark, NJ
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Who Is Running the Clinical Trial?
Rutgers, The State University of New JerseyLead Sponsor
References
Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. [2022]Repetitive transcranial magnetic stimulation (rTMS) can noninvasively stimulate the brain and transiently amplify or block behaviors mediated through a region. We hypothesized that a single high-frequency rTMS session over the left dorsolateral prefrontal cortex (DLPFC) would reduce cue craving for cigarettes compared with a sham TMS session.
Repeated high-frequency transcranial magnetic stimulation over the dorsolateral prefrontal cortex reduces cigarette craving and consumption. [2022]To evaluate the effect of repeated high-frequency transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (DLPFC), combined with either smoking or neutral cues, on cigarette consumption, dependence and craving.
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.
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.
Effects of short-term, high-frequency repetitive transcranial magnetic stimulation to bilateral dorsolateral prefrontal cortex on smoking behavior and cognition in patients with schizophrenia and non-psychiatric controls. [2021]High rates of tobacco smoking and smoking cessation failure in schizophrenia may be related to prefrontal cortical dysfunction. Novel treatment options for tobacco use disorder are needed given the limited efficacy of current pharmacotherapies. Preliminary evidence suggests high-frequency repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsolateral prefrontal cortex (DLPFC) may suppress tobacco craving in smokers with schizophrenia. The goal of this study was to determine effects of rTMS for tobacco craving and cognition using a short-term (3-day) human laboratory paradigm.
Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis. [2020]Repetitive transcranial magnetic stimulation (rTMS) is increasingly used as an intervention for treating substance dependence. We aimed to assess evidence of the anti-craving and consumption-reducing effects of rTMS in patients with alcohol, nicotine and illicit drug dependence.
Transcranial magnetic stimulation in the treatment of substance addiction. [2022]Transcranial magnetic stimulation (TMS) is a noninvasive method of brain stimulation used to treat a variety of neuropsychiatric disorders, but is still in the early stages of study as addiction treatment. We identified 19 human studies using repetitive TMS (rTMS) to manipulate drug craving or use, which exposed a total of 316 adults to active rTMS. Nine studies involved tobacco, six alcohol, three cocaine, and one methamphetamine. The majority of studies targeted high-frequency (5-20 Hz; expected to stimulate neuronal activity) rTMS pulses to the dorsolateral prefrontal cortex. Only five studies were controlled clinical trials: two of four nicotine trials found decreased cigarette smoking; the cocaine trial found decreased cocaine use. Many aspects of optimal treatment remain unknown, including rTMS parameters, duration of treatment, relationship to cue-induced craving, and concomitant treatment. The mechanisms of rTMS potential therapeutic action in treating addictions are poorly understood, but may involve increased dopamine and glutamate function in corticomesolimbic brain circuits and modulation of neural activity in brain circuits that mediate cognitive processes relevant to addiction, such as response inhibition, selective attention, and reactivity to drug-associated cues. rTMS treatment of addiction must be considered experimental at this time, but appears to have a promising future.
Two weeks of image-guided left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation improves smoking cessation: A double-blind, sham-controlled, randomized clinical trial. [2021]Previous studies have found that repetitive transcranial magnetic stimulation (rTMS) to the left dorsal lateral prefrontal cortex (LDLPFC) transiently reduces smoking craving, decreases cigarette consumption, and increases abstinence rates.
Transcranial magnetic stimulation of the left dorsolateral prefrontal cortex decreases cue-induced nicotine craving and EEG delta power. [2022]TMS has high potential as smoking cessation treatment. However, the neural mechanisms underlying TMS induced reduction of tobacco craving remain unclear. Electroencephalographic (EEG) delta frequency has been associated with the activity of the dopaminergic brain reward system, which is crucial for nicotine induced effects, and decreases after nicotine admission in smokers.
[Transcranial magnetic stimulation for nicotine dependence]. [2014]70-80% of regular smokers fulfill the ICD-10-criteria of dependence. In Germany, approximately 120,000 deaths per year are caused by tobacco-associated diseases. In contrast, therapeutic interventions, such as nicotine substitution or bupropione, yield poor abstinence rates of 30% after 12 months, at best. In animal experiments, repetitive transcranial magnetic stimulation (rTMS) exhibited modulatory effects on dopaminergic neurotransmission in regions of the so-called reward system. This pilot study should evaluate, if rTMS could modulate subjective craving for tobacco, which quite often leads to relapse to smoking. Therefore, 11 tobacco-dependent cigarette smokers were randomly assigned to a course of verum- and placebo-rTMS on consecutive days. Craving, as measured by a visual analogue scale, is significantly decreased after Verumstimulation compared to placebo-stimulation intra-individually. This encourages further studies to clarify, if rTMS might be helpful in achieving higher tobacco abstinence rates in smokers willing to quits.