TMS for Smoking Cessation in Schizophrenia

Recruiting at 1 trial location

Overseen By Victoria Acosta

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Cephalosporins, Antiarrhythmics

Disqualifiers: Epilepsy, Alcohol, Major medical illnesses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses a magnetic pulse device to help people with schizophrenia stop smoking. It targets specific brain areas involved in both conditions. The goal is to see if this method is effective for this particular group. This method has been shown to decrease cigarette consumption in schizophrenia patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking more than 400 mg of clozapine per day, you may not be eligible to participate.

Is TMS safe for smoking cessation in people with schizophrenia?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for humans, including those with schizophrenia and other conditions. Studies have used rTMS to help reduce cigarette cravings and consumption, and it has been safely administered in various clinical trials. ^{1 2 3 4 5}

How does the TMS treatment for smoking cessation in schizophrenia differ from other treatments?

The TMS treatment for smoking cessation in schizophrenia is unique because it uses repetitive transcranial magnetic stimulation (rTMS), a non-invasive method that targets specific brain areas involved in craving and addiction, unlike traditional pharmacotherapies. This approach has shown promise in reducing tobacco cravings and consumption by stimulating the brain's prefrontal cortex, which is often dysfunctional in schizophrenia patients. ^{1 2 3 5 6}

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

Research shows that repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation method, can reduce tobacco craving and consumption in smokers, including those with schizophrenia. A large study found that rTMS significantly increased the quit rate compared to a placebo, suggesting it may help people with schizophrenia quit smoking. ^{1 2 3 7 8}

Who Is on the Research Team?

Xiaoming Du, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 who smoke at least 5 cigarettes daily for the past year, have schizophrenia spectrum disorder, and can consent to participate. Excluded are those with certain metal implants, severe head injuries, pregnancy or unprotected sex without birth control recently, active suicidal thoughts or behaviors, recent substance abuse (except nicotine/marijuana), specific medication dosages or medical conditions affecting brain function.

Inclusion Criteria

I am between 22 and 65 years old.

Ability to give written informed consent

Smoking in the last one year or more and average cigarette per day ≥ 5 in the past 4 weeks

Exclusion Criteria

Lives 30+ miles from UTHealth Houston

I have a condition that increases my risk of seizures.

I have had a head injury with unconsciousness for over 10 minutes or brain surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active rTMS from F8 coil or H coil for smoking cessation

4 weeks

Weekly visits for rTMS sessions

Follow-up

Participants are monitored for changes in smoking behavior and brain connectivity

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Circuitry-Guided Smoking Cessation in Schizophrenia
• rTMS with F8-coil
• rTMS with H-coil

Trial Overview The study tests two types of rTMS treatments using F8-coil and H-coil on patients with schizophrenia for smoking cessation. It measures changes in smoking behavior and brain connectivity before treatment, during different stages of rTMS therapy, and at follow-up sessions.

How Is the Trial Designed?

Group I: Study group Experimental Treatment 1 Intervention

Participants in this group will receive active F8-coil delivered rTMS.

Group II: Active control group Active Control 1 Intervention

Participants in this group will receive active H-coil delivered rTMS.

Circuitry-Guided Smoking Cessation in Schizophrenia is already approved in United States for the following indications:

Approved in United States as rTMS for:

• Smoking cessation

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study involving 35 male schizophrenia patients, high-frequency rTMS (10Hz) over the left dorsolateral prefrontal cortex significantly reduced cigarette consumption compared to a sham treatment, with effects observed as early as the first week of stimulation.

The treatment did not correlate with changes in negative or depressive symptoms of schizophrenia, suggesting that rTMS specifically targets smoking behavior rather than overall psychiatric symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation reduces cigarette consumption in schizophrenia patients. Prikryl, R., Ustohal, L., Kucerova, HP., et al.[2017]

A single session of high-frequency rTMS (10 Hz) over the left dorsolateral prefrontal cortex significantly reduced cigarette craving in 16 nicotine-dependent participants, demonstrating its potential efficacy as a noninvasive treatment.

The reduction in craving was notably greater with real rTMS compared to sham treatment, suggesting that rTMS may be a promising tool for aiding smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. Li, X., Hartwell, KJ., Owens, M., et al.[2022]

A multicenter double-blind RCT involving 262 chronic smokers showed that repetitive transcranial magnetic stimulation (rTMS) significantly increased the continuous quit rate (CQR) to 19.4% compared to 8.7% for the sham treatment, indicating its efficacy in promoting smoking cessation.

This study established a safe treatment protocol for rTMS, which has now received FDA clearance as an aid for smoking cessation, marking a significant advancement in addiction medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. Zangen, A., Moshe, H., Martinez, D., et al.[2021]

In a study involving 13 smokers with schizophrenia and 14 non-psychiatric controls, high-frequency repetitive transcranial magnetic stimulation (rTMS) did not significantly reduce tobacco craving or improve cognitive function after a short-term treatment period.

Despite the lack of efficacy in modifying craving and cognitive outcomes, the study found that rTMS was safe, with no significant adverse events reported, suggesting that further long-term studies are needed to explore its potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kozak, K., Sharif-Razi, M., Morozova, M., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. Trojak, B., Meille, V., Achab, S., et al.[2018]

Repetitive Transcranial Magnetic Stimulation (rTMS) is generally safe and feasible for patients with neuropsychiatric disorders who also have a history of substance use, based on a review of 274 articles.

However, the impact of different levels of substance use on the safety and efficacy of rTMS remains unclear, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing substance use in patients receiving therapeutic repetitive transcranial magnetic stimulation: A scoping review. Tang, VM., Ibrahim, C., Rodak, T., et al.[2023]

In a study involving 11 cancer patients who smoke, 5 sessions of repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex showed modest reductions in cigarette consumption and significant decreases in craving, indicating potential efficacy for smoking cessation.

No serious side effects were reported from the rTMS treatment, suggesting it is a safe option for cancer patients seeking to quit smoking, although more research is needed to confirm its effectiveness and safety in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation for Tobacco Treatment in Cancer Patients: A Preliminary Report of a One-Week Treatment. Li, X., Toll, BA., Carpenter, MJ., et al.[2022]

High-frequency repetitive TMS (hf rTMS) applied to the left dorsolateral prefrontal cortex significantly reduces nicotine craving in smokers who have abstained for 6 hours, indicating its potential as a smoking cessation treatment.

The study found that hf rTMS also led to a decrease in EEG delta power, which is associated with the brain's reward system, suggesting that the craving reduction may be linked to changes in dopaminergic activity, although the craving and delta power changes did not directly correlate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation of the left dorsolateral prefrontal cortex decreases cue-induced nicotine craving and EEG delta power. Pripfl, J., Tomova, L., Riecansky, I., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation reduces cigarette consumption in schizophrenia patients. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Managing substance use in patients receiving therapeutic repetitive transcranial magnetic stimulation: A scoping review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation for Tobacco Treatment in Cancer Patients: A Preliminary Report of a One-Week Treatment. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation of the left dorsolateral prefrontal cortex decreases cue-induced nicotine craving and EEG delta power. [2022]