50 Participants Needed

TMS for Smoking Cessation in Schizophrenia

Recruiting at 1 trial location
DD
XD
KT
VA
Overseen ByVictoria Acosta
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12356

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.12378

Who Is on the Research Team?

XD

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
See 7 more

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.
See 9 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Study groupExperimental Treatment1 Intervention
Group II: Active control groupActive Control1 Intervention

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

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Approved in United States as rTMS for:

Find a Clinic Near You

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

Citations

Repetitive transcranial magnetic stimulation reduces cigarette consumption in schizophrenia patients. [2017]
Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. [2022]
Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. [2021]
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]
Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. [2018]
Managing substance use in patients receiving therapeutic repetitive transcranial magnetic stimulation: A scoping review. [2023]
Repetitive Transcranial Magnetic Stimulation for Tobacco Treatment in Cancer Patients: A Preliminary Report of a One-Week Treatment. [2022]
Transcranial magnetic stimulation of the left dorsolateral prefrontal cortex decreases cue-induced nicotine craving and EEG delta power. [2022]
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