Using deep rTMS to help reduce smoking in people with schizophrenia

Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia

This study is testing if a special brain treatment can help people with schizophrenia reduce their smoking by looking at changes in their brain's connections.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Stony Brook University (other)
• Locations: 1 site (Stony Brook, New York)
• Trial ID: NCT05724810 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of deep repetitive transcranial magnetic stimulation (dTMS) on synaptic density in the insula region of the brain, using positron emission tomography (PET) and the radiotracer [11C]UCB-J. The goal is to understand how changes in brain plasticity relate to smoking behavior in patients diagnosed with schizophrenia. By comparing active dTMS to sham dTMS, the study aims to provide insights into new therapeutic approaches for smoking cessation in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with a diagnosis of schizophrenia or related disorders who are daily smokers and wish to quit.

Not a fit: Patients with significant psychopathology unrelated to schizophrenia or those currently using smoking cessation medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to innovative treatments for smoking cessation specifically tailored for individuals with schizophrenia.

How similar studies have performed: This approach is novel as it directly investigates the mechanism of action of dTMS for smoking cessation in patients with schizophrenia, with no prior studies reported on this specific combination.

Eligibility criteria

Inclusion Criteria:

1. Ages 18-60
2. DSM-5 criteria for schizophreniform, schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified (NOS).
3. DSM-5 diagnosis of nicotine use disorder with current daily smoking, and a desire to cut down or quit.
4. Negative urine toxicology (other than cannabis) maintained throughout study participation
5. Fluent English Speaker
6. Capacity for informed consent

Exclusion Criteria:

1. Clinically significant psychopathology other than schizophrenia, schizophreniform, schizoaffective disorder, or psychotic disorder NOS
2. Current or past substance use disorder, except TUD
3. Current use of smoking cessation medications/products
4. Change in schizophrenia medication within 4 weeks
5. Hospitalization in the last 3 months
6. History of suicidal or homicidal tendencies
7. History of epilepsy, stroke, cerebral aneurysm, significant head injury resulting in \>10 min loss of consciousness, movement disorder, clinically significant electrolyte abnormalities, or use of clozapine (seizure risks)
8. Pregnancy or lactation (females)
9. Lack of effective birth control (females)
10. Contraindications to MRI or PET
11. Clinical Global Impressions (CGI) rating of 6 (severely ill) or 7 (extremely ill)
12. Prisoners
13. Contraindications to dTMS\*

    * The FDA website currently states that the Brainsway device used in this study is contraindicated for patients who have "metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes." The investigators will monitor the FDA guidelines and implement any changes to the inclusion/exclusion criteria based on their most updated recommendations.

Where this trial is running

Stony Brook, New York

• Stony Brook University — Stony Brook, New York, United States (RECRUITING)

Study contacts

• Study coordinator: Anissa Abi-Dargham, MD

Conditions: Schizophrenia, Smoking Cessation, Tobacco Use, PET, UCB-J, fMRI