Actively Recruiting
Circuitry-Guided Smoking Cessation in Schizophrenia Using F8 and H-Coil rTMS Devices
Led by The University of Texas Health Science Center, Houston · Updated on 2026-01-12
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with schizophrenia spectrum disorder (SSD) who smoke to compare two types of repetitive transcranial magnetic stimulation (rTMS) treatments using different coils, the F8 coil and the H coil, for helping with smoking cessation. The study aims to explore how these treatments affect smoking habits and brain function, especially focusing on brain circuits linked to both schizophrenia and nicotine addiction. This research may improve smoking cessation approaches for people with SSD by targeting these overlapping brain circuits. Participants will receive multiple sessions of active rTMS using either the F8 coil or the FDA-cleared H coil, which is currently approved for short-term smoking cessation in the general population but not yet tested in SSD patients. These treatments involve repeated magnetic stimulation sessions over several days aiming to modulate brain activity associated with smoking and schizophrenia. Two groups will be compared, one receiving F8-coil rTMS and the other H-coil rTMS. Throughout the study, participants will be evaluated at baseline, during treatment, and at follow-up stages using brain imaging (functional MRI) to assess resting-state functional connectivity changes. Researchers will also measure cigarettes smoked per day, nicotine dependence levels, nicotine and creatinine in the body, and carbon monoxide in breath to monitor smoking behavior and biological effects. The study includes safety monitoring and data collection lasting at least one month after treatment begins.
CONDITIONS
Brief Title
Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female between ages 22-65 years
- Ability to give written informed consent
- Smoking in the last one year or more with average cigarette per day of 5 or more in the past 4 weeks
- Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10
- Currently under care of a licensed primary care provider or mental healthcare provider
- Agrees to provide written permission for communication between investigators and healthcare providers and contact information for two reliable persons aged 22 or older living nearby
You will not qualify if you...
- First-degree relative with inherited epilepsy, seizure disorder, or seizures or positive epilepsy screening questionnaire
- Received smoking cessation treatment, clinical trial, or nicotine replacements within the past 4 weeks
- Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) except nicotine or marijuana dependence
- Major medical illnesses affecting normal brain function (e.g., stroke, CNS infection, brain tumor, neurological conditions)
- Taking more than 400 mg clozapine/day or failed TMS screening
- Presence of cardiac pacemakers, implanted pumps, intracardiac lines, unstable cardiac disease, intracranial implants, or metal objects near the head that cannot be removed safely
- History of head injury with loss of consciousness over 10 minutes or brain surgery
- Unable to refrain from alcohol, marijuana 24 hours or more, or cigarette smoking one hour or more before experiments
- Pregnant women or those with recent unprotected sex without birth control
- Moderate to high risk of suicide based on Columbia Suicide Severity Rating Scale or clinical judgment
- Conditions increasing risk of seizures such as sleep deprivation, major depressive disorder with dementia, metabolic abnormalities, certain medications, alcohol withdrawal, stimulant use, immunosuppressive therapy, dialysis, systemic infection, or fever
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Multiple days
Participants receive multiple trains of rTMS per day using either the F8 coil or the H-coil over multiple days as part of smoking cessation treatment.
Multiple visits during treatment days
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center, Houston
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
X
Xiaoming Du, PhD
V
Victoria Acosta
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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