Using brain stimulation to help people with schizophrenia quit smoking
Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)
This study tests whether a type of brain stimulation can help people with schizophrenia quit smoking by comparing two different methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05276050 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of repetitive transcranial magnetic stimulation (rTMS) to aid smoking cessation in patients diagnosed with schizophrenia spectrum disorder. Participants will receive either active rTMS from an F8 coil or an H coil, with their smoking habits and brain connectivity monitored throughout the process. The goal is to target specific brain circuits associated with both nicotine addiction and schizophrenia to enhance treatment efficacy. The study aims to compare the effectiveness of these two rTMS methods in this unique patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22-65 with a diagnosis of schizophrenia spectrum disorder who have been smoking regularly.
Not a fit: Patients who do not smoke or have not smoked in the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve smoking cessation rates among individuals with schizophrenia, enhancing their overall health and quality of life.
How similar studies have performed: While the use of rTMS for smoking cessation is FDA-cleared for the general population, its efficacy in patients with schizophrenia has not been previously evaluated, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female between ages 22-65 years 2. Ability to give written informed consent 3. Smoking in the last one year or more and average cigarette per day ≥ 5 in the past 4 weeks 4. Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above10. 5. Is currently under the care of a licensed primary care provider or mental healthcare provider (e.g., psychiatrist, psychologist, nurse practitioner, licensed clinical social worker). 6. Agrees to: (a) provide written permission, as requested, to allow any and all forms of communication between the investigators and study staff and any health care provider who currently provides and/or has provided service to the subject within two years of study enrollment; and (b) provide the names and verifiable contact information (name, email and mailing address, mobile and land-line phone number, as applicable) of at least two reliable persons ≥ age 22, who reside within a 30-minute drive of the subject's residence, and whom the research staff is at liberty to contact, as deemed necessary, for the duration of study participation. Exclusion Criteria: 1. Persons with a first-degree relative with inherited epilepsy, seizure disorder, or seizures or persons who answer "yes" to any of the parts (A. - G.) of Question 3 of an epilepsy screening questionnaire. 2. Had smoking cessation treatment, clinical trial, or nicotine replacements within the past four weeks. 3. Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence. 4. Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection or tumor, other significant brain neurological conditions. 5. Taking \> 400 mg clozapine/day or Failed TMS screening questionnaire. 6. Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed. 7. History of head injury with loss of consciousness over 10 minutes; history of brain surgery 8. Cannot refrain from using alcohol and/or marijuana 24 hours or more \& cigarette smoking one hour or more prior to experiments. 9. Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test) or has had unprotected sexual intercourse without birth control in the last 4 weeks. 10. Moderate-High Risk of suicide according to the Columbia - Suicide Severity Rating Scale (C- SSRS) Screen Version - Recent (i.e. answers YES to Question 3 and NO to Question 6 (Moderate risk); or answers YES to Questions 4, 5, or 6 (High risk) or in the clinical judgement of the investigator or the study psychiatrist. 11. In the medical opinion of the investigator, subjects with the following circumstances or conditions which can increase the risk of seizures may be excluded: sleep deprivation; major depressive disorder comorbid with dementia, underweight status; concurrent use of cephalosporins and antiarrhythmics (particularly propranolol); metabolic abnormalities (hyponatremia, hypocalcemia, hypomagnesemia, hypoglycemia, hyperglycemia, renal failure/uremia, liver failure); raised blood concentrations of proconvulsant medications due to reduced clearance (e.g. secondary to initiation of antibiotics for treatment of infections); alcohol withdrawal; use of stimulants, such as cocaine or MDMA; use of immunosuppressive therapy with cyclosporine, tacrolimus and other agents that can cause the posterior reversible leukoencephalopathy syndrome; dialysis; systemic infection, and fever itself.
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center, Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Xiaoming Du, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Xiaoming Du, PhD
- Email: Xiaoming.Du@uth.tmc.edu
- Phone: 443-882-9717
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.