Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Mar 2, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new method to help people with schizophrenia who want to quit smoking. The study will use a technique called repetitive transcranial magnetic stimulation (rTMS), which involves sending magnetic pulses to the brain to support smoking cessation. Researchers will look at how smoking habits and brain activity change during the treatment and at follow-up visits.

To participate, individuals need to be between 22 and 65 years old, have been diagnosed with schizophrenia, and have smoked at least five cigarettes a day in the past month. They must also be under the care of a healthcare provider and able to give consent. Participants will need to agree to share information with the study team and provide contact details for two reliable people. It's important to note that there are certain health conditions and recent treatments that may exclude someone from joining the trial. If eligible, participants can expect to engage in rTMS sessions and will be monitored throughout the study to assess their progress.

Gender

ALL

Eligibility 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.