RecruitingNot applicable

Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two types of repetitive transcranial magnetic stimulation (rTMS), which uses magnetic pulses to stimulate the brain, to help people quit smoking. It is for adults ages 22–65 with schizophrenia or a related disorder who smoke. Researchers will track smoking and changes in how parts of the brain work together.

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from F8 coil or active rTMS from H coil for smoking cessation. Smoking and brain functional connectivity changes will be assessed at baseline, different stages of rTMS and/or follow-ups.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 22–65 years old.
  • You can give written consent to join and score above 10 on a test of your ability to consent.
  • You have smoked for at least one year and averaged at least 5 cigarettes a day over the past 4 weeks.
  • You have been diagnosed with schizophrenia or a related disorder.
  • You are currently cared for by a licensed primary care or mental health provider.
  • You agree to let study staff communicate with your current health care providers and those who treated you in the past 2 years.
  • You provide contact details for at least 2 reliable people age 22 or older who live within a 30-minute drive of you. You agree that study staff may contact them during the study.

Who can't join

  • A parent, sibling, or child has inherited epilepsy or a seizure disorder, or you answer yes to certain seizure screening questions.
  • You had treatment to quit smoking, used nicotine replacement, or took part in a clinical trial in the past 4 weeks.
  • You had alcohol or drug dependence in the past 6 months, or substance abuse in the past month, except dependence on nicotine or marijuana. You cannot avoid alcohol and marijuana for at least 24 hours and cigarettes for at least 1 hour before study tests.
  • You have a major illness that affects the brain, had brain surgery, or had a head injury that left you unconscious for more than 10 minutes.
  • You take more than 400 mg of clozapine a day or do not pass the TMS safety screening.
  • You have a pacemaker, implanted medicine pump, a line inside the heart, unstable heart disease, or an implant or metal in or near your head that cannot be safely removed. Metal in the mouth is excepted.
  • You are pregnant, had sex without birth control in the past 4 weeks, or have a moderate to high risk of suicide based on screening or the study clinician's judgment.
  • The study doctor may exclude you for other seizure risks, such as too little sleep, being underweight, certain medicines or drugs, alcohol withdrawal, abnormal blood sugar or mineral levels, kidney or liver failure, dialysis, infection, or fever.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX