Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)
NCT ID: NCT05276050
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2022-06-01
2027-01-30
Brief Summary
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Detailed Description
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The F8 coil based rTMS is not FDA approved for smoking cessation at this point, the rTMS with H4 coil is FDA-cleared for short-term smoking cessation in the general population, its efficacy in SSD has not been evaluated. In this protocol, the investigators will compare them in patients with schizophrenia spectrum disorders.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Study group
Participants in this group will receive active F8-coil delivered rTMS.
active F8-coil delivered rTMS
Multiple trains of rTMS in a day, for multiple days.
Active control group
Participants in this group will receive active H-coil delivered rTMS.
active H-coil delivered rTMS
Multiple trains of rTMS in a day, for multiple days.
Interventions
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active F8-coil delivered rTMS
Multiple trains of rTMS in a day, for multiple days.
active H-coil delivered rTMS
Multiple trains of rTMS in a day, for multiple days.
Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Xiaoming Du
Assistant Professor
Principal Investigators
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Xiaoming Du, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center, Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-23-0632
Identifier Type: -
Identifier Source: org_study_id
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