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| ID | Type | Description | Link |
|---|---|---|---|
| UH3DA047685 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
Neuroimaging studies suggest that high rate of smoking in patients with schizophrenia may be due to an overlap of nicotine addiction-related circuitries and schizophrenia-related circuitries, such that schizophrenia impacts some of the same circuitries that increase risks for severe nicotine addiction in general. Those identified overlapping circuitries have been linked to several key features of nicotine addiction and can be represented by resting-state functional connectivities. The investigators aim to develop a TMS method targeting special brain circuits that are both smoking cessation and schizophrenia-related. If the corresponding brain circuits were successfully modulated, the treatment efficacy will be significantly improved and schizophrenia patients will benefit from the TMS treatment of smoking cessation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Participants in this group will receive active F8-coil delivered rTMS. |
|
| Active control group | Active Comparator | Participants in this group will receive active H-coil delivered rTMS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active F8-coil delivered rTMS | Device | Multiple trains of rTMS in a day, for multiple days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Resting-state functional connectivity (rsFC) from functional magnetic resonance imaging (fMRI) | The strength of rsFC from fMRI is used to represent the brain activities that are corresponding to the TMS effect on smoking reduction/cessation. | 1 month |
| Cigarette per day | Cigarette per day (CPD) is measured to index smoking reduction and cessation. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Fagerstrom Test for Nicotine Dependence (FTND) | Fagerstrom Test for Nicotine Dependence (FTND) represents the severity of nicotine severity. | 1 month |
| nicotine/creatinine | nicotine/creatinine is a index of smoking status. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoming Du, PhD | Contact | 443-882-9717 | Xiaoming.Du@uth.tmc.edu | |
| Victoria Acosta | Contact | 713-486-2740 | Victoria.Acosta@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoming Du, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center, Houston | Recruiting | Houston | Texas | 77054 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| D012559 | Schizophrenia |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| active H-coil delivered rTMS |
| Device |
Multiple trains of rTMS in a day, for multiple days. |
|
| 1 month |
| End-expired carbon monoxide (CO) | End-expired CO measure is an instant measure of smoking status. | 1 month |
| D001523 |
| Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |