Circuitry-Guided Smoking Cessation in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT03281629|
Recruitment Status : Not yet recruiting
First Posted : September 13, 2017
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Nicotine Addiction Schizophrenia||Device: Active TMS stimulation Device: Sham TMS stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Circuitry-Guided Smoking Cessation in Schizophrenia|
|Estimated Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Active Comparator: Active TMS stimulation
Real active rTMS stimulation.
Device: Active TMS stimulation
Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
Sham Comparator: Sham TMS stimulation
Sham repetitive TMS stimulation.
Device: Sham TMS stimulation
Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
- Cigarette per day [ Time Frame: 7 months ]Cigarette per day (CPD) is measured to index smoking reduction and cessation.
- Functional magnetic resonance imaging (fMRI) [ Time Frame: 7 months ]fMRI is used to evaluate the brain activities that are corresponding to the TMS effect on smoking reduction/cessation.
- Cotinine [ Time Frame: 7 months ]Cotinine level is an objective index of smoking status.
- End-expired carbon monoxide (CO) [ Time Frame: 7 months ]End-expired CO measure is an instant measure of smoking status.
- Electroencephalography (EEG) [ Time Frame: 7 months ]EEG is used to evaluate the brain activities that are corresponding to the TMS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281629
|Contact: Xiaoming Du, PhDfirstname.lastname@example.org|
|Contact: Dawn Detamoreemail@example.com|
|United States, Maryland|
|University of Maryland, Baltimore|
|Baltimore, Maryland, United States, 21228|
|Principal Investigator:||Xiaoming Du, MD||University of Maryland|