Circuitry-Guided Smoking Cessation in Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03281629|
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : June 25, 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|
|Actual Study Start Date :||May 18, 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||Recruiting|
|Baltimore, Maryland, United States, 21228|
|Contact: Xiaoming Du, PhD 410-402-6036 firstname.lastname@example.org|
|Contact: Dawn Detamore 410-402-6820 email@example.com|
|Principal Investigator:||Xiaoming Du, MD||University of Maryland|