Role of an E-cigarette on Smoking Displacement in Smokers With 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03075202|
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment|
|Schizophrenia and Related Disorders||Device: e-cigarette, brand name JUUL|
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||Role of an E-cigarette on Smoking Displacement in Smokers With Schizophrenia: A Prospective 3-month Pilot Study|
|Actual Study Start Date :||March 3, 2017|
|Actual Primary Completion Date :||December 24, 2018|
|Actual Study Completion Date :||December 24, 2018|
- Device: e-cigarette, brand name JUUL
This is not an experimental study/trial, rather a prospective observational study. Device will be offered to cohort, but they are not mandated to take or use the device.
- Smoking Displacement [ Time Frame: 3-months ]The primary endpoint of this study is the proportion of study participants with a self-reported complete displacement from tobacco cigarette smoking - not even a puff in between study visits, along with confirmatory eCO values ≤10 ppm at each study visit. These participants will be referred to as "Displacers". Discrepancies between self-report and eCO measures will be handled on a case-by-case basis. To assure an accurate eCO reading participants will be asked not to smoke cigarettes within one hour of the study visit.
- Partial Displacement [ Time Frame: 3-months ]Partial displacement will be defined as a minimization in cigarette consumption by ≥50% in the number of tobacco cigarettes smoked per day from baseline to the final visit (week 12) by participants' self-report together with an eCO decline from baseline.. The measures will be taken at each study visit. These participants will be referred to as "Partial Displacers". Discrepancies between self-report and eCO measures will be handled on a case-by-case basis. To assure an accurate eCO reading participants will be asked not to smoke cigarettes within one hour of the study visit.
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): NCT03075202
|United States, New York|
|Clinical and Translational Science Center, Weill Cornell Medicine, 525 E 68th Street, F-260|
|New York, New York, United States, 10065|
|Principal Investigator:||Jennifer DiPiazza-Sileo, PhD, PMHNP||Hunter College at The City University of New York|
|Principal Investigator:||Caponnetto Pasquale, PhD||University of Catania|
|Principal Investigator:||Jason J Kim, MD||Weill Medical College of Cornell University|