- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03075202
Role of an E-cigarette on Smoking Displacement in Smokers With Schizophrenia
Role of an E-cigarette on Smoking Displacement in Smokers With Schizophrenia: A Prospective 3-month Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Clinical and Translational Science Center, Weill Cornell Medicine, 525 E 68th Street, F-260
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Clinical diagnosis of a schizophrenia spectrum disorder
Non-hospitalized persons
Regular smokers who report smoking 20 or more cigarettes per day who have smoked at least 100 cigarettes in their lifetime, and are not intending to reduce or quit
Has agreed to try an e-cigarette
Must be able to provide written informed consent
Must be able to read, write and communicate in English proficiently
Must have access to a computer with internet
Must have the ability to work a computer and navigate the internet easily
Exclusion Criteria:
Non-smokers Persons without a schizophrenia spectrum disorder diagnosis
Hospitalized persons
Cardio vascular disease
Respiratory disease
Use of smokeless tobacco or any other tobacco products besides cigarettes.
Use of nicotine replacement therapy or other smoking cessation pharmaco-therapies within the last 3 months
Pregnancy or breastfeeding
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3-months
|
Collaborators and Investigators
Collaborators
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1607017418
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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