Role of an E-cigarette on Smoking Displacement in Smokers With Schizophrenia

NCT03075202 | Completed

• 1 other identifier: 1607017418
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

It is well established in the scientific literature that people with schizophrenia smoke tobacco cigarettes at rates up to three times that of the general population, relapse more frequently, and die an average of 25 years earlier from cigarette smoking and other life-style attributable illnesses. Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide and new research suggests that e-cigarettes are appealing to smokers with schizophrenia. There is a paucity of research focused on the experience of smokers with schizophrenia who decide to try an e-cigarette. A well-designed prospective-observational study is needed to learn more about the influence of e-cigarette use on cigarette smoking behavior and mental and physical health among smokers with schizophrenia. In response, the investigators have designed a study titled, Role of an electronic cigarette on smoking displacement in smokers with schizophrenia: A prospective 3-month pilot study (SchizEcig).

Conditions

Schizophrenia and Related Disorders

Keywords

Schizophrenia; Smoking; E-cigarette

Outcome Measures

Primary Outcomes (1)

• Smoking Displacement

  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 Outcomes (1)

• Partial Displacement

  3-months

Interventions

e-cigarette, brand name JUUL DEVICE

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.

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants, age 21 to 65 years, will have a DSM 5 schizophrenia spectrum disorder diagnosis without evidence of exacerbation of illness as indicated by no relapse to hospitalization within the last three months and no change in their antipsychotic treatment within the last month. Participants will smoke 20 or more conventional tobacco cigarettes per day and at least 100 cigarettes in their lifetime and do not intend to reduce or quit smoking.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Hunter College of The City University of New York: collaborator
• University of Catania: collaborator
• University of Stirling: collaborator

Study Sites (1)

Clinical and Translational Science Center, Weill Cornell Medicine, 525 E 68th Street, F-260

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Schizophrenia; Smoking; Vaping

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 9, 2017
• Study Start: March 3, 2017
• Primary Completion: December 24, 2018
• Study Completion: December 24, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)