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

Schizophrenia and Related Disorders Clinical Trial

Official title:

Role of an E-cigarette on Smoking Displacement in Smokers With Schizophrenia: A Prospective 3-month Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075202
• Other study ID #: 1607017418
• Status: Completed
• Start date: March 3, 2017
• Est. completion date: December 24, 2018

Study information

• Verified date: January 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

This is a prospective 3 month pilot study to observe cigarette use behavior among people with a schizophrenia spectrum disorder diagnosis who smoke conventional tobacco cigarettes, do not intend to reduce or quit smoking, and are invited to use an e-cigarette. The investigators are interested to know if e-cigarette use is associated with cigarette smoking displacement. Displacement is defined as switching from conventional tobacco cigarettes to e-cigarettes. The investigators will also monitor for physical and mental health, including blood pressure, weight, and scores from the Scale for the Assessment of Negative Symptoms (SANS) and the Scale for the Assessment of Positive Symptoms (SAPS) as well as any reported adverse events participants' feel are attributed to e-cigarette use and participants' perceptions of the sensory experience associated with e-cigarette use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 24, 2018
• Est. primary completion date: December 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia and Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Clinical and Translational Science Center, Weill Cornell Medicine, 525 E 68th Street, F-260	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Hunter College of The City University of New York, University of Catania, University of Stirling

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Partial Displacement	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