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

• ClinicalTrials.gov Identifier: NCT03075202
• Recruitment Status: Completed
• First Posted: March 9, 2017
• Last Update Posted: January 11, 2019
• Sponsor: Weill Medical College of Cornell University
• Collaborators: Hunter College of The City University of New York; University of Catania; University of Stirling
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Study Description

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).

Condition or disease	Intervention/treatment
Schizophrenia and Related Disorders	Device: e-cigarette, brand name JUUL

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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

Groups and Cohorts

Intervention Details:

• 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Weill Medical College of Cornell University

Hunter College of The City University of New York

University of Catania

University of Stirling

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

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03075202
• Other Study ID Numbers: 1607017418
• First Posted: March 9, 2017
• Last Update Posted: January 11, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Individual participant data may be available to some collaborating researchers, but not all.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Weill Medical College of Cornell University:

Schizophrenia; Smoking; E-cigarette

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders