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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Schizophrenia and Related Disorders

Intervention / Treatment
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* Device: e-cigarette, brand name JUUL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Smoking, E-cigarette