Clinical trial NCT03075202: Role of an E-cigarette on Smoking Displacement in Smokers With Schizophrenia
Official title: Role of an E-cigarette on Smoking Displacement in Smokers With Schizophrenia: A Prospective 3-month Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia and Related Disorders
Keywords: Schizophrenia
Smoking
E-cigarette
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Hunter College of The City University of New York
name: University of Catania
name: University of Stirling
First posted: 2017-03-09
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility 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

Primary outcomes:
measure: Smoking Displacement
timeFrame: 3-months
Secondary outcomes:
measure: Partial Displacement
timeFrame: 3-months
Other outcomes:
Locations:
city: New York
country: United States
facility: Clinical and Translational Science Center, Weill Cornell Medicine, 525 E 68th Street, F-260
state: New York
Study officials:
affiliation: Hunter College at The City University of New York
name: Jennifer DiPiazza-Sileo, PhD, PMHNP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Catania
name: Caponnetto Pasquale, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Jason J Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: