Antismoking Effects of Electronic Cigarettes in Subjects With Schizophrenia and Their Potential Influence on Cognitive Functioning.

Study Overview
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Brief Summary
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It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. To date there are no large randomised trials of e-cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population.

Detailed Description
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The investigators have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. The investigators will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product. The main strengths of the SCARIS study are the following: it's the first large RCT on schizophrenic patient, involving in and outpatient, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks).

Official Title
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Antismoking Effects of Electronic Cigarettes in Subjects With Schizophrenia and Their Potential Influence on Cognitive Functioning: Design of a Randomized Trial. Smoking Cessation And Reduction In Schizophrenia (The SCARIS Study)

Conditions
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Tobacco Smoking in Schizophrenic Patients

Intervention / Treatment
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* Device: Ecig 24 mg nicotine
* Device: Ecig 0 mg nicotine
* Device: Nicotine free inhalator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schizophrenic subjects (according to DSM-IV-TR criteria) from throughout Sicily, (Italy), who smoke tobacco cigarettes, in stable phase of illness. smoke ≥10 factory made cig/day, for at least the past five years age 18-65 years in good general health not currently attempting to quit smoking or wishing to do so in the next 30 days (a specific test will be included to check their unwillingness to quit) 6 months committed to follow the trial procedures. Exclusion Criteria: use of smokeless tobacco or nicotine replacement therapy pregnancy or breastfeeding. current or recent (less than 1 yr) past history of alcohol and/or drug abuse other significant co-morbidities according to the Investigator's clinical assessment

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ecig 24 mg nicotine<br>Ecig 24 mg nicotine | Device: Ecig 24 mg nicotine<br>* Cigalike<br>|
| Sham Comparator: Ecig 0 mg nicotine<br>Ecig 0 mg nicotine | Device: Ecig 0 mg nicotine<br>* Cigalike<br>|
| Placebo Comparator: Nicotine free inhalator<br>Nicotine free inhalator | Device: Nicotine free inhalator<br>* Plastic CIG a Like<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking cessation | Abstinence from smoking, defined as complete self-reported abstinence from tobacco smoking - not even a puff (together with an eCO concentration of ≤7 ppm), will be calculated at each study visit (quitters). | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking reduction | A ≥50% reduction in the number of cig/day from baseline, defined as self-reported reduction in the number of cig/day (≥50%) compared to baseline (together with an eCO levels reduction, to objectively document a reduction from baseline), will be calculated at each study visit (reducers). Smokers who will not satisfy the criteria of reducers and quitters will be defined non responders. | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Addiction, Schizophrenia, Electronic cigarettes