Clinical trial NCT01979796: Antismoking Effects of Electronic Cigarettes in Subjects With Schizophrenia and Their Potential Influence on Cognitive Functioning.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Smoking in Schizophrenic Patients
Keywords: Addiction, Schizophrenia, Electronic cigarettes
Lead sponsor: Universita degli Studi di Catania
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: smoking cessation
timeFrame: 52 weeks
Secondary outcomes:
measure: Smoking reduction
timeFrame: 52 weeks
Other outcomes:
measure: Evaluation of neurocognitive functioning
timeFrame: 52 weeks
Locations:
Study officials:
affiliation: University of Catania
name: Pasquale Caponnetto, Assis Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Catania
name: Eugenio Aguglia, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Catania
name: Giuseppe Minutolo, Assis prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caponnetto P, Polosa R, Auditore R, Minutolo G, Signorelli M, Maglia M, Alamo A, Palermo F, Aguglia E. Smoking cessation and reduction in schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial. Trials. 2014 Mar 22;15:88. doi: 10.1186/1745-6215-15-88.