Caponnetto 2014

Trial name or title	Smoking cessation and reduction In schizophrenia (the SCARIS study)
Methods	3‐arm prospective 12m randomized controlled trial investigating efficacy and safety of EC Setting: psychiatric and smoking cessation centres, Italy Recruitment: local newspapers and radio/television advertisements
Participants	153 participants, schizophrenic in stable phase of illness, smoked at least 10 cpd over previous 5 years, aged 18 ‐ 65, in good general health, not currently attempting to quit smoke or wishing to do so in next 6m Excluded if: use smokeless tobacco or NRT; pregnant or breastfeeding; current or recent (1 yr) history of drug or alcohol abuse; other significant co‐morbidities
Interventions	12‐wk supply of: 1) EC, high nicotine (24 mg) 2) EC, no nicotine (0 mg, with tobacco aroma) 3) PAIPO nicotine‐free inhalator
Outcomes	Follow‐up visits at 4, 8, 12, 24 and 52 wks Outcome measures: Smoking cessation Smoking reduction (≥ 50% from baseline) Adverse events Quality of life Neurocognitive functioning Participant perceptions and satisfactions with products
Starting date	September 2014
Contact information	Pasquale Caponnetto, p.caponnetto@unict.it
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