An interventional study of Ecig 24 mg nicotine and Ecig 0 mg nicotine in Tobacco Smoking in Schizophrenic Patients, sponsored by University of Catania. Withdrawn. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University of Catania · Not applicable, Interventional, and Treatment
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.
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).
540 studies on the registry are indexed under Behavior, Addictive; 134 are open to participants now.
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Exclusion Criteria:
Ecig 24 mg nicotine
Device: Ecig 24 mg nicotine
Ecig 0 mg nicotine
Device: Ecig 0 mg nicotine
Nicotine free inhalator
Device: Nicotine free inhalator
Cigalike
Cigalike
Plastic CIG a Like
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").
Time frame: 52 weeks
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".
Time frame: 52 weeks
Evaluation of neurocognitive functioning
Quality of life, Neurocognitive Functioning and Psychopathological status will be assessed at each study visit by Quality of Life Scale (QLS), Brief Assessment of Cognition in Schizophrenia (BACS) and Positive and Negative Symptoms Scale(PANSS), respectively Participants' perception and liking of the product will be assessed by asking to rate their level of satisfaction with the products compared to their own cigarettes using a visual analogue scale (VAS) from 0 to 10 points (0 = being 'completely unsatisfied', 10 being = 'fully satisfied'); using the same scale, they will also rate how much they miss their own brand (0 = being 'did not miss it at all', 10 being = 'missed too much') and whether they would recommend it to a friend/relative (0 = being 'not recommended at all', 10 being = 'absolutely recommended').
Time frame: 52 weeks
No study locations are listed for this record.
This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Catania