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Smoking cessation and reduction in schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control
Pasquale Caponnetto1, Riccardo Polosa, Roberta Auditore
1Smoking Prevention/Cessation Centre, A,O,U, Policlinico-V,Emanuele, Department of Clinical and Molecular Biomedicine, University of Catania, Catania, Italy. p.caponnetto@unict.it.
Trials
|March 25, 2014
Summary
This study investigates electronic cigarette efficacy and safety in schizophrenic smokers. It aims to reduce smoking risks and improve quality of life in this population.
Area of Science:
- Psychiatry
- Addiction Medicine
- Clinical Trials
Background:
- Tobacco smoking is highly prevalent in schizophrenia patients.
- Electronic cigarettes (e-cigarettes) are increasingly popular globally.
- Limited large-scale randomized trials exist for e-cigarettes in schizophrenic smokers.
Purpose of the Study:
- To evaluate the efficacy and safety of e-cigarettes in schizophrenic smokers not intending to quit.
- To assess smoking reduction, abstinence rates, and adverse events.
- To monitor quality of life, neurocognitive function, and product satisfaction.
Main Methods:
- Prospective 12-month randomized clinical trial.
- Involves schizophrenic smokers, both inpatient and outpatient.
- Utilizes a three-arm study design with long-term follow-up (52 weeks).
Main Results:
- Smoking reduction defined as ≥50% decrease in cigarettes/day.
- Smoking abstinence assessed at study visits.
- Non-responders include early terminators and those not meeting reduction/abstinence criteria.
Conclusions:
- The SCARIS study is the first large RCT on e-cigarettes in schizophrenic patients.
- Aims to provide an effective intervention for tobacco addiction in schizophrenia.
- Seeks to reduce smoking-related risks in this vulnerable population.
