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

Not Applicable

Not yet recruiting

• Conditions: Tobacco Smoking in Schizophrenic Patients
• Interventions: Device: Ecig 0 mg nicotine; Device: Ecig 24 mg nicotine; Device: Nicotine free inhalator

• Registration Number: NCT01979796
• Lead Sponsor: Universita degli Studi di Catania

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).

Study Timeline

• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-11-02
• Study First Posted: 2013-11-08
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17
• Study Start: 2022-12
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ecig 0 mg nicotine	Ecig 0 mg nicotine	Ecig 0 mg nicotine
Ecig 24 mg nicotine	Ecig 24 mg nicotine	Ecig 24 mg nicotine
Nicotine free inhalator	Nicotine free inhalator	Nicotine free inhalator

Primary Outcome Measures

Name	Time	Method
smoking cessation	52 weeks	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").

Secondary Outcome Measures

Name	Time	Method
Smoking reduction	52 weeks	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".