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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Smoking in Schizophrenic Patients
• Intervention / Treatment: Device: Ecig 24 mg nicotine; Device: Ecig 0 mg nicotine; Device: Nicotine free inhalator

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 Type: Interventional
• Enrollment (Anticipated): 153
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ecig 24 mg nicotine	Device: Ecig 24 mg nicotine; Cigalike
Sham Comparator: Ecig 0 mg nicotine	Device: Ecig 0 mg nicotine; Cigalike
Placebo Comparator: Nicotine free inhalator	Device: Nicotine free inhalator; Plastic CIG a Like

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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").	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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').	52 weeks

Collaborators and Investigators

• Sponsor: Universita degli Studi di Catania
• Investigators: Principal Investigator: Pasquale Caponnetto, Assis Prof, University of Catania; Principal Investigator: Eugenio Aguglia, Professor, University of Catania; Principal Investigator: Giuseppe Minutolo, Assis prof, University of Catania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: November 2, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Addiction, Schizophrenia, Electronic cigarettes
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: SCARIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No