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

Primary Purpose

Tobacco Smoking in Schizophrenic Patients

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ecig 24 mg nicotine
Ecig 0 mg nicotine
Nicotine free inhalator
Sponsored by
Universita degli Studi di Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Smoking in Schizophrenic Patients focused on measuring Addiction, Schizophrenia, Electronic cigarettes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    Placebo Comparator

    Arm Label

    Ecig 24 mg nicotine

    Ecig 0 mg nicotine

    Nicotine free inhalator

    Arm Description

    Ecig 24 mg nicotine

    Ecig 0 mg nicotine

    Nicotine free inhalator

    Outcomes

    Primary Outcome Measures

    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").

    Secondary Outcome Measures

    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".

    Full Information

    First Posted
    October 24, 2013
    Last Updated
    May 16, 2022
    Sponsor
    Universita degli Studi di Catania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01979796
    Brief Title
    Antismoking Effects of Electronic Cigarettes in Subjects With Schizophrenia and Their Potential Influence on Cognitive Functioning.
    Acronym
    SCARIS
    Official Title
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universita degli Studi di Catania

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tobacco Smoking in Schizophrenic Patients
    Keywords
    Addiction, Schizophrenia, Electronic cigarettes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    153 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ecig 24 mg nicotine
    Arm Type
    Experimental
    Arm Description
    Ecig 24 mg nicotine
    Arm Title
    Ecig 0 mg nicotine
    Arm Type
    Sham Comparator
    Arm Description
    Ecig 0 mg nicotine
    Arm Title
    Nicotine free inhalator
    Arm Type
    Placebo Comparator
    Arm Description
    Nicotine free inhalator
    Intervention Type
    Device
    Intervention Name(s)
    Ecig 24 mg nicotine
    Intervention Description
    Cigalike
    Intervention Type
    Device
    Intervention Name(s)
    Ecig 0 mg nicotine
    Intervention Description
    Cigalike
    Intervention Type
    Device
    Intervention Name(s)
    Nicotine free inhalator
    Intervention Description
    Plastic CIG a Like
    Primary Outcome Measure Information:
    Title
    smoking cessation
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Smoking reduction
    Description
    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
    Other Pre-specified Outcome Measures:
    Title
    Evaluation of neurocognitive functioning
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pasquale Caponnetto, Assis Prof
    Organizational Affiliation
    University of Catania
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Eugenio Aguglia, Professor
    Organizational Affiliation
    University of Catania
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Giuseppe Minutolo, Assis prof
    Organizational Affiliation
    University of Catania
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24655473
    Citation
    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.
    Results Reference
    derived

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

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