Tobacco Smoking in Schizophrenic PatientsSCARISNCT01979796
Antismoking Effects of Electronic Cigarettes in Subjects With Schizophrenia and Their Potential Influence on Cognitive Functioning.
A study testing Ecig 24 mg nicotine, Ecig 0 mg nicotine and Nicotine free inhalator in people with Tobacco Smoking in Schizophrenic Patients, run by University of Catania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Smoking in Schizophrenic Patients
- What is being tested?
- Ecig 24 mg nicotine, Ecig 0 mg nicotine and Nicotine free inhalator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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)
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.
Read the 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).
- Being tested
- Ecig 24 mg nicotine, Ecig 0 mg nicotine, Nicotine free inhalator
- Keywords
- Addiction, Schizophrenia, Electronic cigarettes
- Medical subject headings
- Behavior, Addictive, Schizophrenia, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecig 24 mg nicotineDevice
Cigalike
Ecig 0 mg nicotineDevice
Cigalike
Nicotine free inhalatorDevice
Plastic CIG a Like
| Study group | Role | What they receive |
|---|---|---|
| Ecig 24 mg nicotine | Experimental | Ecig 24 mg nicotine Receives: Device: Ecig 24 mg nicotine |
| Ecig 0 mg nicotine | Sham comparator | Ecig 0 mg nicotine Receives: Device: Ecig 0 mg nicotine |
| Nicotine free inhalator | Placebo comparator | Nicotine free inhalator Receives: Device: Nicotine free inhalator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 52 weeks
Secondary outcomes (1)
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".
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: We worked on a new dedicated protocolol GENESIS study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Smoking in Schizophrenic PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Polosa, University of Catania
- Investigators
- Pasquale Caponnetto, Assis Prof, Principal investigator, University of CataniaEugenio Aguglia, Professor, Principal investigator, University of CataniaGiuseppe Minutolo, Assis prof, Principal investigator, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979796
- Sponsor's protocol ID
- SCARIS
- Acronym
- SCARIS
- Status last verified
- May 2026
- First submitted
- 24 Oct 2013
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 24655473
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01979796
- Acronym / sponsor ID
- SCARIS / SCARIS
- Keywords
- Addiction, Schizophrenia, Electronic cigarettes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We worked on a new dedicated protocolol GENESIS study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ecig 24 mg nicotine | Experimental | Device: Ecig 24 mg nicotineEcig 24 mg nicotine |
| Ecig 0 mg nicotine | Sham comparator | Device: Ecig 0 mg nicotineEcig 0 mg nicotine |
| Nicotine free inhalator | Placebo comparator | Device: Nicotine free inhalatorNicotine free inhalator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecig 24 mg nicotineCigalike | Device | Ecig 24 mg nicotine |
| Ecig 0 mg nicotineCigalike | Device | Ecig 0 mg nicotine |
| Nicotine free inhalatorPlastic CIG a Like | Device | Nicotine free inhalator |
Primary outcome
smoking cessation
Time frame: 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").
1 secondary outcome
Smoking reduction
Time frame: 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 24655473Caponnetto 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasquale Caponnetto, Assis Prof principal investigator
University of Catania
Eugenio Aguglia, Professor principal investigator
University of Catania
Giuseppe Minutolo, Assis prof principal investigator
University of Catania
Questions about this trial
What is this clinical trial studying?
A study testing Ecig 24 mg nicotine, Ecig 0 mg nicotine and Nicotine free inhalator in people with Tobacco Smoking in Schizophrenic Patients, run by University of Catania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smoking cessation (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01979796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.