Tobacco Smoking in Depressed PatientsscaridNCT02124187
Smoking Cessation And Reduction in Depression
A study testing Ecig 24 mg nicotine, Ecig 0 mg nicotine and Nicotine free inhalator in people with Tobacco Smoking in Depressed Patients, run by University of Catania at 1 site in Italy.
Trial summary
It is well established in studies across several countries that tobacco smoking is more prevalent among depressed patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking in Depressed 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
- 1 siteItaly
- Study dates
- Dec 2022to Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Major Depressive Disorder (MDD) (according to DSM 5 criteria) from throughout Sicily (Italy), who smoke tobacco cigarettes.
- smoke ≥10 factory made cig/day, for at least the past five years
- age 18-65 years
- in good general health (in absence of cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis )
- 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 or other smoking cessation therapies
- pregnancy or breastfeeding
- current or recent (less than 1 yr) past history of alcohol and/or drug abuse
- active suicidal intention
- other significant co-morbidities according to the Investigator's clinical assessment (e.g. cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOU Policlinico - Vittorio Emanuele di Catania
Catania, Sicily, 95100
About this study
It is well established in studies across several countries that tobacco smoking is more prevalent among depressed patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in depressed smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population.
We 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 depressed smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product.
Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders".
- Conditions
- Tobacco Smoking in Depressed Patients
- Being tested
- Ecig 24 mg nicotine, Ecig 0 mg nicotine, Nicotine free inhalator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecig 24 mg nicotineDevice
eCig 24 mg nicotine for 12 weeks
Ecig 0 mg nicotineDevice
eCig 0 mg nicotine for 12 weeks
Nicotine free inhalatorDevice
eCig 24 mg nicotine for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| eCig 24 mg nicotine | Experimental | eCig 24 mg nicotine for 12 weeks Receives: Device: Ecig 24 mg nicotine |
| Ecig 0 mg nicotine | Sham comparator | eCig 0 mg nicotine for 12 weeks Receives: Device: Ecig 0 mg nicotine |
| Nicotine free inhalator | Placebo comparator | nicotine free inhalator for 12 weeks 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").
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 posted28 Apr 2014 (estimated)
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Why it stopped: We started with a dedicated protocolol GENESIS RCT
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 Depressed 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
- Collaborators
- Lega Italiana Anti Fumo
- Responsible party
- Principal investigator, Riccardo Polosa, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124187
- Sponsor's protocol ID
- SCARID
- Acronym
- scarid
- Status last verified
- May 2026
- First submitted
- 24 Apr 2014
- 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
- Smoking Cessation And Reduction in Depression
- ClinicalTrials.gov ID
- NCT02124187
- Acronym / sponsor ID
- scarid / SCARID
- Conditions
- Tobacco Smoking in Depressed Patients
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We started with a dedicated protocolol GENESIS RCT
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Collaborators
- Lega Italiana Anti Fumo
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 28 Apr 2014 (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 depressed patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in depressed smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population.
We 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 depressed smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product.
Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders".
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 for 12 weeks |
| Ecig 0 mg nicotine | Sham comparator | Device: Ecig 0 mg nicotineeCig 0 mg nicotine for 12 weeks |
| Nicotine free inhalator | Placebo comparator | Device: Nicotine free inhalatornicotine free inhalator for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with Major Depressive Disorder (MDD) (according to DSM 5 criteria) from throughout Sicily (Italy), who smoke tobacco cigarettes.
- smoke ≥10 factory made cig/day, for at least the past five years
- age 18-65 years
- in good general health (in absence of cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis )
- 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 (5 listed)
- use of smokeless tobacco or nicotine replacement therapy or other smoking cessation therapies
- pregnancy or breastfeeding
- current or recent (less than 1 yr) past history of alcohol and/or drug abuse
- active suicidal intention
- other significant co-morbidities according to the Investigator's clinical assessment (e.g. cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis
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 nicotineeCig 24 mg nicotine for 12 weeks | Device | eCig 24 mg nicotine |
| Ecig 0 mg nicotineeCig 0 mg nicotine for 12 weeks | Device | Ecig 0 mg nicotine |
| Nicotine free inhalatoreCig 24 mg nicotine for 12 weeks | 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.
- Background: 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 Depressed Patients, run by University of Catania at 1 site in Italy.
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 5 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.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 NCT02124187, 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.