Tobacco Abuse SmokeCogEcigNCT01735487
CogEcig: Cognitive Functioning and Electronic Cigarette
A study testing Own Brand cigarette, one high 2,4% nicotine and original 7,4 mg nicotine in people with Tobacco Abuse Smoke, run by University of Catania at 1 site in Italy.
Trial summary
The aim of the present study is to compare cognitive scores (attention, executive function and working memory) of different e-Cigarette strength with usual cigarettes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Abuse Smoke
- What is being tested?
- Own Brand cigarette, one high 2,4% nicotine and original 7,4 mg nicotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2012to Dec 2012
- 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
- 20 regular smokers (smoking ≥ 15 factory-made cigarettes per day for at least the past 10 years and not currently attempting to quit smoking or wishing to do so in the next 30 days, CO > 10 parts per million ) will be recruited from the local Hospital staff in Catania, Italy.
Who cannot join
- people who reported recent myocardial infarction, angina pectoris or other serious medical conditions (diabetes mellitus, severe allergies, poorly controlled asthma or other airways disease, poorly controlled psychiatric disorders or current chemical dependence other than nicotine) and
- pregnancy,
- breastfeeding,
- blood pressure > 180 mm Hg systolic and/or 100 mm Hg diastolic,
- weight < 45 or > 120 kg, or
- current use of any other smoking cessation medications
Trial locations and contacts
1 site in 1 country.
Italy1 site
Centro per la Prevenzione e Cura del Tabagimso
Catania, Italy, 95124
About this study
Official title: Electronic Cigarette and Cognitive Functioning: (CogEcig)
The aim of the present study is to compare cognitive scores (attention, executive function and working memory) of different e-Cigarette strength with usual cigarettes.
Read the detailed description
The study is randomised cross-over trial designed to compare: 1) Cognitive performances levels for four different e-Cigarette strength. Participants will be requested to abstain from smoking and alcohol from 20:00 on the night before each study day and from food and caffeine for at least 1 h before the session. On arrival at the study centre, carbon monoxide (CO) will be measured in participants' expired breath. If CO will be >15 parts per million (ppm), the assigned study treatment will be allocated; however, if CO was >15 ppm or they will report smoking in the previous 12 h, participants will be rescheduled wherever possible to a subsequent session.
On the first study day, participants will be randomised to use one of five ordered conditions: Electronic Nicotine Delivery Device (ENDD) (fourth generation) containing nicotine 2,4%; Electronic Nicotine Delivery Device (ENDD (second generation) containing nicotine 7,4 mg; Electronic Nicotine Delivery Device (ENDD containing nicotine 9 mg; Electronic Nicotine Delivery Device (ENDD nicotine free; their usual cigarette. Additionally participants will be trained to use an electronic cigarette. The following tests will be completed at the each visits: Continuous Performance Test - AX version (CPT-AX), Wisconsin card sorting test( WCST), Working memory test (N-BACK).
- Conditions
- Tobacco Abuse Smoke
- Being tested
- Own Brand cigarette, one high 2,4% nicotine, original 7,4 mg nicotine, nicotine free, Ego 9mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Own Brand cigaretteOther
Smoke, 15 puff of, Own Brand cigarettes;
one high 2,4% nicotineOther
Also called Categoria electronic cigarette one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
original 7,4 mg nicotineOther
Also called Categoria electronic cigarette 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
nicotine freeOther
Also called categoria electronic cigarette nicotine free "mint".
smoke, 15 puff, of electronic cigarette nicotine free
Ego 9mgOther
Also called electronic cigarette Ego 9 mg nicotine
smoke, 15 puff, of electronic cigarette Ego 9 mg
| Study group | Role | What they receive |
|---|---|---|
| Own Brand cigarette | Active comparator | Smoke Own Brand cigarette, 15 puff of cigarette. Receives: Other: one high 2,4% nicotine; Other: original 7,4 mg nicotine; Other: nicotine free; Other: Ego 9mg |
| One High 2,4% nicotine | Experimental | Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette. Receives: Other: Own Brand cigarette; Other: original 7,4 mg nicotine; Other: nicotine free; Other: Ego 9mg |
| Original 7,4 mg nicotine | Experimental | Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette. Receives: Other: Own Brand cigarette; Other: one high 2,4% nicotine; Other: nicotine free |
| Nicotine Free | Placebo comparator | Smoke electronic cigarette nicotine free (15 puff) Receives: Other: Own Brand cigarette; Other: one high 2,4% nicotine; Other: original 7,4 mg nicotine; Other: Ego 9mg |
| EGO 9mg | Experimental | Smoke electronic cigarette EGO for a day (15 puff) Receives: Other: Own Brand cigarette; Other: one high 2,4% nicotine; Other: original 7,4 mg nicotine; Other: nicotine free |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Performances
Compare cognitive performances in subjects who smoke "Categoria" electronic cigarettes labelled Original 7,4 mg nicotine , "Categoria" electronic cigarettes labelled One 2,4% nicotine, "Categoria" electronic cigarettes labelled "Mint" nicotine free, electronic cigarettes labelled Ego 9 mg nicotine with usual cigarettes.
Measured: 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionDec 2012
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 Abuse SmokeStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735487
- Sponsor's protocol ID
- CogEcig
- Acronym
- CogEcig
- Status last verified
- Dec 2012
- First submitted
- 23 Nov 2012
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Caponnetto P, Maglia M, Cannella MC, Inguscio L, Buonocore M, Scoglio C, Polosa R, Vinci V. Impact of Different e-Cigarette Generation and Models on Cognitive Performances, Craving and Gesture: A Randomized Cross-Over Trial (CogEcig). Front Psychol. 2017 Mar 9;8:127. doi: 10.3389/fpsyg.2017.00127. eCollection 2017.
PubMed 28337155
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Cigarette and Cognitive Functioning: (CogEcig)
- ClinicalTrials.gov ID
- NCT01735487
- Acronym / sponsor ID
- CogEcig / CogEcig
- Conditions
- Tobacco Abuse Smoke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Nov 2012 (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.
The aim of the present study is to compare cognitive scores (attention, executive function and working memory) of different e-Cigarette strength with usual cigarettes.
Detailed description
The study is randomised cross-over trial designed to compare: 1) Cognitive performances levels for four different e-Cigarette strength. Participants will be requested to abstain from smoking and alcohol from 20:00 on the night before each study day and from food and caffeine for at least 1 h before the session. On arrival at the study centre, carbon monoxide (CO) will be measured in participants' expired breath. If CO will be >15 parts per million (ppm), the assigned study treatment will be allocated; however, if CO was >15 ppm or they will report smoking in the previous 12 h, participants will be rescheduled wherever possible to a subsequent session.
On the first study day, participants will be randomised to use one of five ordered conditions: Electronic Nicotine Delivery Device (ENDD) (fourth generation) containing nicotine 2,4%; Electronic Nicotine Delivery Device (ENDD (second generation) containing nicotine 7,4 mg; Electronic Nicotine Delivery Device (ENDD containing nicotine 9 mg; Electronic Nicotine Delivery Device (ENDD nicotine free; their usual cigarette. Additionally participants will be trained to use an electronic cigarette. The following tests will be completed at the each visits: Continuous Performance Test - AX version (CPT-AX), Wisconsin card sorting test( WCST), Working memory test (N-BACK).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Own Brand cigarette | Active comparator | Other: one high 2,4% nicotine, Other: original 7,4 mg nicotine, Other: nicotine free, Other: Ego 9mgSmoke Own Brand cigarette, 15 puff of cigarette. |
| One High 2,4% nicotine | Experimental | Other: Own Brand cigarette, Other: original 7,4 mg nicotine, Other: nicotine free, Other: Ego 9mgSmoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette. |
| Original 7,4 mg nicotine | Experimental | Other: Own Brand cigarette, Other: one high 2,4% nicotine, Other: nicotine freeSmoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette. |
| Nicotine Free | Placebo comparator | Other: Own Brand cigarette, Other: one high 2,4% nicotine, Other: original 7,4 mg nicotine, Other: Ego 9mgSmoke electronic cigarette nicotine free (15 puff) |
| EGO 9mg | Experimental | Other: Own Brand cigarette, Other: one high 2,4% nicotine, Other: original 7,4 mg nicotine, Other: nicotine freeSmoke electronic cigarette EGO for a day (15 puff) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20 regular smokers (smoking ≥ 15 factory-made cigarettes per day for at least the past 10 years and not currently attempting to quit smoking or wishing to do so in the next 30 days, CO > 10 parts per million ) will be recruited from the local Hospital staff in Catania, Italy.
Key exclusion criteria (6 listed)
- people who reported recent myocardial infarction, angina pectoris or other serious medical conditions (diabetes mellitus, severe allergies, poorly controlled asthma or other airways disease, poorly controlled psychiatric disorders or current chemical dependence other than nicotine) and
- pregnancy,
- breastfeeding,
- blood pressure > 180 mm Hg systolic and/or 100 mm Hg diastolic,
- weight < 45 or > 120 kg, or
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 |
|---|---|---|
| Own Brand cigaretteSmoke, 15 puff of, Own Brand cigarettes; | Other | EGO 9mg, Nicotine Free, One High 2,4% nicotine, Original 7,4 mg nicotine |
| one high 2,4% nicotineAlso: Categoria electronic cigarette one high 2,4% nicotineSmoke, 25 puff, of electronic cigarette one high 2,4% nicotine | Other | EGO 9mg, Nicotine Free, Original 7,4 mg nicotine, Own Brand cigarette |
| original 7,4 mg nicotineAlso: Categoria electronic cigarette 7,4 mg nicotineSmoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine | Other | EGO 9mg, Nicotine Free, One High 2,4% nicotine, Own Brand cigarette |
| nicotine freeAlso: categoria electronic cigarette nicotine free "mint".smoke, 15 puff, of electronic cigarette nicotine free | Other | EGO 9mg, One High 2,4% nicotine, Original 7,4 mg nicotine, Own Brand cigarette |
| Ego 9mgAlso: electronic cigarette Ego 9 mg nicotinesmoke, 15 puff, of electronic cigarette Ego 9 mg | Other | Nicotine Free, One High 2,4% nicotine, Own Brand cigarette |
Primary outcome
Cognitive Performances
Time frame: 35 minutes
Compare cognitive performances in subjects who smoke "Categoria" electronic cigarettes labelled Original 7,4 mg nicotine , "Categoria" electronic cigarettes labelled One 2,4% nicotine, "Categoria" electronic cigarettes labelled "Mint" nicotine free, electronic cigarettes labelled Ego 9 mg nicotine with usual cigarettes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
- Derived from this study: PubMed 28337155Caponnetto P, Maglia M, Cannella MC, Inguscio L, Buonocore M, Scoglio C, Polosa R, Vinci V. Impact of Different e-Cigarette Generation and Models on Cognitive Performances, Craving and Gesture: A Randomized Cross-Over Trial (CogEcig). Front Psychol. 2017 Mar 9;8:127. doi: 10.3389/fpsyg.2017.00127. eCollection 2017.
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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 Own Brand cigarette, one high 2,4% nicotine and original 7,4 mg nicotine in people with Tobacco Abuse Smoke, 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 18 Dec 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive Performances (time frame: 35 minutes). 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 NCT01735487, 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 18 Dec 2012.