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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Own Brand cigarette | Active Comparator | Smoke Own Brand cigarette, 15 puff of cigarette. |
|
| One High 2,4% nicotine | Experimental | Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette. |
|
| Original 7,4 mg nicotine | Experimental | Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette. |
|
| Nicotine Free | Placebo Comparator | Smoke electronic cigarette nicotine free (15 puff) |
|
| EGO 9mg | Experimental | Smoke electronic cigarette EGO for a day (15 puff) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Own Brand cigarette | Other | Smoke, 15 puff of, Own Brand cigarettes; |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 35 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro per la Prevenzione e Cura del Tabagimso | Catania | Italy | 95124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28337155 | Derived | 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. |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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|
| one high 2,4% nicotine | Other | Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine |
|
|
| original 7,4 mg nicotine | Other | Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine |
|
|
| nicotine free | Other | smoke, 15 puff, of electronic cigarette nicotine free |
|
|
| Ego 9mg | Other | smoke, 15 puff, of electronic cigarette Ego 9 mg |
|
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |