CogEcig: Cognitive Functioning and Electronic Cigarette

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Electronic Cigarette and Cognitive Functioning: (CogEcig)

Conditions
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Tobacco Abuse Smoke

Intervention / Treatment
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* Other: Own Brand cigarette
* Other: one high 2,4% nicotine
* Other: original 7,4 mg nicotine
* Other: nicotine free
* Other: Ego 9mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Own Brand cigarette<br>Smoke Own Brand cigarette, 15 puff of cigarette. | Other: one high 2,4% nicotine<br>* Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine<br>* Other names: Categoria electronic cigarette one high 2,4% nicotine;Other: original 7,4 mg nicotine<br>* Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine<br>* Other names: Categoria electronic cigarette 7,4 mg nicotine;Other: nicotine free<br>* smoke, 15 puff, of electronic cigarette nicotine free<br>* Other names: categoria electronic cigarette nicotine free mint.;Other: Ego 9mg<br>* smoke, 15 puff, of electronic cigarette Ego 9 mg<br>* Other names: electronic cigarette Ego 9 mg nicotine;|
| Experimental: One High 2,4% nicotine<br>Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette. | Other: Own Brand cigarette<br>* Smoke, 15 puff of, Own Brand cigarettes;<br>Other: original 7,4 mg nicotine<br>* Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine<br>* Other names: Categoria electronic cigarette 7,4 mg nicotine;Other: nicotine free<br>* smoke, 15 puff, of electronic cigarette nicotine free<br>* Other names: categoria electronic cigarette nicotine free mint.;Other: Ego 9mg<br>* smoke, 15 puff, of electronic cigarette Ego 9 mg<br>* Other names: electronic cigarette Ego 9 mg nicotine;|
| Experimental: Original 7,4 mg nicotine<br>Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette. | Other: Own Brand cigarette<br>* Smoke, 15 puff of, Own Brand cigarettes;<br>Other: one high 2,4% nicotine<br>* Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine<br>* Other names: Categoria electronic cigarette one high 2,4% nicotine;Other: nicotine free<br>* smoke, 15 puff, of electronic cigarette nicotine free<br>* Other names: categoria electronic cigarette nicotine free mint.;|
| Placebo Comparator: Nicotine Free<br>Smoke electronic cigarette nicotine free (15 puff) | Other: Own Brand cigarette<br>* Smoke, 15 puff of, Own Brand cigarettes;<br>Other: one high 2,4% nicotine<br>* Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine<br>* Other names: Categoria electronic cigarette one high 2,4% nicotine;Other: original 7,4 mg nicotine<br>* Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine<br>* Other names: Categoria electronic cigarette 7,4 mg nicotine;Other: Ego 9mg<br>* smoke, 15 puff, of electronic cigarette Ego 9 mg<br>* Other names: electronic cigarette Ego 9 mg nicotine;|
| Experimental: EGO 9mg<br>Smoke electronic cigarette EGO for a day (15 puff) | Other: Own Brand cigarette<br>* Smoke, 15 puff of, Own Brand cigarettes;<br>Other: one high 2,4% nicotine<br>* Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine<br>* Other names: Categoria electronic cigarette one high 2,4% nicotine;Other: original 7,4 mg nicotine<br>* Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine<br>* Other names: Categoria electronic cigarette 7,4 mg nicotine;Other: nicotine free<br>* smoke, 15 puff, of electronic cigarette nicotine free<br>* Other names: categoria electronic cigarette nicotine free mint.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |