Clinical trial NCT01735487: CogEcig: Cognitive Functioning and Electronic Cigarette
Official title: Electronic Cigarette and Cognitive Functioning: (CogEcig)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Abuse Smoke
Lead sponsor: Universita degli Studi di Catania
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Performances
timeFrame: 35 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Centro per la Prevenzione e Cura del Tabagimso
Study officials:
References:
citation: 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.