NCT01735487

CogEcig: Cognitive Functioning and Electronic Cigarette

Electronic Cigarette and Cognitive Functioning: (CogEcig)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Universita degli Studi di Catania · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Tobacco Abuse Smoke

Interventions

Type	Name	Description
OTHER	Own Brand cigarette	Smoke, 15 puff of, Own Brand cigarettes;
OTHER	one high 2,4% nicotine	Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
OTHER	original 7,4 mg nicotine	Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
OTHER	nicotine free	smoke, 15 puff, of electronic cigarette nicotine free
OTHER	Ego 9mg	smoke, 15 puff, of electronic cigarette Ego 9 mg

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2012-11-28
• Last updated: 2012-12-18

Locations

1 site across 1 country: Italy