Skip to main content
OpenTrials
Completed

NCT Number: NCT01735487

CogEcig: Cognitive Functioning and Electronic Cigarette

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tobacco Abuse Smoke

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro per la Prevenzione e Cura del Tabagimso

Catania, Italy, 95124

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Own Brand Cigarette

Other

Smoke, 15 puff of, Own Brand cigarettes;

one high 2,4% nicotine

Other

Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine

Other names: Categoria electronic cigarette one high 2,4% nicotine

original 7,4 mg nicotine

Other

Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine

Other names: Categoria electronic cigarette 7,4 mg nicotine

nicotine free

Other

smoke, 15 puff, of electronic cigarette nicotine free

Other names: categoria electronic cigarette nicotine free "mint".

Ego 9mg

Other

smoke, 15 puff, of electronic cigarette Ego 9 mg

Other names: electronic cigarette Ego 9 mg nicotine

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

Electronic Cigarette and Cognitive Functioning: (CogEcig)

Acronym: CogEcig

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 28, 2012
Registry last updated
Dec 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.