CogEcig: Cognitive Functioning and Electronic Cigarette

Tobacco Abuse Smoke Clinical Trial

— CogEcig  

Official title:

Electronic Cigarette and Cognitive Functioning: (CogEcig)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735487
• Other study ID #: CogEcig
• Status: Completed
• Phase: N/A
• First received: November 23, 2012
• Last updated: December 17, 2012
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Universita degli Studi di Catania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tobacco Abuse Smoke
• Tobacco Use Disorder

Intervention

Other:
• Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
• one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
• original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
• nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
• Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg

Locations

Country	Name	City	State
Italy	Centro per la Prevenzione e Cura del Tabagimso	Catania

Sponsors (1)

Lead Sponsor	Collaborator
Universita degli Studi di Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No