CogEcig: Cognitive Functioning and Electronic Cigarette

Not Applicable

Completed

• Conditions: Tobacco Abuse Smoke
• Interventions: Other: one high 2,4% nicotine; Other: Own Brand cigarette; Other: original 7,4 mg nicotine; Other: nicotine free; Other: Ego 9mg

• Registration Number: NCT01735487
• Lead Sponsor: Universita degli Studi di Catania

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).

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2012-11
• Study First Submitted: 2012-11-23
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-28
• Status Verified: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-17
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Own Brand cigarette	one high 2,4% nicotine	Smoke Own Brand cigarette, 15 puff of cigarette.
Own Brand cigarette	original 7,4 mg nicotine	Smoke Own Brand cigarette, 15 puff of cigarette.
Own Brand cigarette	nicotine free	Smoke Own Brand cigarette, 15 puff of cigarette.
Own Brand cigarette	Ego 9mg	Smoke Own Brand cigarette, 15 puff of cigarette.
One High 2,4% nicotine	Own Brand cigarette	Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
One High 2,4% nicotine	original 7,4 mg nicotine	Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
One High 2,4% nicotine	nicotine free	Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
One High 2,4% nicotine	Ego 9mg	Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
Original 7,4 mg nicotine	Own Brand cigarette	Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.
Original 7,4 mg nicotine	one high 2,4% nicotine	Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.
Original 7,4 mg nicotine	nicotine free	Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.
Nicotine Free	Own Brand cigarette	Smoke electronic cigarette nicotine free (15 puff)
Nicotine Free	one high 2,4% nicotine	Smoke electronic cigarette nicotine free (15 puff)
Nicotine Free	original 7,4 mg nicotine	Smoke electronic cigarette nicotine free (15 puff)
Nicotine Free	Ego 9mg	Smoke electronic cigarette nicotine free (15 puff)
EGO 9mg	Own Brand cigarette	Smoke electronic cigarette EGO for a day (15 puff)
EGO 9mg	one high 2,4% nicotine	Smoke electronic cigarette EGO for a day (15 puff)
EGO 9mg	original 7,4 mg nicotine	Smoke electronic cigarette EGO for a day (15 puff)
EGO 9mg	nicotine free	Smoke electronic cigarette EGO for a day (15 puff)

Primary Outcome Measures

Name	Time	Method
Cognitive Performances	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.

Trial Locations

Locations (1)

Centro per la Prevenzione e Cura del Tabagimso; 🇮🇹 Catania, Italy