CogEcig: Cognitive Functioning and Electronic Cigarette

Universita degli Studi di Catania

Status: Completed

Conditions: Tobacco Abuse Smoke

Treatments: Other: Own Brand cigarette; Other: one high 2,4% nicotine; Other: Ego 9mg; Other: nicotine free; Other: original 7,4 mg nicotine

Study type: Interventional

Funder types: Other

Identifiers

NCT01735487

CogEcig

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 5 patient groups, including a placebo group

Own Brand cigarette

Active Comparator group

Description:

Smoke Own Brand cigarette, 15 puff of cigarette.

Treatment:

Other: original 7,4 mg nicotine

Other: nicotine free

Other: Ego 9mg

Other: one high 2,4% nicotine

One High 2,4% nicotine

Experimental group

Description:

Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.

Treatment:

Other: original 7,4 mg nicotine

Other: nicotine free

Other: Ego 9mg

Other: Own Brand cigarette

Original 7,4 mg nicotine

Experimental group

Description:

Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.

Treatment:

Other: nicotine free

Other: one high 2,4% nicotine

Other: Own Brand cigarette

Nicotine Free

Placebo Comparator group

Description:

Smoke electronic cigarette nicotine free (15 puff)

Treatment:

Other: original 7,4 mg nicotine

Other: Ego 9mg

Other: one high 2,4% nicotine

Other: Own Brand cigarette

EGO 9mg

Experimental group

Description:

Smoke electronic cigarette EGO for a day (15 puff)

Treatment:

Other: original 7,4 mg nicotine

Other: nicotine free

Other: one high 2,4% nicotine

Other: Own Brand cigarette