CogEcig: Cognitive Functioning and Electronic Cigarette

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Riccardo Polosa, Universita degli Studi di Catania
ClinicalTrials.gov Identifier:
NCT01735487
First received: November 23, 2012
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Tobacco Abuse Smoke
Other: Own Brand cigarette
Other: one high 2,4% nicotine
Other: original 7,4 mg nicotine
Other: nicotine free
Other: Ego 9mg

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Electronic Cigarette and Cognitive Functioning: (CogEcig)

Resource links provided by NLM:


Further study details as provided by Universita degli Studi di Catania:

Primary Outcome Measures:
  • Cognitive Performances [ Time Frame: 35 minutes ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Own Brand cigarette
Smoke Own Brand cigarette, 15 puff of cigarette.
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Name: Categoria 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 Name: Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Name: categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Name: electronic cigarette Ego 9 mg nicotine
Experimental: One High 2,4% nicotine
Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other Name: Own Brand cigarette
Other: original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
Other Name: Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Name: categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Name: electronic cigarette Ego 9 mg nicotine
Experimental: Original 7,4 mg nicotine
Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.
Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other Name: Own Brand cigarette
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Name: Categoria electronic cigarette one high 2,4% nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Name: categoria electronic cigarette nicotine free "mint".
Placebo Comparator: Nicotine Free
Smoke electronic cigarette nicotine free (15 puff)
Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other Name: Own Brand cigarette
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Name: Categoria 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 Name: Categoria electronic cigarette 7,4 mg nicotine
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Name: electronic cigarette Ego 9 mg nicotine
Experimental: EGO 9mg
Smoke electronic cigarette EGO for a day (15 puff)
Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other Name: Own Brand cigarette
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Name: Categoria 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 Name: Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Name: categoria electronic cigarette nicotine free "mint".

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735487

Locations
Italy
Centro per la Prevenzione e Cura del Tabagimso
Catania, Italy, 95124
Sponsors and Collaborators
Universita degli Studi di Catania
  More Information

No publications provided

Responsible Party: Riccardo Polosa, Professor, Universita degli Studi di Catania
ClinicalTrials.gov Identifier: NCT01735487     History of Changes
Other Study ID Numbers: CogEcig
Study First Received: November 23, 2012
Last Updated: December 17, 2012
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014