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CogEcig: Cognitive Functioning and Electronic Cigarette (CogEcig)

Primary Purpose

Tobacco Abuse Smoke

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Own Brand cigarette
one high 2,4% nicotine
original 7,4 mg nicotine
nicotine free
Ego 9mg
Sponsored by
Universita degli Studi di Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tobacco Abuse Smoke

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Centro per la Prevenzione e Cura del Tabagimso

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Own Brand cigarette

One High 2,4% nicotine

Original 7,4 mg nicotine

Nicotine Free

EGO 9mg

Arm Description

Smoke Own Brand cigarette, 15 puff of cigarette.

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

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

Smoke electronic cigarette nicotine free (15 puff)

Smoke electronic cigarette EGO for a day (15 puff)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 23, 2012
Last Updated
December 17, 2012
Sponsor
Universita degli Studi di Catania
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1. Study Identification

Unique Protocol Identification Number
NCT01735487
Brief Title
CogEcig: Cognitive Functioning and Electronic Cigarette
Acronym
CogEcig
Official Title
Electronic Cigarette and Cognitive Functioning: (CogEcig)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita degli Studi di Catania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Abuse Smoke

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Own Brand cigarette
Arm Type
Active Comparator
Arm Description
Smoke Own Brand cigarette, 15 puff of cigarette.
Arm Title
One High 2,4% nicotine
Arm Type
Experimental
Arm Description
Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
Arm Title
Original 7,4 mg nicotine
Arm Type
Experimental
Arm Description
Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.
Arm Title
Nicotine Free
Arm Type
Placebo Comparator
Arm Description
Smoke electronic cigarette nicotine free (15 puff)
Arm Title
EGO 9mg
Arm Type
Experimental
Arm Description
Smoke electronic cigarette EGO for a day (15 puff)
Intervention Type
Other
Intervention Name(s)
Own Brand cigarette
Intervention Description
Smoke, 15 puff of, Own Brand cigarettes;
Intervention Type
Other
Intervention Name(s)
one high 2,4% nicotine
Other Intervention Name(s)
Categoria electronic cigarette one high 2,4% nicotine
Intervention Description
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Intervention Type
Other
Intervention Name(s)
original 7,4 mg nicotine
Other Intervention Name(s)
Categoria electronic cigarette 7,4 mg nicotine
Intervention Description
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
Intervention Type
Other
Intervention Name(s)
nicotine free
Other Intervention Name(s)
categoria electronic cigarette nicotine free "mint".
Intervention Description
smoke, 15 puff, of electronic cigarette nicotine free
Intervention Type
Other
Intervention Name(s)
Ego 9mg
Other Intervention Name(s)
electronic cigarette Ego 9 mg nicotine
Intervention Description
smoke, 15 puff, of electronic cigarette Ego 9 mg
Primary Outcome Measure Information:
Title
Cognitive Performances
Description
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.
Time Frame
35 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Centro per la Prevenzione e Cura del Tabagimso
City
Catania
ZIP/Postal Code
95124
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
28337155
Citation
Caponnetto P, Maglia M, Cannella MC, Inguscio L, Buonocore M, Scoglio C, Polosa R, Vinci V. Impact of Different e-Cigarette Generation and Models on Cognitive Performances, Craving and Gesture: A Randomized Cross-Over Trial (CogEcig). Front Psychol. 2017 Mar 9;8:127. doi: 10.3389/fpsyg.2017.00127. eCollection 2017.
Results Reference
derived

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CogEcig: Cognitive Functioning and Electronic Cigarette

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