CogEcig: Cognitive Functioning and Electronic Cigarette (CogEcig)

December 17, 2012 updated by: Riccardo Polosa, Universita degli Studi di Catania

Electronic Cigarette and Cognitive Functioning: (CogEcig)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy, 95124
        • Centro per la Prevenzione e Cura del Tabagimso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Names:
  • 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: original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
Other Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Names:
  • 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: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Names:
  • Categoria electronic cigarette one high 2,4% nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • 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: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Names:
  • 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 Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Names:
  • 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: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Names:
  • 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 Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • categoria electronic cigarette nicotine free "mint".

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cognitive Performances
Time Frame: 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.
35 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universita degli Studi di Catania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CogEcig

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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