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This study will examine whether nicotine levels increase with electronic cigarettes. It will also examine whether electronic cigarettes alter lung function tests. The study will obtain preliminary data on the medical effects of electronic cigarettes, with two different nicotine flavors, tobacco and tobacco with menthol, which are available for over the counter purchase.
The electronic cigarettes and juice used in this study is available for purchase through the internet. An investigational new drug application (IND) is not needed for this study.
This is a randomized two-period cross-over study in which subjects who smoke greater than 10 cigarettes will be instructed to quit smoking and use either Joye (Ego C brand) with an 18 mg cartridge containing either a tobacco or tobacco mentholated flavor for one week. Prior to starting e-cig use we will collect one blood sample for nicotine/cotinine as a measure of overall nicotine exposure. Subjects will use the device for one week and at the end of approximately one week of use, we will assess nicotine/cotinine concentrations (before and 5, 10, 15, 20 and 30 minutes after the onset of ECIG use), pulmonary function tests (before and 5 minutes after ECIG use), and subjective impressions of satisfaction. At the end of one week, subjects will be crossed over to the other condition and assessments will be repeated after another week of E-cigarette use.
A total of 30 smokers will be recruited from the surrounding areas via advertisements in newspapers and radio advertisements and University of Connecticut Health Center (UCHC) broadcast e-mail. Posters will be placed in clinical areas to recruit from physician practices. Current smokers are being proposed for three reasons: 1) we wish to determine whether nicotine levels from e-cigarettes rise to the levels of regular cigarettes when used by regular smokers; 2) we wish to determine if there are any differences seen in pulmonary function when a person switches from regular cigarettes to e-cigarettes; 3) we wish to evaluate the level of satisfaction that regular smokers have with e-cigarettes. All of these questions will have implications for later, more extensive studies of e-cigarettes, particularly in regard to their utility as a smoking cessation modality.
Once a potential study subject calls and expresses interest in the study, preliminary inclusion criteria will be assessed over the phone. Inclusion criteria include 1) at least 18 years of age; 2) current use of at least 10 cigarettes daily; 3) willing to abstain from cigarette smoking, and substitute e-cigs, for approximately 2 weeks; 4) able to read and sign a consent form; Exclusion criteria: 1) unstable medical or psychiatric disorders as determined by the principal investigator; 2) pregnancy; 3) known hypersensitivity to nicotine or propylene glycol or menthol; 4) previous myocardial infarction (M.I.) or stroke; 5) uncontrolled hypertension [Blood pressure (BP) >160/100); 6) insulin dependent diabetes; 7) known chronic obstructive pulmonary disease (COPD) or asthma.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobacco Flavor/ Tobacco & Menthol Flavor | Other | Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days. Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor (18mg/mL nicotine) |
|
| Tobacco & Menthol Flavor/Tobacco Flavor | Other | Subjects randomized to Tobacco and Menthol Flavor for 7-10 days,then crossed over to Tobacco Flavor for 7-10 days. Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor (18mg/mL nicotine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor | Drug | Subjects randomized to either Tobacco Flavor group for 7-10 days than crossed over to Tobacco & Menthol Flavor for 7-10 days or Tobacco & Menthol Flavor group for 7-10 days than crossed over to Tobacco Flavor for 7-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use | To determine the effects of acute E-cig use on venous nicotine concentrations 5 minutes before and 5 minutes after 7-10 days of e-cigarette use. | 7-10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Oncken, M.D. | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030-3940 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25762758 | Result | Oncken CA, Litt MD, McLaughlin LD, Burki NA. Nicotine concentrations with electronic cigarette use: effects of sex and flavor. Nicotine Tob Res. 2015 Apr;17(4):473-8. doi: 10.1093/ntr/ntu232. |
| Label | URL |
|---|---|
| Nicotine concentrations with electronic cigarette use: effects of sex and flavor | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tobacco Flavor/ Tobacco & Menthol Flavor | Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine |
| FG001 | Tobacco & Menthol Flavor/Tobacco Flavor | Subjects randomized to Tobacco and Menthol Flavor for 7-10 days,then crossed over to Tobacco Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 7-10 Days |
|
| |||||||||||||||||||||
| Second 7-10 Days |
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Analysis Nicotine Concentrations before ad 5 minutes after Ecig use, regardless of flavor.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine With Tobacco Flavor and With Tobacco & Menthol Flavor | Smokers were assigned to electronic cigarettes containing 18mg/mL of nicotine in either a tobacco flavor solution or a tobacco and menthol flavor solution and then switched to other flavor for an additional 7 to 10 days. Monitoring sessions occurred on the last day of trial period of each flavor. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use | To determine the effects of acute E-cig use on venous nicotine concentrations 5 minutes before and 5 minutes after 7-10 days of e-cigarette use. | Nicotine Concentrations Before and 5 Minutes After Ecig Use were intended to be analyzed, regardless of flavor, as pre-specified in the study protocol, | Posted | Mean | Standard Error | ng/ml | 7-10 days |
|
Period from Randomization to close of study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tobacco Flavor & Tobacco & Menthol Flavor (TOB Flavor) | AE occurred in intervention "Tobacco Flavor Session 17-10 days" Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thoat itchy and cough | General disorders | Systematic Assessment | HEENT ( head, ears, eyes, nose and throat) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cheryl Oncken | UConn Health | 860-679-3425 | oncken@uchc.edu |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| D062789 | Tobacco Products |
| D008610 | Menthol |
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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|
|
| time commitment |
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| concerns with using IV |
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| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | Tobacco Flavor & Tobacco & Menthol Flavor (TOB/MENTH Flavor) | AE occurred in intervention "Tobacco Flavor Session 27-10 days" Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine) | 0 | 12 | 0 | 12 |
| EG002 | Tobacco & Menthol Flavor & Tobacco Flavor (TOB/MENTH Flavor) | AE occurred in intervention "Tobacco & Menthol Flavor Session 17-10 days" Subjects randomized to Tobacco & Menthol Flavor group 7-10 days, then crossed over to Tobacco Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine) | 0 | 14 | 6 | 14 |
| EG003 | Tobacco & Menthol Flavor & Tobacco Flavor (TOB Flavor) | AE occurred in intervention "Tobacco Flavor Session 2 7-10 days" Subjects randomized to Tobacco & Menthol Flavor group 7-10 days, then crossed over to Tobacco Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco & Menthol Flavor (18mg/mL nicotine) | 0 | 8 | 2 | 8 |
|
| Concerns with using IV | Product Issues | Systematic Assessment |
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| Time Commitment | Social circumstances | Systematic Assessment |
|
| Family Emergency | Social circumstances | Systematic Assessment |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D008055 | Lipids |