Electronic Cigarette Use Clinical Trial
Official title:
Developing and Testing Health Warning Labels on the ENDS Device
In this project, after systematically developing electronic nicotine delivery systems (ENDS) pictorial health warning labels (HWLs), a proven clinical lab model will be used to examine and test their effect when these are placed on the ENDS device on a variety of subjective (e.g. satisfaction, harm perception, nicotine dependence, intention to quit) and objective outcomes (e.g. plasma nicotine, puff topography) in young adults.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | April 30, 2026 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 35 Years |
Eligibility | Inclusion Criteria: - Generally healthy individuals (determined by physical examination). - Age of 21-35 years. - Is willing to provide informed consent. - Is willing to attend the lab as required by the study protocol. - ENDS users (defined as using ENDS either daily or occasionally in the past 30 days) - Have abstained from ENDS use for 12 hours prior to each session. Exclusion Criteria: - Report smoking cigarettes regularly (> 5 cigarettes/month in the past year). - Report regular use of any other tobacco/nicotine product (e.g., e-cig, pipes, cigars) in the past year. - Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening). - Individuals with self-reported history of chronic disease or psychiatric conditions. - Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control). - Individuals that report current THC (marijuana) smoking/vaping. - Individuals that report the use of non-commercial (i.e., street) e-cigarette liquid or products - Individuals that report current EVALI or COVID-19 related symptoms (i.e., cough, shortness of breath, chest pain, nausea, vomiting, abdominal pain, diarrhea, fever, chills, or weight loss) - Individuals that have or have been exposed to COVID-19 in the last 14 days. |
Country | Name | City | State |
---|---|---|---|
United States | Florida International University | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida International University | University of Miami |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Heart rate | Change in heart rate, measured in beats per minute | During participants' two study visits. Heat rate will be measured from baseline continuously throughout each approximately 60-min session. | |
Other | Blood pressure | Change in blood pressure, measured in mm/hg | During participants' two study visits. Blood pressure will be measured from baseline continuously throughout each approximately 60-min session | |
Primary | Plasma nicotine | Change in plasma nicotine level | During the 2 participant visits. Blood will be taken 2 times in each ENDS use session: before and after an approximately 60-min ad lib use period | |
Secondary | Puff topography | Measurement of puffing behavior | Time Frame: During participants' two study visits. Puffing behavior is continuously measured during each ENDS use session (an approximately 60-min ad lib use period) | |
Secondary | Minnesota Nicotine Withdrawal Scale | This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0 - 100. These items are presented as Visual Analog Scale with item (measure) centered above a horizontal line anchored on the left with not at all and on the right with extremely. | During participants' 2 study visits. Questionnaire will be administered 2 times in each ENDS use session: before and after an approximately 60-min ad lib use period | |
Secondary | Tiffany-Drobes Questionnaire of Smoking Urges | This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 10 items that are scored 0 - 7. Rated on a 7-point Likert scale ranging from 0 (strongly disagree) to 6 (strongly agree). | During participants' two study visits. Questionnaire will be administered 2 times in each ENDS use session: before and after an approximately 60-min ad lib use period. | |
Secondary | Carbon monoxide levels | Change in carbon monoxide levels (in parts per million) | During participants' two study visits. Carbon monoxide levels will be measured 2 times in each ENDS use session: before and after an approximately 60-min ad lib use period | |
Secondary | Harm perception | This scale will assess waterpipe harm perception and measure perceptions of waterpipe relative risk compared to cigarettes. The scale will be scored on a 7-point scale ranging from 1 (not at all harmful), to 7 (extremely harmful). | During participants' two study visits. Questionnaire will be administered after each of the 2 ENDS use sessions. Each session is approximately 60-min ad lib use period. | |
Secondary | Duke Sensory Questionnaire | This scale will assess participants sensory experience of the inhaled product. The scale has nine items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely). | During participants' two study visits. Questionnaire will be administered after each of the 2 ENDS use sessions. Each session is approximately 60-min ad lib use period. | |
Secondary | The Cigarette/ENDS Evaluation Scale (WES) | This scale assesses participants' perception of ENDS use. The scale has 11 items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely). | During participants' two study visits. Questionnaire will be administered after each of the 2 ENDS use sessions. Each session is approximately 60-min ad lib use period. | |
Secondary | Forced expiratory volume (FEV1) | Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath.FEV is used to measure lung function. | During participants' 2 study visits. FEV tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period | |
Secondary | Forced vital capacity (FVC) | Forced vital capacity (FVC) is the maximum amount of air that can be exhaled when blowing out as fast as possible FVC is used to measure lung function. | During participants' 2 study visits. FVC tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period | |
Secondary | Peak expiratory flow (PEF) | Peak expiratory flow (PEF) is the maximal flow that can be exhaled when blowing out at a steady rate. PEF is used to measure lung function. | During participants' 2 study visits. PEF tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period | |
Secondary | Forced expiratory flow | Forced expiratory flow, also known as mid-expiratory flow; the rates at 25%, 50% and 75% FVC are given. Forced expiratory flowis used to measure lung function. | During participants' 2 study visits. Forced expiratory flow tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period |
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