Developing and Testing Health Warning Labels on the ENDS Device

ConditionElectronic Cigarette Use

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-35

SponsorFlorida International University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

Preferred ENDS
Other intervention
Preferred ENDS without HWL on device
Preferred ENDS with HWL
Other intervention
Preferred ENDS with a HWL on device

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Preferred ENDSExperimental treatment 2 interventions

Group B: Preferred ENDS with HWLExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Plasma nicotine

Change in plasma nicotine level

Time frame

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 outcomes

Puff topography

Measurement of puffing behavior

Time frame

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)

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.

Time frame

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

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).

Time frame

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.

Carbon monoxide levels

Change in carbon monoxide levels (in parts per million)

Time frame

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

Other outcomes

Heart rate

Change in heart rate, measured in beats per minute

Time frame

During participants' two study visits. Heat rate will be measured from baseline continuously throughout each approximately 60-min session.

Blood pressure

Change in blood pressure, measured in mm/hg

Time frame

During participants' two study visits. Blood pressure will be measured from baseline continuously throughout each approximately 60-min session

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida International University

Lead sponsor

University of Miami

Collaborator

Source ClinicalTrials.gov

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