Developing and Testing Health Warning Labels on the ENDS Device

NCT04907136 | Recruiting

• 1 other identifier: R01DA051836
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Electronic Cigarette Use

Keywords

Health Warning Labels

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Puff topography

  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

  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

  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

  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

• Harm perception

  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.

Other Outcomes (2)

• Heart rate

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

• Blood pressure

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

Study Arms (2)

Preferred ENDS

EXPERIMENTAL

All participants will complete a lab visit where they will use their preferred ENDS ad libitum for up to 60 minutes

Other: Preferred ENDS; Other: Preferred ENDS with HWL

Preferred ENDS with HWL

EXPERIMENTAL

All participants will complete a lab visit where they will use their preferred ENDS with a HWL on the device ad libitum for up to 60 minutes

Other: Preferred ENDS; Other: Preferred ENDS with HWL

Interventions

Preferred ENDS OTHER

Preferred ENDS without HWL on device

Preferred ENDS; Preferred ENDS with HWL

Preferred ENDS with HWL OTHER

Preferred ENDS with a HWL on device

Preferred ENDS; Preferred ENDS with HWL

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Florida International University: lead
• University of Miami: collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

RECRUITING

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Wasim Maziak, MD, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wasim Maziak, MD, PhD

CONTACT

305-348-4501; wmaziak@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Epidemiology

Model Details: During this research project, HWLs will be tested on the ENDS device in a clinical lab cross-over study, where each subject uses ENDS in 2 sessions; 1) their preferred product without HWL (control), and 2) their preferred product with pictorial HWL on the ENDS device. This design will test the main study hypothesis: compared to control, using ENDS with the HWLs is associated with decreased satisfaction, dependence suppression, and puffing behavior, but increased knowledge about harm and intention to quit.

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: May 28, 2021
• Study Start: December 13, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)