Assessing the Effect of Nicotine Reduction on ENDS User's Addiction and Exposures

NCT05205382 | Completed

• 1 other identifier: R01DA053587
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The rapid increase of electronic nicotine delivery systems (ENDS) use by young people in the US and their potential to harm health, cause addiction, and serve as a risk for cigarette smoking or dual-use is alarming. The epidemic of ENDS use among young people in the US has been associated with the rise in popularity of ENDS products that are very efficient in delivering high doses of nicotine to users. Therefore, the investigators propose to study the effects of nicotine reduction (NR) on young ENDS users as a potential regulatory strategy to reduce the addictiveness and use of ENDS. The proposed studies are directly responsive to research priories identified by the FDA and specified in this RFA under Addiction; studying the "Impact of changes in tobacco product characteristics (e.g. nicotine formulation) on dependence". This project aims to provide an overview of this project's rationale significance divided into 1) scientific rationale and regulatory implications; 2) the need to respond to the rising trend of ENDS use among young people in the US; 3) the importance of reducing the addictiveness of ENDS; 4) the strength of our clinical and analytical lab approach for regulatory purposes; and 5) the strengths and weaknesses in the rigor of prior research about NR for ENDS.

Conditions

Electronic Cigarette Use

Keywords

Nicotine reduction

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 electronic cigarette use session: before and after an approximately 60 minutes ad lib use period

Secondary Outcomes (9)

• Minnesota Nicotine Withdrawal Scale

  During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period

• Tiffany-Drobes Questionnaire of Smoking Urges

  During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period

• Carbon monoxide levels

  During participants' 2 study visits. Carbon monoxide levels will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period

• Harm perception

  During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period

• Duke Sensory Questionnaire

  During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period

Other Outcomes (2)

• Heart rate

  During participants' 2 study visits. Heat rate will be measured from baseline continuously throughout each approximately 60 minutes session

• Blood pressure

  During participants' 2 study visits. Blood pressure will be measured from baseline continuously throughout each approximately 60 minutes session

Study Arms (3)

Electronic cigarette pods (SREC or NJOY) with 5% nicotine concentration

EXPERIMENTAL

Participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods ad libitum for up to 60 minutes.

Other: 5% nicotine

Electronic cigarette pods (NJOY) with 3% nicotine concentration

EXPERIMENTAL

Participants will complete a lab visit where they will use 3% nicotine electronic cigarette pods ad libitum for up to 60 minutes.

Other: 3% nicotine

Electronic cigarette pods (SREC) with 0% nicotine concentration

EXPERIMENTAL

Participants will complete a lab visit where they will use 0% nicotine electronic cigarette pods ad libitum for up to 60 minutes.

Other: 0% nicotine

Interventions

5% nicotine OTHER

Effects of e-cigarette pods (JUUL/NJOY/SREC) with 5% nicotine concentration nicotine concentration

Electronic cigarette pods (SREC or NJOY) with 5% nicotine concentration

3% nicotine OTHER

Effects of e-cigarette pods (JUUL/NJOY) with 3% nicotine concentration

Electronic cigarette pods (NJOY) with 3% nicotine concentration

0% nicotine OTHER

Effects of e-cigarette pods (SREC) with 0% nicotine concentration

Electronic cigarette pods (SREC) with 0% nicotine concentration

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.
• Electronic cigarette users (defined as using electronic cigarette either daily or occasionally in the past 30 days)
• Have abstained from electronic cigarette 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.,hookah, 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 current 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.

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

Related Publications (1)

• Ferdous T, Roy S, Chowdhury S, Jebai R, Maya L, DeCaprio AP, Bursac Z, Maziak W. Partial Nicotine Reduction and E-Cigarette Users' Puffing Behaviors Among Adults Aged 21 to 35 Years: A Randomized Crossover Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2422954. doi: 10.1001/jamanetworkopen.2024.22954.

  PMID: 39058490 DERIVED

MeSH Terms

Conditions

Vaping

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Wasim Maziak, PhD, MD

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 25, 2022
• Study Start: April 1, 2022
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)