Electronic Cigarette UseNCT05205382
Assessing the Effect of Nicotine Reduction on ENDS User's Addiction and Exposures
A study testing 5% nicotine (Partial Nicotine Reduction), 3% or 2.4% nicotine (Partial Nicotine Reduction) and 5% nicotine (Total Nicotine Reduction) in people with Electronic Cigarette Use, run by Florida International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use
- What is being tested?
- 5% nicotine (Partial Nicotine Reduction), 3% or 2.4% nicotine (Partial Nicotine Reduction) and 5% nicotine (Total Nicotine Reduction)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
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.
Read the detailed description
The use of electronic nicotine delivery systems (ENDS or e-cigarettes) has reached epidemic levels among young people in the United States (US). ENDS emit toxic substances, including nicotine that irreversibly affects the developing brain and leads to dependence and increased risk of cigarette smoking initiation. Evidence indicates that young people using ENDS are likely to accelerate use and become nicotine dependent. Some of the most popular ENDS among youth (e.g. JUUL with 5% nicotine liquid) deliver in one cartridge a nicotine dose equal to an entire pack of cigarettes, and many users are unaware of this substantial exposure and the related risk of addiction. On the other hand, nicotine reduction (NR) has been considered by the US Food and Drug Administration (FDA) as an important strategy to limit the addictiveness and use of tobacco products.
Now that the FDA regulates ENDS under the "deeming rule", such a strategy can be considered for these emerging tobacco products. However, the investigators still lack evidence on the expected effects of a range of NR levels on ENDS users at different stages of use trajectory. Using clinical and analytical lab methods, the investigators plan to compare among 5% nicotine ENDS users the effect of partial (3%/2.4%) or total (nicotine-free, 0%) NR on users' dependence, satisfaction, clinical (e.g. BP, oximetry, lung functions, symptoms), puffing behavior, and exposure to toxicants. The investigators will recruit current ENDS users (n=120; 21-35 yrs), for a 2X2 within subject crossover lab study. The nicotine conditions (5%, 3%/2.4%) or (0%,5%) x 2 times (pre-post) are the within-subject factors.
Therefore, the study is divided into 2 parts, whereby the first part will be 2x2 comparing JUUL/NJOY 5% and 3%/2.4% to test the effects of partial nicotine reduction, and the second part will be using the NIDA Standardized Research Electronic Cigarette (SREC) for Clinical Research 5% and 0% (placebo), to test the effect of the total reduction using the same pods and juices from the same manufacturer.
The investigators hypothesize that NR will be associated with less satisfaction, withdrawal suppression, and intention to use and that such an effect will be more pronounced in total compared to partial NR and among high compared to low-dependency users. The proposed studies aim to answer 3 main regulatory questions: 1) is NR a promising regulatory option to reduce ENDS addictiveness and use; 2) what is the effect of partial vs. total NR on compensatory puffing and exposure to nicotine and respiratory toxicants, and 3) what is the effect of NR on ENDS users at different stages of their use. Combined, these studies will give direct and standardized evidence on the potential of NR regulations to limit the addictiveness and use of ENDS, and to help predict any potential side effects of NR on ENDS users' exposure to harmful toxicants.
- Conditions
- Electronic Cigarette Use
- Being tested
- 5% nicotine (Partial Nicotine Reduction), 3% or 2.4% nicotine (Partial Nicotine Reduction), 5% nicotine (Total Nicotine Reduction), 0% nicotine (Total Nicotine Reduction)
- Keywords
- Nicotine reduction
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% nicotine (Partial Nicotine Reduction)Other
Partial Nicotine Reduction: Effects of e-cigarette pods (JUUL/NJOY) with 5% nicotine concentration nicotine concentration
3% or 2.4% nicotine (Partial Nicotine Reduction)Other
Partial Nicotine Reduction: Effects of e-cigarette pods (JUUL/NJOY) with 3% or 2.4% nicotine concentration
5% nicotine (Total Nicotine Reduction)Other
Total Nicotine Reduction: Effects of e-cigarette pods (SREC) with 5% nicotine concentration
0% nicotine (Total Nicotine Reduction)Other
Total Nicotine Reduction: Effects of e-cigarette pods (SREC) with 0% nicotine concentration nicotine concentration
| Study group | Role | What they receive |
|---|---|---|
| Partial Nicotine Reduction: Electronic cigarette pods with 5% nicotine concentration | Experimental | For the partial nicotine reduction study, participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods (JUUL/NJOY) ad libitum for up to 60 minutes. Receives: Other: 5% nicotine (Partial Nicotine Reduction) |
| Partial Nicotine Reduction: Electronic cigarette pods with 3% or 2.4% nicotine concentration | Experimental | For the partial nicotine reduction study, participants will complete a lab visit where they will use 3% or 2.4% nicotine electronic cigarette pods (JUUL/NJOY) ad libitum for up to 60 minutes. Receives: Other: 3% or 2.4% nicotine (Partial Nicotine Reduction) |
| Total Nicotine Reduction: Electronic cigarette pods with 5% nicotine concentration | Experimental | For the total nicotine reduction study, participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods (SREC) ad libitum for up to 60 minutes. Receives: Other: 5% nicotine (Total Nicotine Reduction) |
| Total Nicotine Reduction: Electronic cigarette pods with 0% nicotine concentration | Experimental | For the total nicotine reduction study, participants will complete a lab visit where they will use 0% nicotine electronic cigarette pods (SREC) ad libitum for up to 60 minutes. Receives: Other: 0% nicotine (Total Nicotine Reduction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Nicotine Boost
Change in plasma nicotine level. The plasma nicotine boost was calculated by subtracting the preplasma nicotine value from the postplasma value.
Measured: During the 2 participant visits, blood was taken 2 times in each session: before and after approximately 60 minutes ad lib use.
Secondary outcomes (13)
Puff Topography (Total Puffing Time)
Measurement of puffing behavior in total puffing time
Measured: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
Puff Topography (Average Puff Duration)
Measurement of puffing behavior in average puffing duration
Measured: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
Puff Topography (Puff Number)
Measurement of puffing behavior; mean of the number of puffs taken during the ad-libitum smoking session
Measured: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
Puff Topography (Inhaled Volume)
Measurement of puffing behavior; mean volume of puffs inhaled during the ad-libitum smoking session
Measured: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
Toxicants (Carcinogenic and Probably or Possibly Carcinogenic) Exposure
This aim elucidates how compensatory puffing behavior in response to NR affects exposure to pulmonary toxicants. The analytical assessments were conducted at the AUB Aerosol Research Laboratory (ARL) using the Aerosol Lab Vaping Instrument (ALVIN). The ALVIN is programmed to playback participants' puffing behavior recorded during their two sessions (for both partial and total nicotine reduction studies) to generate and sample the e-cigarette aerosol for analysis. The ARL is equipped with gas chromatographs with a flame ionization detector and a mass spectrometer (GC-FID, GC-MS), as well as and High-performance liquid chromatography Mass Spectrometry (HPLC-MS) for aldehydes analysis. ARL optimized analytical methods have been used in several NIH-funded studies of ENDS nicotine and aldehydes emissions.
Measured: During the 2 participant visits for both trials (partial and total). Toxicant exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
TPM (Total Particular Matter) Exposure
This aim elucidates how compensatory puffing behavior in response to NR affects exposure to pulmonary toxicants. The analytical assessments were conducted at the AUB Aerosol Research Laboratory (ARL) using the Aerosol Lab Vaping Instrument (ALVIN). The ALVIN is programmed to playback participants' puffing behavior recorded during their two sessions (for both partial and total nicotine reduction studies) to generate and sample the e-cigarette aerosol for analysis. The ARL is equipped with gas chromatographs with a flame ionization detector and a mass spectrometer (GC-FID, GC-MS), as well as and High-performance liquid chromatography Mass Spectrometry (HPLC-MS) for aldehydes analysis. ARL optimized analytical methods have been used in several NIH-funded studies of ENDS nicotine and aldehydes emissions.
Measured: During the 2 participant visits for both trials (partial and total). Total Particular Matter exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
Lung Function Tests (LFTs) Change
LFTs (i.e., lung volume testing, airway resistance, specific airway conductance) will be measured before and immediately after ENDS use. According to 2019 American Thoracic Society and European Respiratory Society recommendation simple spirometry (e.g., change in FVC and FEV1) will be performed. Note: This outcome is not involved in multiple assessments since all the values will appear on the spirometry at the same time.
Measured: During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
Lung Function Tests (LFTs) (% Predicted Change)
LFTs (i.e., lung volume testing, airway resistance, specific airway conductance) will be measured before and immediately after ENDS use. According to 2019 American Thoracic Society and European Respiratory Society recommendation simple spirometry (e.g., % predicted value pred (FVC), FEV1 % pred FEV1/FVC, % pred) will be performed. Note: This outcome is not involved in multiple assessments since all the values will appear on the spirometry at the same time.
Measured: During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
Minnesota Nicotine Withdrawal Scale (MNWS)
Nicotine withdrawal symptoms were measured using the Minnesota Nicotine Withdrawal Scale (MNWS) before and after each vaping session. MNWS evaluates 11 withdrawal-related symptoms, including depressed mood, irritability, restlessness, hunger, and difficulty concentrating, using scale from "0" (not at all) to "100" (extremely). For each session and condition, change scores were calculated by subtracting pre-session from post-session scores for each individual item
Measured: 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 (QSU)
The Tiffany-Drobes Questionnaire of Smoking Urges-Brief (QSU-Brief) is a 10-item self-report measure of cigarette craving and urge to smoke. It consists of two subscales representing distinct dimensions of craving:
Factor 1 (Desire and Intention to Smoke): assesses desire, intention, and anticipation of pleasure associated with smoking.
Factor 2 (Anticipation of Relief from Negative Affect and Withdrawal): assesses expectations that smoking will relieve withdrawal symptoms or negative affect.
Each item is rated on a 7-point Likert scale ranging from 1 = strongly disagree to 7 = strongly agree. Subscale scores were calculated by averaging the items within each factor. Higher scores on either factor indicate greater smoking urge or craving, representing a worse outcome, whereas lower scores indicate lower craving or urge to smoke, representing a better outcome. Pre- to post-session change scores were calculated as pre-session score minus post-session score for each factor.
Measured: 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
Duke Sensory Questionnaire (DSQ)
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).
Measured: 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
Modified Cigarette Evaluation Questionnaire (mCEQ)
Modified Cigarette Evaluation Questionnaire (mCEQ) is used to assess subjective effects associated with ENDS use. The 11-item questionnaire evaluates satisfaction, psychological reward, enjoyment of respiratory tract sensations, craving reduction and aversion. Individual item scores were reported (not subscales). Each item was rated using 7-point Likert scale; 1 = not at all to 7 = extremely. For all items, higher scores indicate greater endorsement of the measured subjective experience, while lower scores indicate less endorsement of that experience. The interpretation depends on the construct being measured:
For items assessing satisfaction, enjoyment, psychological reward, sensory experiences, and craving reduction, higher scores indicate greater product reinforcement or abuse liability. For items assessing aversion, higher scores indicate greater unpleasant effects or product aversiveness.
Measured: 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
Visual Analogue Scale (VAS)
This scale contains 10-item questions to assess users' pleasure and enjoyment using the validated Visual Analog Scale (VAS) post ENDS use sessions. The scale includes items to assess user's desire, pleasure, satisfaction, future use, and other information rated on an analog scale (0 not at all to 100 extremely).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Apr 2022
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wasim Maziak, PhD, MD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205382
- Sponsor's protocol ID
- R01DA053587
- Status last verified
- Sep 2025
- First submitted
- 15 Dec 2021
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roy S, Chowdhury S, Ferdous T, Shihadeh A, Salman R, El Hage R, Salam S, Bursac Z, Maziak W. Predicting nicotine emissions and plasma nicotine boost in E-cigarette users using machine learning. Sci Rep. 2026 Jun 13. doi: 10.1038/s41598-026-57341-4. Online ahead of print.
PubMed 42288659Ferdous 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.
PubMed 39058490
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Nicotine Reduction on ENDS User's Addiction and Exposures
- ClinicalTrials.gov ID
- NCT05205382
- Acronym / sponsor ID
- R01DA053587
- Conditions
- Electronic Cigarette Use
- Keywords
- Nicotine reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The use of electronic nicotine delivery systems (ENDS or e-cigarettes) has reached epidemic levels among young people in the United States (US). ENDS emit toxic substances, including nicotine that irreversibly affects the developing brain and leads to dependence and increased risk of cigarette smoking initiation. Evidence indicates that young people using ENDS are likely to accelerate use and become nicotine dependent. Some of the most popular ENDS among youth (e.g. JUUL with 5% nicotine liquid) deliver in one cartridge a nicotine dose equal to an entire pack of cigarettes, and many users are unaware of this substantial exposure and the related risk of addiction. On the other hand, nicotine reduction (NR) has been considered by the US Food and Drug Administration (FDA) as an important strategy to limit the addictiveness and use of tobacco products.
Now that the FDA regulates ENDS under the "deeming rule", such a strategy can be considered for these emerging tobacco products. However, the investigators still lack evidence on the expected effects of a range of NR levels on ENDS users at different stages of use trajectory. Using clinical and analytical lab methods, the investigators plan to compare among 5% nicotine ENDS users the effect of partial (3%/2.4%) or total (nicotine-free, 0%) NR on users' dependence, satisfaction, clinical (e.g. BP, oximetry, lung functions, symptoms), puffing behavior, and exposure to toxicants. The investigators will recruit current ENDS users (n=120; 21-35 yrs), for a 2X2 within subject crossover lab study. The nicotine conditions (5%, 3%/2.4%) or (0%,5%) x 2 times (pre-post) are the within-subject factors.
Therefore, the study is divided into 2 parts, whereby the first part will be 2x2 comparing JUUL/NJOY 5% and 3%/2.4% to test the effects of partial nicotine reduction, and the second part will be using the NIDA Standardized Research Electronic Cigarette (SREC) for Clinical Research 5% and 0% (placebo), to test the effect of the total reduction using the same pods and juices from the same manufacturer.
The investigators hypothesize that NR will be associated with less satisfaction, withdrawal suppression, and intention to use and that such an effect will be more pronounced in total compared to partial NR and among high compared to low-dependency users. The proposed studies aim to answer 3 main regulatory questions: 1) is NR a promising regulatory option to reduce ENDS addictiveness and use; 2) what is the effect of partial vs. total NR on compensatory puffing and exposure to nicotine and respiratory toxicants, and 3) what is the effect of NR on ENDS users at different stages of their use. Combined, these studies will give direct and standardized evidence on the potential of NR regulations to limit the addictiveness and use of ENDS, and to help predict any potential side effects of NR on ENDS users' exposure to harmful toxicants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Partial Nicotine Reduction: Electronic cigarette pods with 5% nicotine concentration | Experimental | Other: 5% nicotine (Partial Nicotine Reduction)For the partial nicotine reduction study, participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods (JUUL/NJOY) ad libitum for up to 60 minutes. |
| Partial Nicotine Reduction: Electronic cigarette pods with 3% or 2.4% nicotine concentration | Experimental | Other: 3% or 2.4% nicotine (Partial Nicotine Reduction)For the partial nicotine reduction study, participants will complete a lab visit where they will use 3% or 2.4% nicotine electronic cigarette pods (JUUL/NJOY) ad libitum for up to 60 minutes. |
| Total Nicotine Reduction: Electronic cigarette pods with 5% nicotine concentration | Experimental | Other: 5% nicotine (Total Nicotine Reduction)For the total nicotine reduction study, participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods (SREC) ad libitum for up to 60 minutes. |
| Total Nicotine Reduction: Electronic cigarette pods with 0% nicotine concentration | Experimental | Other: 0% nicotine (Total Nicotine Reduction)For the total nicotine reduction study, participants will complete a lab visit where they will use 0% nicotine electronic cigarette pods (SREC) ad libitum for up to 60 minutes. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% nicotine (Partial Nicotine Reduction)Partial Nicotine Reduction: Effects of e-cigarette pods (JUUL/NJOY) with 5% nicotine concentration nicotine concentration | Other | Partial Nicotine Reduction: Electronic cigarette pods with 5% nicotine concentration |
| 3% or 2.4% nicotine (Partial Nicotine Reduction)Partial Nicotine Reduction: Effects of e-cigarette pods (JUUL/NJOY) with 3% or 2.4% nicotine concentration | Other | Partial Nicotine Reduction: Electronic cigarette pods with 3% or 2.4% nicotine concentration |
| 5% nicotine (Total Nicotine Reduction)Total Nicotine Reduction: Effects of e-cigarette pods (SREC) with 5% nicotine concentration | Other | Total Nicotine Reduction: Electronic cigarette pods with 5% nicotine concentration |
| 0% nicotine (Total Nicotine Reduction)Total Nicotine Reduction: Effects of e-cigarette pods (SREC) with 0% nicotine concentration nicotine concentration | Other | Total Nicotine Reduction: Electronic cigarette pods with 0% nicotine concentration |
Primary outcome
Plasma Nicotine Boost
Time frame: During the 2 participant visits, blood was taken 2 times in each session: before and after approximately 60 minutes ad lib use.
Change in plasma nicotine level. The plasma nicotine boost was calculated by subtracting the preplasma nicotine value from the postplasma value.
13 secondary outcomes
Puff Topography (Total Puffing Time)
Time frame: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
Puff Topography (Average Puff Duration)
Time frame: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
Puff Topography (Puff Number)
Time frame: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
Puff Topography (Inhaled Volume)
Time frame: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
Toxicants (Carcinogenic and Probably or Possibly Carcinogenic) Exposure
Time frame: During the 2 participant visits for both trials (partial and total). Toxicant exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
TPM (Total Particular Matter) Exposure
Time frame: During the 2 participant visits for both trials (partial and total). Total Particular Matter exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
Lung Function Tests (LFTs) Change
Time frame: During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
Lung Function Tests (LFTs) (% Predicted Change)
Time frame: During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
Minnesota Nicotine Withdrawal Scale (MNWS)
Time frame: 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 (QSU)
Time frame: 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
Duke Sensory Questionnaire (DSQ)
Time frame: 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
Modified Cigarette Evaluation Questionnaire (mCEQ)
Time frame: 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
Visual Analogue Scale (VAS)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42288659Roy S, Chowdhury S, Ferdous T, Shihadeh A, Salman R, El Hage R, Salam S, Bursac Z, Maziak W. Predicting nicotine emissions and plasma nicotine boost in E-cigarette users using machine learning. Sci Rep. 2026 Jun 13. doi: 10.1038/s41598-026-57341-4. Online ahead of print.
- Derived from this study: PubMed 39058490Ferdous 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.
- Individual participant dataSharing planned: No
Related trials for Electronic Cigarette Use
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
Electronic Cigarette Use, Endothelial Dysfunction
Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wasim Maziak, PhD, MD principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% nicotine (Partial Nicotine Reduction), 3% or 2.4% nicotine (Partial Nicotine Reduction) and 5% nicotine (Total Nicotine Reduction) in people with Electronic Cigarette Use, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Nicotine Boost (time frame: During the 2 participant visits, blood was taken 2 times in each session: before and after approximately 60 minutes ad lib use.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05205382, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.