E-cigarette UseNCT05458895

Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth

A study testing ECIG lab session 1, ECIG lab session 2 and ECIG lab session 3 in people with E-cigarette Use, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 25 years
Conditions the study is for: E-cigarette Use
What is being tested?: ECIG lab session 1, ECIG lab session 2 and ECIG lab session 3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteUnited States
Study dates: 2 Dec 2021to 7 Aug 2023
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 25 years
All sexes
No healthy volunteers
Adult

Who may be able to join

A current exclusive e-cigarette user (>= 1 vaping bout per day) for at least the past 3 months (confirmed in lab by salivary cotinine)
21-25 years old
Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
Willing to complete five, 6 hour lab visits
Able to read and speak English
Willing to provide informed consent

Who cannot join

Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
History of cardiac event or distress within the past 3 months
Currently pregnant (determined using urine pregnancy test), planning to become pregnant, or breastfeeding
Use of other tobacco products > 5 days in the past month
Current marijuana use > 5 times per month
Currently engaging in a vaping cessation attempt
Ohio State University (OSU) verifies study project 2 current membership/past participation

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210

Other trials in United States

About this study

This clinical trial examines the influence of nicotine form, concentration, and e-liquid flavor on youth vaping behavior, as well as the heart and lung effects associated with this behavior. Electronic cigarette (e-cig) "vaping", while being promoted as a safer alternative to conventional cigarettes, has disproportionately attracted adolescents and young adults ("youth"). This trial may help researchers understand how nicotine form, concentration, and flavor affects people's vaping behaviors and health.

Read the detailed description

We will examine the influence of nicotine form and concentration, and e-liquid flavor on youth vaping behavior, nicotine uptake, abuse liability, toxicant exposure, and acute cardiovascular and pulmonary effects. Participants will complete 9 vaping sessions. Each vaping session will include a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. During the first session, participants will use their own e-cig and e-liquid; for the following 8 sessions, participants will vape a study-provided e-cig and e-liquid.

Conditions: E-cigarette Use
Being tested: ECIG lab session 1, ECIG lab session 2, ECIG lab session 3, ECIG lab session 4, ECIG lab session 5
Medical subject headings: Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ECIG lab session 1Other
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
ECIG lab session 2Other
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
ECIG lab session 3Other
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
ECIG lab session 4Other
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
ECIG lab session 5Other
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
ECIG lab session 6Other
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
ECIG lab session 7Other
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
ECIG lab session 8Other
vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Study groups in NCT05458895
Study group	Role	What they receive
High concentration free-base nicotine (5%), Tobacco flavor	Experimental	Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. Receives: Other: ECIG lab session 1
High concentration nicotine salt (5%), Tobacco flavor	Experimental	Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. Receives: Other: ECIG lab session 2
High concentration free-base nicotine (5%), Menthol flavor	Experimental	Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. Receives: Other: ECIG lab session 3
High concentration nicotine salt (5%), Menthol flavor	Experimental	Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. Receives: Other: ECIG lab session 4
Low concentration free-base nicotine (1%), Tobacco flavor	Experimental	Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. Receives: Other: ECIG lab session 5
Low concentration nicotine salt (1%), Tobacco flavor	Experimental	Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. Receives: Other: ECIG lab session 6
Low concentration free-base nicotine (1%), Menthol flavor	Experimental	Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. Receives: Other: ECIG lab session 7
Low concentration nicotine salt (1%), Menthol flavor	Experimental	Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. Receives: Other: ECIG lab session 8

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Nicotine Concentration
Plasma nicotine concentration from blood drawn (3mL) 4 times in each session at baseline (0 min), 5 min., 10 min., 35 min.
Measured: 0, 5, 10, 35 min.
Puff Count
E-cig puff topography data collection for abuse liability. Number of puffs taken during the 30 minutes of ad libitum (as desired) vaping session.
Measured: 30 minutes
Average Puff Duration
E-cig puff topography data collection for abuse liability. Average puff duration during the 30 minutes of ad libitum (as desired) vaping session, in seconds.
Measured: 30 minutes
Average Puff Volume
E-cig puff topography data collection for abuse liability. The total volume of all puffs taken for each participant during the 30 minutes of ad libitum (as desired) vaping session, in ml.
Measured: 30 minutes
Lung Function Assessment
Lung function data will be collect using a handheld spirometry device. Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Measures amount inhaled and how quickly exhaled.
Change from baseline in forced expiratory volume (FEV) Change from baseline in forced vital capacity (FVC)
Measured: Baseline and 35 minutes
Airway Inflammation (NIOX VERO)
Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Airway inflammation will be assessed using exhaled nitric oxide via the NIOX VERO.
Measured: 35 minutes

Secondary outcomes (7)

Sensory E-Cigarette Expectancies Scale (SEES)
Background measures. Comprised of 9 items each of which range 0-4 from "never" to "almost always".
The 3 subscales (enjoyment of taste and smell, pleasurable physical sensations, enjoyment of vapor cloud production) are the average of 3 items each; scores range from 0 to 4 with higher scores indicating greater enjoyment.
Measured: Baseline
Modified Cigarette Dependence Scale
Assess e-cigarette dependence.
Scores range from 5 to 25 with higher scores indicating a greater level of dependence.
Measured: Baseline
Drug Effects/Liking Questionnaire
An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of UBMC and all three study products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness. Five visual analog scale items ranging from 0 ('not at all') to 100 ('extremely') assessed wanting to smoke the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying.
Measured: 35 minutes
Modified Cigarette Evaluation Questionnaire (mCEQ)
The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses to e-cigarettes (e.g., reward, satisfaction). The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, an craving reduction.
Measured: 35 minutes
E-cigarette Purchase Task - Breakpoint
Behavioral economic demand Asks participants how much they would be willing to pay (ranging from 0¢ to $1,120) for a puff of their study product. Specifically they will be asked, "Thinking about the study product, how many puffs of e-cigarette would you smoke if they were each at the following prices?". Breakpoint is the first price of zero consumption.
Measured: 35 minutes
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form
E-cig craving/suppression of craving and withdraw will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges (QSU): Brief Form with a modified version (replacing the word "cigarette" with "e-cigarette"). This is a 10-item measure where participants rate smoking/vaping-related items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke/vape; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving to smoke/vape.
Measured: 0, 5, 10, 35 min.
Vascular Reactivity
Endothelial function will be collected through EndoPAT device. Specifically, the natural log of RHI, the reactive hyperemia index, will be recorded.
The RHI (Reactive Hyperemia Index) or LnRHI (natural log of RHI) is the post-to-pre occlusion PAT™ signal ratio in the occluded arm, relative to the same ratio in the control arm, corrected for baseline vascular tone. Values less than 1.67 or higher than 0.51 are considered to be abnormal.
Measured: Pre-Vaping Session at Visit 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 20217 Aug 2023

First posted14 Jul 2022
Study start2 Dec 2021
Primary completion7 Aug 2023
Study completion7 Aug 2023

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 (1)Papers the sponsor has linked to this study.
Other trials for E-cigarette UseStudies of the same condition, open and under way.
More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
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: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05458895
Sponsor's protocol ID: OSU-20313
Other IDs: NCI-2021-06437
Status last verified: Sep 2024
First submitted: 20 Sep 2021
Last updated: 22 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cho YJ, Mehta T, Hinton A, Sloan R, Nshimiyimana J, Tackett AP, Roberts ME, Brinkman MC, Wagener TL. E-Cigarette Nicotine Delivery Among Young Adults by Nicotine Form, Concentration, and Flavor: A Crossover Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2426702. doi: 10.1001/jamanetworkopen.2024.26702.
PubMed 39120901

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
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Active, not recruiting
Mindful Breaths: Mindfulness for Young Adult Vaping
Vaping Cessation

All E-cigarette Use trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth
ClinicalTrials.gov ID: NCT05458895
Acronym / sponsor ID: OSU-20313
Conditions: E-cigarette Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
Study start: 2 Dec 2021 (actual)
Primary completion: 7 Aug 2023 (actual)
Study completion: 7 Aug 2023 (actual)
First posted: 14 Jul 2022 (actual)
Results: Posted 22 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
High concentration free-base nicotine (5%), Tobacco flavor	Experimental	Other: ECIG lab session 1Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
High concentration nicotine salt (5%), Tobacco flavor	Experimental	Other: ECIG lab session 2Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
High concentration free-base nicotine (5%), Menthol flavor	Experimental	Other: ECIG lab session 3Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
High concentration nicotine salt (5%), Menthol flavor	Experimental	Other: ECIG lab session 4Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Low concentration free-base nicotine (1%), Tobacco flavor	Experimental	Other: ECIG lab session 5Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Low concentration nicotine salt (1%), Tobacco flavor	Experimental	Other: ECIG lab session 6Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Low concentration free-base nicotine (1%), Menthol flavor	Experimental	Other: ECIG lab session 7Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Low concentration nicotine salt (1%), Menthol flavor	Experimental	Other: ECIG lab session 8Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Who may qualify

Ages: 21 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

A current exclusive e-cigarette user (>= 1 vaping bout per day) for at least the past 3 months (confirmed in lab by salivary cotinine)
21-25 years old
Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
Willing to complete five, 6 hour lab visits
Able to read and speak English

Key exclusion criteria (8 listed)

Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
History of cardiac event or distress within the past 3 months
Currently pregnant (determined using urine pregnancy test), planning to become pregnant, or breastfeeding
Use of other tobacco products > 5 days in the past month

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
ECIG lab session 1vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Other	High concentration free-base nicotine (5%), Tobacco flavor
ECIG lab session 2vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Other	High concentration nicotine salt (5%), Tobacco flavor
ECIG lab session 3vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Other	High concentration free-base nicotine (5%), Menthol flavor
ECIG lab session 4vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Other	High concentration nicotine salt (5%), Menthol flavor
ECIG lab session 5vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Other	Low concentration free-base nicotine (1%), Tobacco flavor
ECIG lab session 6vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Other	Low concentration nicotine salt (1%), Tobacco flavor
ECIG lab session 7vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Other	Low concentration free-base nicotine (1%), Menthol flavor
ECIG lab session 8vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Other	Low concentration nicotine salt (1%), Menthol flavor

Primary outcome

Plasma Nicotine Concentration
Time frame: 0, 5, 10, 35 min.
Plasma nicotine concentration from blood drawn (3mL) 4 times in each session at baseline (0 min), 5 min., 10 min., 35 min.
Puff Count
Time frame: 30 minutes
E-cig puff topography data collection for abuse liability. Number of puffs taken during the 30 minutes of ad libitum (as desired) vaping session.
Average Puff Duration
Time frame: 30 minutes
E-cig puff topography data collection for abuse liability. Average puff duration during the 30 minutes of ad libitum (as desired) vaping session, in seconds.
Average Puff Volume
Time frame: 30 minutes
E-cig puff topography data collection for abuse liability. The total volume of all puffs taken for each participant during the 30 minutes of ad libitum (as desired) vaping session, in ml.
Lung Function Assessment
Time frame: Baseline and 35 minutes
Lung function data will be collect using a handheld spirometry device. Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Measures amount inhaled and how quickly exhaled. Change from baseline in forced expiratory volume (FEV) Change from baseline in forced vital capacity (FVC)
Airway Inflammation (NIOX VERO)
Time frame: 35 minutes
Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Airway inflammation will be assessed using exhaled nitric oxide via the NIOX VERO.

7 secondary outcomes

Sensory E-Cigarette Expectancies Scale (SEES)
Time frame: Baseline
Modified Cigarette Dependence Scale
Time frame: Baseline
Drug Effects/Liking Questionnaire
Time frame: 35 minutes
Modified Cigarette Evaluation Questionnaire (mCEQ)
Time frame: 35 minutes
E-cigarette Purchase Task - Breakpoint
Time frame: 35 minutes
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form
Time frame: 0, 5, 10, 35 min.
Vascular Reactivity
Time frame: Pre-Vaping Session at Visit 1

Results and safety

Results posted to the registry on 22 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Population	88	60

Primary outcome: Plasma Nicotine Concentration

Time frame: 0, 5, 10, 35 min.. Median (Inter-Quartile Range). Unit: ng/ml

Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n = 63	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n = 60	Low Concentration Nicotine Salt (1%), Menthol Flavor n = 60	Low Concentration Nicotine Salt (1%), Tobacco Flavor n = 63	High Concentration Free-base Nicotine (5%), Menthol Flavor n = 62	High Concentration Free-base Nicotine (5%), Tobacco Flavor n = 62	High Concentration Nicotine Salt (5%), Menthol Flavor n = 59	High Concentration Nicotine Salt (5%), Tobacco Flavor n = 62	Usual Brand n = 83
Baseline	0.78 (0.32 to 1.65)	1.08 (0.45 to 2.34)	0.89 (0.35 to 1.89)	1.16 (0.49 to 2.62)	0.80 (0.30 to 1.92)	0.88 (0.38 to 2.10)	1.03 (0.48 to 2.36)	1.01 (0.51 to 2.21)	0.43 (0.19 to 0.83)
5 Minutes	3.04 (1.59 to 5.16)	2.63 (1.32 to 4.73)	4.47 (2.30 to 7.61)	4.66 (2.61 to 8.10)	3.63 (1.72 to 6.15)	3.29 (1.68 to 5.80)	7.83 (4.33 to 16.90)	8.76 (4.13 to 14.90)	12.50 (7.49 to 19.30)
10 Minutes	3.12 (2.02 to 5.76)	3.18 (1.75 to 5.17)	4.92 (2.35 to 7.07)	4.66 (2.67 to 7.27)	4.45 (2.46 to 7.90)	4.14 (1.81 to 7.18)	8.10 (4.97 to 19.10)	7.02 (4.29 to 16.60)	14.10 (8.11 to 21.00)
35 Minutes	4.46 (2.45 to 8.35)	3.51 (2.07 to 7.44)	5.97 (2.91 to 10.70)	5.28 (2.98 to 11.45)	6.39 (3.59 to 13.95)	4.23 (2.19 to 10.70)	12.90 (6.00 to 27.30)	10.60 (4.47 to 21.60)	20.40 (10.25 to 31.60)

Population analysed: Number analyzed is slightly different at each of the time points due to missing blood draws

Primary outcome: Puff Count

Time frame: 30 minutes. Mean (Standard Deviation). Unit: Number of Puffs

Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n = 65	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n = 64	Low Concentration Nicotine Salt (1%), Menthol Flavor n = 61	Low Concentration Nicotine Salt (1%), Tobacco Flavor n = 64	High Concentration Free-base Nicotine (5%), Menthol Flavor n = 64	High Concentration Free-base Nicotine (5%), Tobacco Flavor n = 63	High Concentration Nicotine Salt (5%), Menthol Flavor n = 60	High Concentration Nicotine Salt (5%), Tobacco Flavor n = 65	Usual Brand n = 87
Value	16.17 (12.04)	16.67 (13.84)	17.67 (13.54)	17.88 (13.90)	12.52 (12.13)	11.29 (12.64)	14.50 (11.80)	13.97 (12.07)	12.40 (10.69)

Primary outcome: Average Puff Duration

Time frame: 30 minutes. Mean (Standard Deviation). Unit: seconds

Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n = 56	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n = 55	Low Concentration Nicotine Salt (1%), Menthol Flavor n = 57	Low Concentration Nicotine Salt (1%), Tobacco Flavor n = 58	High Concentration Free-base Nicotine (5%), Menthol Flavor n = 46	High Concentration Free-base Nicotine (5%), Tobacco Flavor n = 41	High Concentration Nicotine Salt (5%), Menthol Flavor n = 55	High Concentration Nicotine Salt (5%), Tobacco Flavor n = 54	Usual Brand n = 77
Value	3.20 (1.04)	3.04 (1.08)	3.16 (1.07)	3.15 (1.10)	2.65 (0.92)	2.57 (0.97)	2.77 (1.03)	2.75 (1.08)	2.70 (1.15)

Population analysed: Participants who attended the study visit and whose puff duration was able to be recorded.

Primary outcome: Average Puff Volume

Time frame: 30 minutes. Mean (Standard Deviation). Unit: ml

Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n = 64	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n = 62	Low Concentration Nicotine Salt (1%), Menthol Flavor n = 59	Low Concentration Nicotine Salt (1%), Tobacco Flavor n = 61	High Concentration Free-base Nicotine (5%), Menthol Flavor n = 53	High Concentration Free-base Nicotine (5%), Tobacco Flavor n = 54	High Concentration Nicotine Salt (5%), Menthol Flavor n = 57	High Concentration Nicotine Salt (5%), Tobacco Flavor n = 58	Usual Brand n = 82
Value	48.68 (17.28)	46.31 (18.44)	50.64 (22.05)	51.92 (30.01)	36.82 (12.13)	35.12 (13.16)	41.76 (15.35)	40.86 (17.26)	69.29 (40.42)

Population analysed: Participants who attended the study visit and whose puff volume was able to be recorded.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Concentration Free-base Nicotine (1%), Menthol Flavor	0 of 65 (0%)	0 of 65 (0%)	0 of 65
Low Concentration Free-base Nicotine (1%), Tobacco Flavor	0 of 64 (0%)	0 of 64 (0%)	0 of 64
Low Concentration Nicotine Salt (1%), Menthol Flavor	0 of 61 (0%)	0 of 61 (0%)	0 of 61
Low Concentration Nicotine Salt (1%), Tobacco Flavor	0 of 64 (0%)	0 of 64 (0%)	0 of 64
High Concentration Free-base Nicotine (5%), Menthol Flavor	0 of 64 (0%)	0 of 64 (0%)	0 of 64
High Concentration Free-base Nicotine (5%), Tobacco Flavor	0 of 63 (0%)	0 of 63 (0%)	0 of 63
High Concentration Nicotine Salt (5%), Menthol Flavor	0 of 60 (0%)	0 of 60 (0%)	0 of 60
High Concentration Nicotine Salt (5%), Tobacco Flavor	0 of 65 (0%)	0 of 65 (0%)	0 of 65
Usual Brand	0 of 87 (0%)	0 of 87 (0%)	0 of 87

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39120901Cho YJ, Mehta T, Hinton A, Sloan R, Nshimiyimana J, Tackett AP, Roberts ME, Brinkman MC, Wagener TL. E-Cigarette Nicotine Delivery Among Young Adults by Nicotine Form, Concentration, and Flavor: A Crossover Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2426702. doi: 10.1001/jamanetworkopen.2024.26702.
The JameslineLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Theodore L Wagener, PhD principal investigator

Ohio State University Comprehensive Cancer Center

Marielle Brinkman, BS principal investigator

Ohio State 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 ECIG lab session 1, ECIG lab session 2 and ECIG lab session 3 in people with E-cigarette Use, run by Ohio State University Comprehensive Cancer Center 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 8 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 22 Nov 2024. 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 22 Nov 2024). 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 Concentration (time frame: 0, 5, 10, 35 min.). The study lists 6 primary outcomes in all. 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 NCT05458895, which also lists 1 linked publication.

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 22 Nov 2024.