SmokingNCT05239884

CSD201202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System P12

A study testing ENDS Product A with 1.5% nicotine, ENDS Product B with 1.5% nicotine and ENDS Product C with 1.5% nicotine in people with Smoking and Tobacco Use, run by RAI Services Company 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

This is an open-label, randomized, 8-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers and… Read more about this study

Who is it for?: Ages 21 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Smoking, Tobacco Use
What is being tested?: ENDS Product A with 1.5% nicotine, ENDS Product B with 1.5% nicotine and ENDS Product C with 1.5% nicotine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 14 Mar 2022to 15 Apr 2022
Phase: Interventional
Are there results?: None posted in the registry

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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.
Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
Positive urine cotinine test at Screening.
Smokes only combustible filtered, menthol or non-menthol combustible cigarettes (CC), 83 mm to 100 mm in length.
Agrees to smoke same usual brand (UB) cigarette throughout the study period. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the subject.

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Subjects must meet one (a or b) of the following tobacco use conditions:
Smokes at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the Principal Investigator (PI).
Dual user of CC and electronic cigarettes (ECs) who self-reports:
Smoking at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to screening due to illness, quit attempt or clinical study participation will be allowed at the discretion of the Investigator and ii. Using a nicotine-containing electronic nicotine delivery system (ENDS) (cartridge or a tank system).
Willing to use only UB cigarette and ENDS during the study period.
Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each Test Session.
Females must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until End-of-Study.
Agrees to in-clinic confinement of 10 days and 9 nights.

Who cannot join

Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
History, presence of, or clinical laboratory test results indicating diabetes.
Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95mmHg, measured after being seated for five minutes at Screening and at check-in Day 1.
Weight of ≤ 110 pounds.
Hemoglobin level is < 12.5 for females or <13.0 for males g/dL at Screening.
Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion pending approval from the Medical Monitor.

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Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
Must not be a current regular user (i.e., > 5 times per month) of any tobacco products other than CCs or ENDS within the last 6 months prior to screening.
Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to the signing of informed consent.
History or presence of bleeding or clotting disorders.
Any use of anticoagulants or daily use of aspirin (≥ 325 mg).
Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and check-in Day 1.
Plasma donation within (≤) 7 days prior to the signing of informed consent and between Screening and check-in Day 1.
Participation in another clinical trial within (≤) 30 days prior to the signing of informed consent. The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study.
Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or Day 1.
Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous quit attempt within (≤) 30 days prior to the signing of the ICF.
Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol result at Screening or Day 1.
Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
Determined by the PI to be inappropriate for this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

High Point Clinical Trials Center
High Point, North Carolina, 27265

Other trials in United States

About this study

Official title: CSD201202: A Randomized, Crossover, Confinement Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System P12

Read the detailed description

This study is designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.

Potential subjects will complete a pre-screening interview and a Screening Visit to assess eligibility within 45 days prior to enrollment, randomization and confinement.

Following the Screening Visit, eligible subjects will be scheduled for a check-in and randomization visit. At the check-in and randomization visit, subjects' continued eligibility will be confirmed prior to being randomized to a product use sequence and beginning 9 nights and 10 days of confinement.

Starting on study Day 1, subjects will start a Pre-study ENDS IP Acclimation Period. During Pre-Study Product Acclimation Period, subjects will be required to acclimate to each of the ENDS IP at least once, while having access to their usual brand (UB) cigarettes for ad libitum use. Starting on Day 3, subjects will participate in eight separate Test Sessions for nicotine PK assessment, one for each ENDS IP. For approximately a half day prior to each respective Test Session (starting on Day 2), subjects will use the assigned ENDS IP for the following day's Test Session at least four times.

Starting on Day 3 and continuing through Day 10, subjects will participate in eight separate Test Sessions, one for each IP that will last for approximately 4 hours following the start of 5 minutes of ad libitum IP use. During each Test Session, subjects will use one of the eight IPs. The ENDS IP for each Test Session will be determined based on a randomly assigned ENDS IP presentation schedule, where an 8-sequence ENDS IP use schedule will be generated using a Williams Design. Each Test Session will be preceded by a 12-hour tobacco/nicotine product abstention the night before.

Conditions: Smoking, Tobacco Use
Being tested: ENDS Product A with 1.5% nicotine, ENDS Product B with 1.5% nicotine, ENDS Product C with 1.5% nicotine, ENDS Product D with 1.5% nicotine, ENDS Product E with 1.5% nicotine
Medical subject headings: Smoking, Tobacco Use

What participants receive

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

ENDS Product A with 1.5% nicotineOther
P1211216, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
ENDS Product B with 1.5% nicotineOther
P1213516, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
ENDS Product C with 1.5% nicotineOther
P1213416, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
ENDS Product D with 1.5% nicotineOther
P1212716, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
ENDS Product E with 1.5% nicotineOther
P1213716, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
ENDS Product F with 1.5% nicotineOther
P1213816, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
ENDS Product G with 1.5% nicotineOther
P1211916, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
ENDS Product H with 1.5% nicotineOther
P1210016, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine

Study groups in NCT05239884
Study group	Role	What they receive
Product usage order EFDGCHBA	Experimental	Subjects will use each of the 8 products (EFDGCHBA) during an evaluation period, followed by a 4 hour Test Session Receives: Other: ENDS Product A with 1.5% nicotine; Other: ENDS Product B with 1.5% nicotine; Other: ENDS Product C with 1.5% nicotine; Other: ENDS Product D with 1.5% nicotine; Other: ENDS Product E with 1.5% nicotine; Other: ENDS Product F with 1.5% nicotine; Other: ENDS Product G with 1.5% nicotine; Other: ENDS Product H with 1.5% nicotine
Product usage order HAGBFCED	Experimental	Subjects will use each of the 8 products (HAGBFCED) during an evaluation period, followed by a 4 hour Test Session Receives: Other: ENDS Product A with 1.5% nicotine; Other: ENDS Product B with 1.5% nicotine; Other: ENDS Product C with 1.5% nicotine; Other: ENDS Product D with 1.5% nicotine; Other: ENDS Product E with 1.5% nicotine; Other: ENDS Product F with 1.5% nicotine; Other: ENDS Product G with 1.5% nicotine; Other: ENDS Product H with 1.5% nicotine
Product usage order CDBEAFHG	Experimental	Subjects will use each of the 8 products (CDBEAFHG) during an evaluation period, followed by a 4 hour Test Session Receives: Other: ENDS Product A with 1.5% nicotine; Other: ENDS Product B with 1.5% nicotine; Other: ENDS Product C with 1.5% nicotine; Other: ENDS Product D with 1.5% nicotine; Other: ENDS Product E with 1.5% nicotine; Other: ENDS Product F with 1.5% nicotine; Other: ENDS Product G with 1.5% nicotine; Other: ENDS Product H with 1.5% nicotine
Product usage order DECFBGAH	Experimental	Subjects will use each of the 8 products (DECFBGAH) during an evaluation period, followed by a 4 hour Test Session Receives: Other: ENDS Product A with 1.5% nicotine; Other: ENDS Product B with 1.5% nicotine; Other: ENDS Product C with 1.5% nicotine; Other: ENDS Product D with 1.5% nicotine; Other: ENDS Product E with 1.5% nicotine; Other: ENDS Product F with 1.5% nicotine; Other: ENDS Product G with 1.5% nicotine; Other: ENDS Product H with 1.5% nicotine
Product usage order FGEHDACB	Experimental	Subjects will use each of the 8 products (FGEHDACB) during an evaluation period, followed by a 4 hour Test Session Receives: Other: ENDS Product A with 1.5% nicotine; Other: ENDS Product B with 1.5% nicotine; Other: ENDS Product C with 1.5% nicotine; Other: ENDS Product D with 1.5% nicotine; Other: ENDS Product E with 1.5% nicotine; Other: ENDS Product F with 1.5% nicotine; Other: ENDS Product G with 1.5% nicotine; Other: ENDS Product H with 1.5% nicotine
Product usage order BCADHEGF	Experimental	Subjects will use each of the 8 products (BCADHEGF) during an evaluation period, followed by a 4 hour Test Session Receives: Other: ENDS Product A with 1.5% nicotine; Other: ENDS Product B with 1.5% nicotine; Other: ENDS Product C with 1.5% nicotine; Other: ENDS Product D with 1.5% nicotine; Other: ENDS Product E with 1.5% nicotine; Other: ENDS Product F with 1.5% nicotine; Other: ENDS Product G with 1.5% nicotine; Other: ENDS Product H with 1.5% nicotine
Product usage order ABHCGDFE	Experimental	Subjects will use each of the 8 products (ABHCGDFE) during an evaluation period, followed by a 4 hour Test Session Receives: Other: ENDS Product A with 1.5% nicotine; Other: ENDS Product B with 1.5% nicotine; Other: ENDS Product C with 1.5% nicotine; Other: ENDS Product D with 1.5% nicotine; Other: ENDS Product E with 1.5% nicotine; Other: ENDS Product F with 1.5% nicotine; Other: ENDS Product G with 1.5% nicotine; Other: ENDS Product H with 1.5% nicotine
Product usage order GHFAEBDC	Experimental	Subjects will use each of the 8 products (GHFAEBDC) during an evaluation period, followed by a 4 hour Test Session Receives: Other: ENDS Product A with 1.5% nicotine; Other: ENDS Product B with 1.5% nicotine; Other: ENDS Product C with 1.5% nicotine; Other: ENDS Product D with 1.5% nicotine; Other: ENDS Product E with 1.5% nicotine; Other: ENDS Product F with 1.5% nicotine; Other: ENDS Product G with 1.5% nicotine; Other: ENDS Product H with 1.5% nicotine

What is being measured

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

AUC nic 0-240
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use. A relative estimate of nicotine absorption that results from a single use of each of the ENDS IP.
Measured: 0 to 240 minutes
Cmax
The maximum plasma concentration of nicotine attained over 240 minutes after the start of ENDS IP use.
Measured: 240 minutes

Timeline

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

14 Mar 202215 Apr 2022

First posted15 Feb 2022
Study start14 Mar 2022
Primary completion15 Apr 2022
Study completion15 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokingStudies of the same condition, open and under way.
More trials run by RAI Services CompanyThe 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05239884
Sponsor's protocol ID: CSD201202
Status last verified: Jun 2022
First submitted: 4 Feb 2022
Last updated: 24 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kanobe MN, Baxter SA, Prevette K, Jin T, Tapia MA, Ayoku S, Dull GM, Makena P, Mohrmann J, Keyser BM, Gale N, Jordan KG. Assessment of nicotine pharmacokinetics and abuse liability in randomized, crossover studies of Vuse Alto electronic nicotine delivery systems. Front Pharmacol. 2026 Jul 14;17:1796858. doi: 10.3389/fphar.2026.1796858. eCollection 2026.
PubMed 42523979

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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Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CSD201202: A Randomized, Crossover, Confinement Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System P12
ClinicalTrials.gov ID: NCT05239884
Acronym / sponsor ID: CSD201202
Conditions: Smoking, Tobacco Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: RAI Services CompanyIndustry (pharma, biotech, devices)
Study start: 14 Mar 2022 (actual)
Primary completion: 15 Apr 2022 (actual)
Study completion: 15 Apr 2022 (actual)
First posted: 15 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Potential subjects will complete a pre-screening interview and a Screening Visit to assess eligibility within 45 days prior to enrollment, randomization and confinement.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Product usage order EFDGCHBA	Experimental	Other: ENDS Product A with 1.5% nicotine, Other: ENDS Product B with 1.5% nicotine, Other: ENDS Product C with 1.5% nicotine, Other: ENDS Product D with 1.5% nicotine, Other: ENDS Product E with 1.5% nicotine, Other: ENDS Product F with 1.5% nicotine, Other: ENDS Product G with 1.5% nicotine, Other: ENDS Product H with 1.5% nicotineSubjects will use each of the 8 products (EFDGCHBA) during an evaluation period, followed by a 4 hour Test Session
Product usage order HAGBFCED	Experimental	Other: ENDS Product A with 1.5% nicotine, Other: ENDS Product B with 1.5% nicotine, Other: ENDS Product C with 1.5% nicotine, Other: ENDS Product D with 1.5% nicotine, Other: ENDS Product E with 1.5% nicotine, Other: ENDS Product F with 1.5% nicotine, Other: ENDS Product G with 1.5% nicotine, Other: ENDS Product H with 1.5% nicotineSubjects will use each of the 8 products (HAGBFCED) during an evaluation period, followed by a 4 hour Test Session
Product usage order CDBEAFHG	Experimental	Other: ENDS Product A with 1.5% nicotine, Other: ENDS Product B with 1.5% nicotine, Other: ENDS Product C with 1.5% nicotine, Other: ENDS Product D with 1.5% nicotine, Other: ENDS Product E with 1.5% nicotine, Other: ENDS Product F with 1.5% nicotine, Other: ENDS Product G with 1.5% nicotine, Other: ENDS Product H with 1.5% nicotineSubjects will use each of the 8 products (CDBEAFHG) during an evaluation period, followed by a 4 hour Test Session
Product usage order DECFBGAH	Experimental	Other: ENDS Product A with 1.5% nicotine, Other: ENDS Product B with 1.5% nicotine, Other: ENDS Product C with 1.5% nicotine, Other: ENDS Product D with 1.5% nicotine, Other: ENDS Product E with 1.5% nicotine, Other: ENDS Product F with 1.5% nicotine, Other: ENDS Product G with 1.5% nicotine, Other: ENDS Product H with 1.5% nicotineSubjects will use each of the 8 products (DECFBGAH) during an evaluation period, followed by a 4 hour Test Session
Product usage order FGEHDACB	Experimental	Other: ENDS Product A with 1.5% nicotine, Other: ENDS Product B with 1.5% nicotine, Other: ENDS Product C with 1.5% nicotine, Other: ENDS Product D with 1.5% nicotine, Other: ENDS Product E with 1.5% nicotine, Other: ENDS Product F with 1.5% nicotine, Other: ENDS Product G with 1.5% nicotine, Other: ENDS Product H with 1.5% nicotineSubjects will use each of the 8 products (FGEHDACB) during an evaluation period, followed by a 4 hour Test Session
Product usage order BCADHEGF	Experimental	Other: ENDS Product A with 1.5% nicotine, Other: ENDS Product B with 1.5% nicotine, Other: ENDS Product C with 1.5% nicotine, Other: ENDS Product D with 1.5% nicotine, Other: ENDS Product E with 1.5% nicotine, Other: ENDS Product F with 1.5% nicotine, Other: ENDS Product G with 1.5% nicotine, Other: ENDS Product H with 1.5% nicotineSubjects will use each of the 8 products (BCADHEGF) during an evaluation period, followed by a 4 hour Test Session
Product usage order ABHCGDFE	Experimental	Other: ENDS Product A with 1.5% nicotine, Other: ENDS Product B with 1.5% nicotine, Other: ENDS Product C with 1.5% nicotine, Other: ENDS Product D with 1.5% nicotine, Other: ENDS Product E with 1.5% nicotine, Other: ENDS Product F with 1.5% nicotine, Other: ENDS Product G with 1.5% nicotine, Other: ENDS Product H with 1.5% nicotineSubjects will use each of the 8 products (ABHCGDFE) during an evaluation period, followed by a 4 hour Test Session
Product usage order GHFAEBDC	Experimental	Other: ENDS Product A with 1.5% nicotine, Other: ENDS Product B with 1.5% nicotine, Other: ENDS Product C with 1.5% nicotine, Other: ENDS Product D with 1.5% nicotine, Other: ENDS Product E with 1.5% nicotine, Other: ENDS Product F with 1.5% nicotine, Other: ENDS Product G with 1.5% nicotine, Other: ENDS Product H with 1.5% nicotineSubjects will use each of the 8 products (GHFAEBDC) during an evaluation period, followed by a 4 hour Test Session

Who may qualify

Ages: 21 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.
Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
Positive urine cotinine test at Screening.
Smokes only combustible filtered, menthol or non-menthol combustible cigarettes (CC), 83 mm to 100 mm in length.

Key exclusion criteria (22 listed)

Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
History, presence of, or clinical laboratory test results indicating diabetes.
Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95mmHg, measured after being seated for five minutes at Screening and at check-in Day 1.
Weight of ≤ 110 pounds.
Hemoglobin level is < 12.5 for females or <13.0 for males g/dL at Screening.

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
ENDS Product A with 1.5% nicotineP1211216, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine	Other	Product usage order ABHCGDFE, Product usage order BCADHEGF, Product usage order CDBEAFHG, Product usage order DECFBGAH, Product usage order EFDGCHBA, Product usage order FGEHDACB, Product usage order GHFAEBDC, Product usage order HAGBFCED
ENDS Product B with 1.5% nicotineP1213516, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine	Other	Product usage order ABHCGDFE, Product usage order BCADHEGF, Product usage order CDBEAFHG, Product usage order DECFBGAH, Product usage order EFDGCHBA, Product usage order FGEHDACB, Product usage order GHFAEBDC, Product usage order HAGBFCED
ENDS Product C with 1.5% nicotineP1213416, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine	Other	Product usage order ABHCGDFE, Product usage order BCADHEGF, Product usage order CDBEAFHG, Product usage order DECFBGAH, Product usage order EFDGCHBA, Product usage order FGEHDACB, Product usage order GHFAEBDC, Product usage order HAGBFCED
ENDS Product D with 1.5% nicotineP1212716, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine	Other	Product usage order ABHCGDFE, Product usage order BCADHEGF, Product usage order CDBEAFHG, Product usage order DECFBGAH, Product usage order EFDGCHBA, Product usage order FGEHDACB, Product usage order GHFAEBDC, Product usage order HAGBFCED
ENDS Product E with 1.5% nicotineP1213716, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine	Other	Product usage order ABHCGDFE, Product usage order BCADHEGF, Product usage order CDBEAFHG, Product usage order DECFBGAH, Product usage order EFDGCHBA, Product usage order FGEHDACB, Product usage order GHFAEBDC, Product usage order HAGBFCED
ENDS Product F with 1.5% nicotineP1213816, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine	Other	Product usage order ABHCGDFE, Product usage order BCADHEGF, Product usage order CDBEAFHG, Product usage order DECFBGAH, Product usage order EFDGCHBA, Product usage order FGEHDACB, Product usage order GHFAEBDC, Product usage order HAGBFCED
ENDS Product G with 1.5% nicotineP1211916, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine	Other	Product usage order ABHCGDFE, Product usage order BCADHEGF, Product usage order CDBEAFHG, Product usage order DECFBGAH, Product usage order EFDGCHBA, Product usage order FGEHDACB, Product usage order GHFAEBDC, Product usage order HAGBFCED
ENDS Product H with 1.5% nicotineP1210016, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine	Other	Product usage order ABHCGDFE, Product usage order BCADHEGF, Product usage order CDBEAFHG, Product usage order DECFBGAH, Product usage order EFDGCHBA, Product usage order FGEHDACB, Product usage order GHFAEBDC, Product usage order HAGBFCED

Primary outcome

AUC nic 0-240
Time frame: 0 to 240 minutes
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use. A relative estimate of nicotine absorption that results from a single use of each of the ENDS IP.
Cmax
Time frame: 240 minutes
The maximum plasma concentration of nicotine attained over 240 minutes after the start of ENDS IP use.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
Derived from this study: PubMed 42523979Kanobe MN, Baxter SA, Prevette K, Jin T, Tapia MA, Ayoku S, Dull GM, Makena P, Mohrmann J, Keyser BM, Gale N, Jordan KG. Assessment of nicotine pharmacokinetics and abuse liability in randomized, crossover studies of Vuse Alto electronic nicotine delivery systems. Front Pharmacol. 2026 Jul 14;17:1796858. doi: 10.3389/fphar.2026.1796858. eCollection 2026.
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.

Jason Hong, MD study director

RAIS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 22 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 24 Jun 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

AUC nic 0-240 (time frame: 0 to 240 minutes). The study lists 2 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 NCT05239884, 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 24 Jun 2022.