Healthy VolunteersNCT05457634
Nicotine Uptake and Abuse Liability Assessments of Blu Disposable Electronic Cigarettes
A study testing Combustible Cigarette, blu Disposable A and blu Disposable B in people with Healthy Volunteers, run by Fontem US LLC at 1 site in United States.
Trial summary
This study assesses the nicotine uptake, abuse liability and puffing topography of blu disposable e-cigarettes in adult combustible cigarette smokers. Nicotine uptake, subjective effects, and puff topography are evaluated and compared with subjects' usual brand combustible cigarette. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Combustible Cigarette, blu Disposable A and blu Disposable B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2021to 31 Aug 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be current smokers (≥10 per day) of combustible cigarettes for at least 6 continuous months before Visit 1 and may be occasional users of e-cigarettes
- Subjects have urine cotinine >200 ng/mL and exhaled carbon monoxide > 10 ppm at Screening
- Subject has a seated systolic blood pressure ≤160 mmHg, diastolic blood pressure
- ≤95 mmHg, and heart rate ≤100 bpm
- Females of childbearing potential who are practicing a reliable method of contraception
Who cannot join
- Subjects who have used any nicotine or tobacco product other than e-cigarettes or combustible cigarettes in the 14 days prior to Visit 1
- Subjects who have an acute illness requiring treatment in the 4 weeks prior to Visit 1
- Subjects with clinically significant and relevant abnormalities of medical history.
- Subjects who have used any prescription or over-the-counter smoking cessation treatments within 30 days prior to Visit 1
- Pregnant or breastfeeding female subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette
This study assesses the nicotine uptake, abuse liability and puffing topography of blu disposable e-cigarettes in adult combustible cigarette smokers. Nicotine uptake, subjective effects, and puff topography are evaluated and compared with subjects' usual brand combustible cigarette.
- Conditions
- Healthy Volunteers
- Being tested
- Combustible Cigarette, blu Disposable A, blu Disposable B, blu Disposable C, blu Disposable D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combustible CigaretteOther
Subjects smoke their Usual Brand Combustible Cigarette, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use.
blu Disposable AOther
Subjects use the blu disposable e-cigarette with flavor A, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use.
blu Disposable BOther
Subjects use the blu disposable e-cigarette with flavor B, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use.
blu Disposable COther
Subjects use the blu disposable e-cigarette with flavor C, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use.
blu Disposable DOther
Subjects use the blu disposable e-cigarette with flavor D, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use.
blu Disposable EOther
Subjects use the blu disposable e-cigarette with flavor E, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use.
| Study group | Role | What they receive |
|---|---|---|
| blu Disposable Flavor A | Experimental | Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor A Receives: Other: blu Disposable A |
| blu Disposable Flavor B | Experimental | Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor B Receives: Other: blu Disposable B |
| blu Disposable Flavor C | Experimental | Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor C Receives: Other: blu Disposable C |
| blu Disposable Flavor D | Experimental | Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor D Receives: Other: blu Disposable D |
| blu Disposable Flavor E | Experimental | Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor E Receives: Other: blu Disposable E |
| Combustible cigarette | Active comparator | Subjects who use their own brand of combustible cigarette Receives: Other: Combustible Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine Cmax0-120
Maximum plasma nicotine concentration, during the defined use session, adjusted for baseline nicotine
Measured: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
Nicotine Cmax120-180
Maximum plasma nicotine concentration during the ad libitum use session, adjusted for baseline nicotine
Measured: at 15, 30, 45, and 60 minutes after the start of the ad libitum use session (ad libitum session starts at 120 min relative to first puff of controlled use session)
Nicotine AUC0-120
Area under the plasma nicotine concentration-time curve from time 0 to 120 minutes during the defined use session
Measured: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
Nicotine AUC120-180
Area under the plasma nicotine concentration-time curve from time 120 minutes to 180 minutes, i.e. during the ad libitum use session
Measured: at 15, 30, 45, and 60 minutes after the start of the ad libitum use session
Urge to Smoke - Defined use
Subjects answer "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale: from "No Urge" at the left to "Very Strong Urge" at the right.
Measured: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
Urge to Smoke - Ad libitum use
Subjects answer "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale: from "No Urge" at the left to "Very Strong Urge" at the right.
Measured: at 15, 30, 45, and 60 minutes after the start of the ad libitum use session
Secondary outcomes (1)
Puff topography: puff count
Measured during the ad libitum use session with a CReSS Pocket topography device
Measured: Throughout ad libitum use session (60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start13 Jul 2021
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fontem US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457634
- Sponsor's protocol ID
- Fontem-PK-01
- Status last verified
- Sep 2025
- First submitted
- 11 Jul 2022
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette
- ClinicalTrials.gov ID
- NCT05457634
- Acronym / sponsor ID
- Fontem-PK-01
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fontem US LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 14 Jul 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.
This study assesses the nicotine uptake, abuse liability and puffing topography of blu disposable e-cigarettes in adult combustible cigarette smokers. Nicotine uptake, subjective effects, and puff topography are evaluated and compared with subjects' usual brand combustible cigarette.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| blu Disposable Flavor A | Experimental | Other: blu Disposable ASubjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor A |
| blu Disposable Flavor B | Experimental | Other: blu Disposable BSubjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor B |
| blu Disposable Flavor C | Experimental | Other: blu Disposable CSubjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor C |
| blu Disposable Flavor D | Experimental | Other: blu Disposable DSubjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor D |
| blu Disposable Flavor E | Experimental | Other: blu Disposable ESubjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor E |
| Combustible cigarette | Active comparator | Other: Combustible CigaretteSubjects who use their own brand of combustible cigarette |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be current smokers (≥10 per day) of combustible cigarettes for at least 6 continuous months before Visit 1 and may be occasional users of e-cigarettes
- Subjects have urine cotinine >200 ng/mL and exhaled carbon monoxide > 10 ppm at Screening
- Subject has a seated systolic blood pressure ≤160 mmHg, diastolic blood pressure
- ≤95 mmHg, and heart rate ≤100 bpm
- Females of childbearing potential who are practicing a reliable method of contraception
Key exclusion criteria (5 listed)
- Subjects who have used any nicotine or tobacco product other than e-cigarettes or combustible cigarettes in the 14 days prior to Visit 1
- Subjects who have an acute illness requiring treatment in the 4 weeks prior to Visit 1
- Subjects with clinically significant and relevant abnormalities of medical history.
- Subjects who have used any prescription or over-the-counter smoking cessation treatments within 30 days prior to Visit 1
- Pregnant or breastfeeding female subjects
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 |
|---|---|---|
| Combustible CigaretteSubjects smoke their Usual Brand Combustible Cigarette, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use. | Other | Combustible cigarette |
| blu Disposable ASubjects use the blu disposable e-cigarette with flavor A, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use. | Other | blu Disposable Flavor A |
| blu Disposable BSubjects use the blu disposable e-cigarette with flavor B, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use. | Other | blu Disposable Flavor B |
| blu Disposable CSubjects use the blu disposable e-cigarette with flavor C, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use. | Other | blu Disposable Flavor C |
| blu Disposable DSubjects use the blu disposable e-cigarette with flavor D, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use. | Other | blu Disposable Flavor D |
| blu Disposable ESubjects use the blu disposable e-cigarette with flavor E, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use. | Other | blu Disposable Flavor E |
Primary outcome
Nicotine Cmax0-120
Time frame: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
Maximum plasma nicotine concentration, during the defined use session, adjusted for baseline nicotine
Nicotine Cmax120-180
Time frame: at 15, 30, 45, and 60 minutes after the start of the ad libitum use session (ad libitum session starts at 120 min relative to first puff of controlled use session)
Maximum plasma nicotine concentration during the ad libitum use session, adjusted for baseline nicotine
Nicotine AUC0-120
Time frame: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
Area under the plasma nicotine concentration-time curve from time 0 to 120 minutes during the defined use session
Nicotine AUC120-180
Time frame: at 15, 30, 45, and 60 minutes after the start of the ad libitum use session
Area under the plasma nicotine concentration-time curve from time 120 minutes to 180 minutes, i.e. during the ad libitum use session
Urge to Smoke - Defined use
Time frame: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
Subjects answer "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale: from "No Urge" at the left to "Very Strong Urge" at the right.
Urge to Smoke - Ad libitum use
Time frame: at 15, 30, 45, and 60 minutes after the start of the ad libitum use session
Subjects answer "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale: from "No Urge" at the left to "Very Strong Urge" at the right.
1 secondary outcome
Puff topography: puff count
Time frame: Throughout ad libitum use session (60 minutes)
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 17 Sep 2025.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combustible Cigarette, blu Disposable A and blu Disposable B in people with Healthy Volunteers, run by Fontem US LLC 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 5 inclusion and 5 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 17 Sep 2025. 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?
Nicotine Cmax0-120 (time frame: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff). 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?
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 17 Sep 2025.