SmokingNCT03105804
CSD170301: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Four Different Electronic Cigarettes
A study testing FT21039, FT21041 and FT21044 in people with Smoking, run by RAI Services Company at 2 sites in United States.
Trial summary
To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four different marketed electronic cigarettes. Furthermore, to measure overall product liking by subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in the future. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- FT21039, FT21041 and FT21044
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Mar 2017to 27 Oct 2017
- 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 males and females, 21 to 60 years of age, inclusive, at Screening Visit.
- Subjects must meet one (a or b) of the following tobacco use conditions:
- Exclusive cigarette smoker who self-reports smoking at least (≥) 10 cigarettes per day 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.
- Dual user of combustible cigarettes and ECs who self-reports: 1. Smoking at least (≥) 10 cigarettes per day 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 2. Using a nicotine-containing cig-a-like EC or a tank system EC either daily or at least weekly for at least 3 months prior to Screening Visit.
- Willing to be confined overnight and abstain from tobacco- and nicotine- containing product use for 12 hours prior to IP use through Study Discharge.
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- Willing to use assigned IP during the study according to protocol.
- Expired breath carbon monoxide (ECO) level is ≥10 parts per million (ppm) at the Screening Visit and Study Day 1.
- Positive urine cotinine test at the Screening Visit and Study Day 1.
- No intent to quit smoking or vaping from Screening to Study Day 2.
- Females of childbearing age must be willing to use a form of contraception acceptable to the Investigator from the time of signing informed consent until Study Discharge, or be surgically sterile for at least 90 days prior to the Screening Visit.
Who cannot join
- Presence of clinically significant or unstable/uncontrolled acute or chronic medical conditions at the Screening Visit, as determined by the Investigator, that would preclude a subject from participating safely in the study (e.g., uncontrolled hypertension, diabetes, asthma or other lung disease, cardiac disease, neurological disease or psychiatric disorders) based on safety assessments such as clinical laboratory tests, pregnancy tests, medical history, and physical/oral examinations.
- At risk for heart disease, as determined by the Investigator.
- Systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥ 95 mmHg, measured after being seated for 5 minutes.
- Weight of ≤ 110 pounds.
- Poor peripheral venous access.
- Use of medicine for treatment of depression or asthma (e.g., paroxetine [Paxil®], montelukast [Singulair®], albuterol [Proventil® HFA]), as deemed clinically significant by the Investigator.
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- 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 Screening Visit.
- History or presence of hemophilia or other bleeding disorders.
- History or presence of clotting disorders with concomitant use of anticoagulants (e.g., clopidogrel [Plavix®], warfarin [Coumadin®, Jantoven®] and aspirin [> 325 mg/day]).
- Participation in another clinical trial within (≤) 30 days prior to the time of 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 consent of the current study.
- Positive test for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus antibody (anti-HCV).
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- Females ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- A positive urine drug screen without disclosure of corresponding concomitant medication(s) at the Screening Visit or on Study Day 1.
- A positive alcohol breathalyzer result at Screening Visit or on Study 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 Investigator to be inappropriate for the study, including a subject who is unable to communicate or unwilling to cooperate with the clinical staff.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
High Point Clinical Trials Center
High Point, North Carolina, 27265
Inflamax Research, Inc.
Neptune City, New Jersey, 07753
About this study
Official title: CSD170301: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Electronic Cigarettes
To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four different marketed electronic cigarettes. Furthermore, to measure overall product liking by subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in the future.
Read the detailed description
This will be a single-center, randomized, open-label, parallel study during which up to 140 healthy adult subjects, consisting of 35 subjects per marketed EC product, will be enrolled. Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The study will involve the use of four (4) marketed EC products in tobacco consumers who are exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e., intermittent EC users).
- Conditions
- Smoking
- Being tested
- FT21039, FT21041, FT21044, FT21042
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT21039Other
An electronic cigarette
FT21041Other
An electronic cigarette
FT21044Other
An electronic cigarette
FT21042Other
An electronic cigarette
| Study group | Role | What they receive |
|---|---|---|
| FT21039 Group | Experimental | 7 day at-home use of electronic cigarette FT21039 followed by a 2 day in-clinic period. Receives: Other: FT21039 |
| FT21041 Group | Experimental | 7 day at-home use of electronic cigarette FT21041 followed by a 2 day in-clinic period. Receives: Other: FT21041 |
| FT21044 Group | Experimental | 7 day at-home use of electronic cigarette FT21044 followed by a 2 day in-clinic period. Receives: Other: FT21044 |
| FT21042 Group | Experimental | 7 day at-home use of electronic cigarette FT21042 followed by a 2 day in-clinic period. Receives: Other: FT21042 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum baseline-adjusted nicotine plasma concentration)
To assess nicotine uptake with the start of a 10-minute ad libitum Investigational Product (IP) use period.
Measured: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes
AUCnic0-60
Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 60 minutes after the start of a 10-minute ad libitum IP use period.
Measured: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes
Secondary outcomes (2)
Tmax and AUCnic0-15
Maximum baseline-adjusted plasma nicotine concentration and area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 15 minutes after the start of IP use.
Measured: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
PLoverall
Overall product liking (PL) is an additional measure of how much the subject likes the product, and is indicative of their potential willingness to seek out use of the product again at a later point in time; measured 13 minutes after the start of IP use.
Measured: 13 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start29 Mar 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated, Davita Clinical Research
- Responsible party
- Sponsor
- Investigators
- Frank Lee, MD, Principal investigator, Inflamax Research IncorporatedMargarita Nunez, MD, Principal investigator, High Point Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105804
- Sponsor's protocol ID
- CSD170301
- Status last verified
- Apr 2018
- First submitted
- 4 Apr 2017
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD170301: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Electronic Cigarettes
- ClinicalTrials.gov ID
- NCT03105804
- Acronym / sponsor ID
- CSD170301
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated, Davita Clinical Research
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 10 Apr 2017 (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.
To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four different marketed electronic cigarettes. Furthermore, to measure overall product liking by subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in the future.
Detailed description
This will be a single-center, randomized, open-label, parallel study during which up to 140 healthy adult subjects, consisting of 35 subjects per marketed EC product, will be enrolled. Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The study will involve the use of four (4) marketed EC products in tobacco consumers who are exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e., intermittent EC users).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FT21039 Group | Experimental | Other: FT210397 day at-home use of electronic cigarette FT21039 followed by a 2 day in-clinic period. |
| FT21041 Group | Experimental | Other: FT210417 day at-home use of electronic cigarette FT21041 followed by a 2 day in-clinic period. |
| FT21044 Group | Experimental | Other: FT210447 day at-home use of electronic cigarette FT21044 followed by a 2 day in-clinic period. |
| FT21042 Group | Experimental | Other: FT210427 day at-home use of electronic cigarette FT21042 followed by a 2 day in-clinic period. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
- Generally healthy males and females, 21 to 60 years of age, inclusive, at Screening Visit.
- Subjects must meet one (a or b) of the following tobacco use conditions:
- Willing to be confined overnight and abstain from tobacco- and nicotine- containing product use for 12 hours prior to IP use through Study Discharge.
- Willing to use assigned IP during the study according to protocol.
Key exclusion criteria (17 listed)
- Presence of clinically significant or unstable/uncontrolled acute or chronic medical conditions at the Screening Visit, as determined by the Investigator, that would preclude a subject from participating safely in the study (e.g., uncontrolled hypertension, diabetes, asthma or other lung disease, cardiac disease, neurological disease or psychiatric disorders) based on safety assessments such as clinical laboratory tests, pregnancy tests, medical history, and physical/oral examinations.
- At risk for heart disease, as determined by the Investigator.
- Systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥ 95 mmHg, measured after being seated for 5 minutes.
- Weight of ≤ 110 pounds.
- Poor peripheral venous access.
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 |
|---|---|---|
| FT21039An electronic cigarette | Other | FT21039 Group |
| FT21041An electronic cigarette | Other | FT21041 Group |
| FT21044An electronic cigarette | Other | FT21044 Group |
| FT21042An electronic cigarette | Other | FT21042 Group |
Primary outcome
Cmax (Maximum baseline-adjusted nicotine plasma concentration)
Time frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes
To assess nicotine uptake with the start of a 10-minute ad libitum Investigational Product (IP) use period.
AUCnic0-60
Time frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes
Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 60 minutes after the start of a 10-minute ad libitum IP use period.
2 secondary outcomes
Tmax and AUCnic0-15
Time frame: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
PLoverall
Time frame: 13 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 10 Apr 2018.
- 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.
Frank Lee, MD principal investigator
Inflamax Research Incorporated
Margarita Nunez, MD principal investigator
High Point Clinical Trial Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FT21039, FT21041 and FT21044 in people with Smoking, run by RAI Services Company at 2 sites 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 11 inclusion and 17 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 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Cmax (Maximum baseline-adjusted nicotine plasma concentration) (time frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 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?
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 10 Apr 2018.