SmokingNCT03294356
CSD170304: Study to Assess Nicotine Uptake in Smokers From Electronic and Combustible Cigarettes
A study testing FT210771, FT210751 and 6T30134157764 in people with Smoking, run by RAI Services Company at 5 sites in United States.
Trial summary
To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of five different marketed electronic cigarettes, or one combustible cigarette (CC). 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?
- FT210771, FT210751 and 6T30134157764
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Sep 2017to 2 Nov 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 ≥ 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 Principal Investigator (PI).
- Dual user of CCs and ECs who self-reports:
- Smoking ≥ 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 PI; and ii. 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.
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- Willing to be confined overnight and abstain from tobacco- and nicotine-containing product use (with the exception of study IP use) for 12 hours prior to IP use through Study Discharge.
- 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 PI 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 condition at the Screening Visit, as determined by the PI, that would preclude a subject from participating safely in the study (e.g.,, uncontrolled hypertension, chronic 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 PI.
- Systolic blood pressure of > 160 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, unless on a stable dose for the past 6 months prior to screening and deemed clinically stable by the PI.
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- Current on scheduled treatment(s) for asthma within the past consecutive 12 months prior to screening. If potential subject is on an as-needed treatment, such as rescue inhalers, subject may be included at the PI's discretion pending approval from the Medical Monitor.
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically or cryogenically removed.
- 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®], 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 or who 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 prescribed corresponding concomitant medication(s) at the Screening Visit or on Study Day 1.
- A positive alcohol breathalyzer result at the Screening Visit or on Study Day 1.
- Employed by a tobacco or nicotine-manufacturing company, the study site, or handles tobacco or nicotine-containing products as part of their job.
- Determined by the PI 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Midwest Clinical Research (MCRC)
Dayton, Ohio, 45417
New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, 37920
Central Kentucky Research Associates (CKRA)
Lexington, Kentucky, 40509
St. Louis Clinical Trials (SLCT)
St Louis, Missouri, 63141
Clinical Research Consortium (CRC)
Tempe, Arizona, 85283
About this study
Official title: CSD170304: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Electronic and Combustible Cigarettes
To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of five different marketed electronic cigarettes, or one combustible cigarette (CC). 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 210 healthy adult subjects, consisting of 35 subjects per product group, will be enrolled. Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The study will involve the use of five different marketed ECs or one CC 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
- FT210771, FT210751, 6T30134157764, G41A7C071, M011161212
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT210771Other
An electronic cigarette
FT210751Other
An electronic cigarette
6T30134157764Other
An electronic cigarette
G41A7C071Other
An electronic cigarette
M011161212Other
An electronic cigarette
FT21002Other
A combustible cigarette
| Study group | Role | What they receive |
|---|---|---|
| FT210771 Group | Experimental | 7 day at-home use of electronic cigarette FT210771 followed by a 2 day in-clinic period. Receives: Other: FT210771 |
| FT210751 Group | Experimental | 7 day at-home use of electronic cigarette FT210751 followed by a 2 day in-clinic period. Receives: Other: FT210751 |
| 6T30134157764 Group | Experimental | 7 day at-home use of electronic cigarette 6T30134157764 followed by a 2 day in-clinic period. Receives: Other: 6T30134157764 |
| G41A7C071 Group | Experimental | 7 day at-home use of electronic cigarette G41A7C071 followed by a 2 day in-clinic period. Receives: Other: G41A7C071 |
| M011161212 Group | Experimental | 7 day at-home use of electronic cigarette M011161212 followed by a 2 day in-clinic period. Receives: Other: M011161212 |
| FT21002 Group | Experimental | 7 day at-home use of combustible cigarette FT21002 followed by a 2 day in-clinic period. Receives: Other: FT21002 |
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 (3)
Tmax
Maximum baseline-adjusted plasma nicotine concentration from time zero to 15 minutes after the start of IP use.
Measured: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
AUCnic0-15
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 posted27 Sep 2017
- Study start13 Sep 2017
- Primary completion2 Nov 2017
- Study completion2 Nov 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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Corey Anderson, MD, Principal investigator, Clinical Research Consortium (CRC)Mark Adams, MD, Principal investigator, Central Kentucky Research Associates (CKRA)Daniel Gruener, MD, Principal investigator, St. Louis Clinical Trials (SLCT)Otto Dueno, MD, Principal investigator, Midwest Clinical Research (MCRC)William Smith, MD, Principal investigator, New Orleans Center for Clinical Research (NOCCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294356
- Sponsor's protocol ID
- CSD170304
- Status last verified
- Nov 2017
- First submitted
- 22 Sep 2017
- Last updated
- 14 Nov 2017
- 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 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD170304: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Electronic and Combustible Cigarettes
- ClinicalTrials.gov ID
- NCT03294356
- Acronym / sponsor ID
- CSD170304
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 27 Sep 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 five different marketed electronic cigarettes, or one combustible cigarette (CC). 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 210 healthy adult subjects, consisting of 35 subjects per product group, will be enrolled. Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The study will involve the use of five different marketed ECs or one CC 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
- 6
| Arm | Type | Receives |
|---|---|---|
| FT210771 Group | Experimental | Other: FT2107717 day at-home use of electronic cigarette FT210771 followed by a 2 day in-clinic period. |
| FT210751 Group | Experimental | Other: FT2107517 day at-home use of electronic cigarette FT210751 followed by a 2 day in-clinic period. |
| 6T30134157764 Group | Experimental | Other: 6T301341577647 day at-home use of electronic cigarette 6T30134157764 followed by a 2 day in-clinic period. |
| G41A7C071 Group | Experimental | Other: G41A7C0717 day at-home use of electronic cigarette G41A7C071 followed by a 2 day in-clinic period. |
| M011161212 Group | Experimental | Other: M0111612127 day at-home use of electronic cigarette M011161212 followed by a 2 day in-clinic period. |
| FT21002 Group | Experimental | Other: FT210027 day at-home use of combustible cigarette FT21002 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 (12 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 (with the exception of study IP 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 (19 listed)
- Presence of clinically significant or unstable/uncontrolled acute or chronic medical condition at the Screening Visit, as determined by the PI, that would preclude a subject from participating safely in the study (e.g.,, uncontrolled hypertension, chronic 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 PI.
- Systolic blood pressure of > 160 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 |
|---|---|---|
| FT210771An electronic cigarette | Other | FT210771 Group |
| FT210751An electronic cigarette | Other | FT210751 Group |
| 6T30134157764An electronic cigarette | Other | 6T30134157764 Group |
| G41A7C071An electronic cigarette | Other | G41A7C071 Group |
| M011161212An electronic cigarette | Other | M011161212 Group |
| FT21002A combustible cigarette | Other | FT21002 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.
3 secondary outcomes
Tmax
Time frame: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
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 14 Nov 2017.
- 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.
Corey Anderson, MD principal investigator
Clinical Research Consortium (CRC)
Mark Adams, MD principal investigator
Central Kentucky Research Associates (CKRA)
Daniel Gruener, MD principal investigator
St. Louis Clinical Trials (SLCT)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FT210771, FT210751 and 6T30134157764 in people with Smoking, run by RAI Services Company at 5 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 12 inclusion and 19 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 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 14 Nov 2017.