SmokingNCT03063047
CSD1603: A Crossover Study to Evaluate the Exposure to "Tar" and Nicotine From 100s Menthol Cigarette Products
A study testing PD21871AA and PD21872AA in people with Smoking, run by RAI Services Company at 1 site in United States.
Trial summary
This study will evaluate exposure to "tar" and nicotine from two menthol cigarette products and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette products. Mouth-level exposure is the measurement of substance trapped in the cigarette butt after smoking the cigarette. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- PD21871AA and PD21872AA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2017to 13 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read, understand, and willing to sign an Informed Consent Form (ICF).
- Generally healthy males and females, 21 years of age or older, at Screening-Enrollment Visit.
- Self-reports smoking at least seven cigarettes per day and inhaling the smoke.
- Usual brand of cigarette is one of the brand styles specified.
- Smoked usual brand for ≥ 3 months.
- Agrees to exclusively smoke the study cigarettes and not smoke or use any other tobacco or nicotine-containing products during the course of the study.
- Able to read and comprehend English.
- Able to safely perform the required study procedures, as determined by the Investigator.
Who cannot join
- Self-reported history of heart disease, kidney disease, asthma or any other lung disease, diabetes, liver disease, hypertension, or hypercholesterolemia.
- At risk for heart disease, i.e., obesity (body mass index [BMI] ≥ 40 kg/m2), as determined by the Investigator.
- Females ≥ 35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy.
- Postponing a decision to quit smoking (defined as planning a quit attempt within 30 days of the Screening-Enrollment Visit) to participate in this study.
- 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-Enrollment Visit.
- Females who test positive for pregnancy, are pregnant or breastfeeding, or plan to become pregnant during the course of the study.
- Determined by the Investigator to be inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate exposure to "tar" and nicotine from two menthol cigarette products and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette products. Mouth-level exposure is the measurement of substance trapped in the cigarette butt after smoking the cigarette.
Other purposes of this study are to:
- Compare the plasma cotinine, a byproduct of your body's processing of nicotine, levels found in users after smoking each of two different cigarettes.
- Find out the daily mouth-level exposure to cigarette "tar" and nicotine from smoking each of two different cigarettes in adult smokers.
- Determine if certain measures of nicotine dependence change based on the type of cigarette smoked
- To compare product liking and intent to use it again.
Read the detailed description
The study will consist of one group of approximately 32 adult subjects randomly assigned to the order in which they will smoke two study menthol cigarette products (including one comparator product and one test product). Subjects will smoke each study product exclusively for approximately one week prior to a test visit, with a different product smoked each week over a two-week period. Cigarette butts will be collected the day prior to each test visit for determination of MLE "tar" and nicotine levels. Blood samples will be collected at each test visit for determination of plasma cotinine levels. Subjects will provide responses to questions during each test visit to assess their cigarette smoking and cigarette butt collection behavior during the preceding day.
- Conditions
- Smoking
- Being tested
- PD21871AA, PD21872AA
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD21871AAOther
A 100s size menthol cigarette.
PD21872AAOther
A 100s size menthol cigarette.
| Study group | Role | What they receive |
|---|---|---|
| PD21871AA, PD21872AA | Active comparator | Subjects will use PD21871AA for 1 week and then PD21872AA for 1 week. Receives: Other: PD21871AA; Other: PD21872AA |
| PD21872AA, PD21871AA | Active comparator | Subjects will use PD21872AA for 1 week and then PD21871AA for 1 week. Receives: Other: PD21871AA; Other: PD21872AA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth-level exposure (MLE) "tar" per cigarette and MLE nicotine per cigarette.
To compare the per cigarette MLE parameters (MLE "tar" per cigarette and MLE nicotine per cigarette) from smoking PD21871AA with those from smoking PD21872AA in adult smokers.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start6 Feb 2017
- Primary completion13 Mar 2017
- Study completion13 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Davita Clinical Research
- Responsible party
- Sponsor
- Investigators
- Elizabeth Yoon, FNP-C, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063047
- Sponsor's protocol ID
- CSD1603
- Status last verified
- Mar 2017
- First submitted
- 20 Feb 2017
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
St Charles FK, Kabbani AA, Borgerding MF. Estimating tar and nicotine exposure: human smoking versus machine generated smoke yields. Regul Toxicol Pharmacol. 2010 Feb;56(1):100-10. doi: 10.1016/j.yrtph.2009.08.011. Epub 2009 Aug 31.
PubMed 19723554Fagerstrom K. Determinants of tobacco use and renaming the FTND to the Fagerstrom Test for Cigarette Dependence. Nicotine Tob Res. 2012 Jan;14(1):75-8. doi: 10.1093/ntr/ntr137. Epub 2011 Oct 24. No abstract available.
PubMed 22025545Shepperd CJ, St Charles FK St, Lien M, Dixon M . Validation of methods for determining consumer smoked cigarette yields from cigarette filter analysis. Beitr Tabakforsch Int. 2006;22:176-184.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD1603: A Crossover Study to Evaluate the Exposure to "Tar" and Nicotine From 100s Menthol Cigarette Products
- ClinicalTrials.gov ID
- NCT03063047
- Acronym / sponsor ID
- CSD1603
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Davita Clinical Research
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 13 Mar 2017 (actual)
- Study completion
- 13 Mar 2017 (actual)
- First posted
- 24 Feb 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.
This study will evaluate exposure to "tar" and nicotine from two menthol cigarette products and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette products. Mouth-level exposure is the measurement of substance trapped in the cigarette butt after smoking the cigarette.
Other purposes of this study are to:
- Compare the plasma cotinine, a byproduct of your body's processing of nicotine, levels found in users after smoking each of two different cigarettes.
- Find out the daily mouth-level exposure to cigarette "tar" and nicotine from smoking each of two different cigarettes in adult smokers.
- Determine if certain measures of nicotine dependence change based on the type of cigarette smoked
- To compare product liking and intent to use it again.
Detailed description
The study will consist of one group of approximately 32 adult subjects randomly assigned to the order in which they will smoke two study menthol cigarette products (including one comparator product and one test product). Subjects will smoke each study product exclusively for approximately one week prior to a test visit, with a different product smoked each week over a two-week period. Cigarette butts will be collected the day prior to each test visit for determination of MLE "tar" and nicotine levels. Blood samples will be collected at each test visit for determination of plasma cotinine levels. Subjects will provide responses to questions during each test visit to assess their cigarette smoking and cigarette butt collection behavior during the preceding day.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD21871AA, PD21872AA | Active comparator | Other: PD21871AA, Other: PD21872AASubjects will use PD21871AA for 1 week and then PD21872AA for 1 week. |
| PD21872AA, PD21871AA | Active comparator | Other: PD21871AA, Other: PD21872AASubjects will use PD21872AA for 1 week and then PD21871AA for 1 week. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to read, understand, and willing to sign an Informed Consent Form (ICF).
- Generally healthy males and females, 21 years of age or older, at Screening-Enrollment Visit.
- Self-reports smoking at least seven cigarettes per day and inhaling the smoke.
- Usual brand of cigarette is one of the brand styles specified.
- Smoked usual brand for ≥ 3 months.
Key exclusion criteria (7 listed)
- Self-reported history of heart disease, kidney disease, asthma or any other lung disease, diabetes, liver disease, hypertension, or hypercholesterolemia.
- At risk for heart disease, i.e., obesity (body mass index [BMI] ≥ 40 kg/m2), as determined by the Investigator.
- Females ≥ 35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy.
- Postponing a decision to quit smoking (defined as planning a quit attempt within 30 days of the Screening-Enrollment Visit) to participate in this study.
- 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-Enrollment Visit.
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 |
|---|---|---|
| PD21871AAA 100s size menthol cigarette. | Other | PD21871AA, PD21872AA, PD21872AA, PD21871AA |
| PD21872AAA 100s size menthol cigarette. | Other | PD21871AA, PD21872AA, PD21872AA, PD21871AA |
Primary outcome
Mouth-level exposure (MLE) "tar" per cigarette and MLE nicotine per cigarette.
Time frame: 2 weeks
To compare the per cigarette MLE parameters (MLE "tar" per cigarette and MLE nicotine per cigarette) from smoking PD21871AA with those from smoking PD21872AA in adult smokers.
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 Mar 2017.
- Background: PubMed 19723554St Charles FK, Kabbani AA, Borgerding MF. Estimating tar and nicotine exposure: human smoking versus machine generated smoke yields. Regul Toxicol Pharmacol. 2010 Feb;56(1):100-10. doi: 10.1016/j.yrtph.2009.08.011. Epub 2009 Aug 31.
- Background: PubMed 22025545Fagerstrom K. Determinants of tobacco use and renaming the FTND to the Fagerstrom Test for Cigarette Dependence. Nicotine Tob Res. 2012 Jan;14(1):75-8. doi: 10.1093/ntr/ntr137. Epub 2011 Oct 24. No abstract available.
- BackgroundShepperd CJ, St Charles FK St, Lien M, Dixon M . Validation of methods for determining consumer smoked cigarette yields from cigarette filter analysis. Beitr Tabakforsch Int. 2006;22:176-184.
- 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.
Elizabeth Yoon, FNP-C principal investigator
Davita Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PD21871AA and PD21872AA in people with Smoking, run by RAI Services Company 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 8 inclusion and 7 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 Mar 2017. 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?
Mouth-level exposure (MLE) "tar" per cigarette and MLE nicotine per cigarette. (time frame: 2 weeks). 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 NCT03063047, which also lists 3 linked publications.
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 Mar 2017; AzTrials last refreshed its copy on 30 Oct 2026.