SmokingNCT04529551
CSD1601: A Study to Evaluate the Exposure to Tar and Nicotine From Two Cigarette Products That Contain a Menthol Capsule in the Filter
A study testing 1601A and 1601B in people with Smoking and Tobacco 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 cigarette products that contain a menthol capsule in the filter, and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette products. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco Smoking, Tobacco Use
- What is being tested?
- 1601A and 1601B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2016to 2 May 2016
- 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) written in English;
- 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;
- Subject does not intend to delay a decision to quit smoking to participate in the study.
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- 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.
United States1 site
High Point Clinical Trials Center
High Point, North Carolina, 27265
About this study
Official title: CSD1601: A Crossover Study to Evaluate the Exposure to Tar and Nicotine From Two Cigarette Products That Contain a Menthol Capsule in the Filter
This study will evaluate exposure to tar and nicotine from two cigarette products that contain a menthol capsule in the filter, and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette products.
Read the detailed description
Subjects will be randomly assigned to the order in which they will smoke two study 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 Yield-in-Use (YIU) tar and nicotine levels. Blood samples will be collected at each test visit for determination of blood 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, Tobacco Smoking, Tobacco Use
- Being tested
- 1601A, 1601B
- Medical subject headings
- Smoking, Tobacco Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1601AOther
A filtered, king size cigarette with a menthol capsule in the filter.
1601BOther
A filtered, king size cigarette with a menthol capsule in the filter.
| Study group | Role | What they receive |
|---|---|---|
| 1601A, 1601B product use order | Experimental | Subjects will use 1601A for 1 week and then 1601B for 1 week. Receives: Other: 1601A; Other: 1601B |
| 1601B, 1601A product use order | Experimental | Subjects will use 1601B for 1 week and then 1601A for 1 week. Receives: Other: 1601A; Other: 1601B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yield-in-use tar per cigarette
To compare the per cigarette YIU tar per cigarette from smoking product 1601A with those from smoking product 1601B.
Measured: 2 weeks
Yield-in-use nicotine per cigarette
To compare the per cigarette YIU nicotine per cigarette from smoking product 1601A with those from smoking product 1601B.
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 posted27 Aug 2020
- Study start8 Apr 2016
- Primary completion2 May 2016
- Study completion2 May 2016
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Austin, MD, Principal investigator, High Point Clinical Trials Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529551
- Sponsor's protocol ID
- CSD1601
- Status last verified
- Jun 2022
- First submitted
- 24 Aug 2020
- Last updated
- 27 Jun 2022
- 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 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD1601: A Crossover Study to Evaluate the Exposure to Tar and Nicotine From Two Cigarette Products That Contain a Menthol Capsule in the Filter
- ClinicalTrials.gov ID
- NCT04529551
- Acronym / sponsor ID
- CSD1601
- Conditions
- Smoking, Tobacco Smoking, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2016 (actual)
- Primary completion
- 2 May 2016 (actual)
- Study completion
- 2 May 2016 (actual)
- First posted
- 27 Aug 2020 (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 cigarette products that contain a menthol capsule in the filter, and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette products.
Detailed description
Subjects will be randomly assigned to the order in which they will smoke two study 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 Yield-in-Use (YIU) tar and nicotine levels. Blood samples will be collected at each test visit for determination of blood 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 |
|---|---|---|
| 1601A, 1601B product use order | Experimental | Other: 1601A, Other: 1601BSubjects will use 1601A for 1 week and then 1601B for 1 week. |
| 1601B, 1601A product use order | Experimental | Other: 1601A, Other: 1601BSubjects will use 1601B for 1 week and then 1601A for 1 week. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to read, understand, and willing to sign an Informed Consent Form (ICF) written in English;
- 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 |
|---|---|---|
| 1601AA filtered, king size cigarette with a menthol capsule in the filter. | Other | 1601A, 1601B product use order, 1601B, 1601A product use order |
| 1601BA filtered, king size cigarette with a menthol capsule in the filter. | Other | 1601A, 1601B product use order, 1601B, 1601A product use order |
Primary outcome
Yield-in-use tar per cigarette
Time frame: 2 weeks
To compare the per cigarette YIU tar per cigarette from smoking product 1601A with those from smoking product 1601B.
Yield-in-use nicotine per cigarette
Time frame: 2 weeks
To compare the per cigarette YIU nicotine per cigarette from smoking product 1601A with those from smoking product 1601B.
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 27 Jun 2022.
- 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.
Jonathan Austin, MD principal investigator
High Point Clinical Trials Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1601A and 1601B in people with Smoking and Tobacco 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 9 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 27 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?
Yield-in-use tar per cigarette (time frame: 2 weeks). 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 27 Jun 2022.