SmokingNCT04751461
CSD210202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems
A study testing Product A, Product B and Product C in people with Smoking and Smoking Behaviors, run by RAI Services Company at 1 site in United States.
Trial summary
This is an open-label, randomized, 5-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Behaviors, Tobacco Use
- What is being tested?
- Product A, Product B and Product C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2021to 20 Apr 2021
- 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 male or female, 21 to 60 years of age, inclusive, at the time of consent.
- Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
- Positive urine cotinine test at Screening.
- Smokes only filtered, menthol or non-menthol combustible cigarettes, 83 mm to 100 mm in length.
- Agrees to smoke same UB combustible cigarette throughout the study period. UB combustible cigarette is defined as the cigarette brand style currently smoked most frequently by the subject.
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- Smokes at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the Principal Investigator (PI).
- Willing to use only UB combustible cigarette and ENDS during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each Test Session.
- Females must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until End-of-Study.
- Agrees to in-clinic confinement of 7 days and 6 nights.
Who cannot join
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95mmHg, measured after being seated for five minutes.
- Weight of ≤ 110 pounds.
- Hemoglobin level is < 12.5 for females or <13.0 for males g/dL at Screening.
- Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion pending approval from the Medical Monitor.
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- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
- Use of an ENDS or tobacco or nicotine-containing products other than cigarettes (e.g., lozenges, moist snuff) within (≤) 30 days prior to Screening.
- Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to the signing of informed consent.
- History or presence of bleeding or clotting disorders.
- Any use of anticoagulants or aspirin (≥ 325 mg/day).
- Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent.
- Plasma donation within (≤) 7 days prior to the signing of informed consent.
- Plans to donate whole blood or plasma prior to Enrollment and Study Day 1.
- Participation in another clinical trial within (≤) 30 days prior to the signing of informed 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 signing the ICF in the current study.
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or Day 1.
- Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous attempt within (≤) 30 days prior to the signing of the ICF.
- Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol breathalyzer result at Screening or 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 PI to be inappropriate for this study. *Subjects will be advised against scheduling of whole blood or plasma donation following study completion for at least 7 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CSD210202: An Unblinded, Randomized, Crossover, Confinement Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems
This is an open-label, randomized, 5-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers.
Read the detailed description
Potential subjects will complete a pre-screening interview and a Screening Visit to assess their eligibility within 45 days prior to enrollment, randomization and confinement.
Following the Screening Visit, eligible subjects will be scheduled for a check-in and randomization visit. At the check-in and randomization visit, subjects' continued eligibility will be confirmed prior to being randomized to a product use sequence and beginning their 6 nights and 7 days of confinement.
Starting on study Day 1, subject will start a Pre-study ENDS IP Acclimation Period through Day 2. Subjects will be asked to acclimate to each of the ENDS IP at least once, while having access to their usual brand (UB) cigarettes for ad libitum use. Starting on Day 3, subjects will participate in five separate Test Sessions for nicotine PK assessment, one for each ENDS IP. For approximately a half day prior to each respective Test Session (starting on Day 2), subjects will use their assigned ENDS IP for the following day's Test Session at least twice.
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Being tested
- Product A, Product B, Product C, Product D, Product E
- Medical subject headings
- Smoking, Tobacco Use, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product AOther
P0213420, a 1.8% nicotine ENDS product
Product BOther
P0213520, a 1.8% nicotine ENDS product
Product COther
P0211220, a 1.8% nicotine ENDS product
Product DOther
P0211820, a 1.8% nicotine ENDS product
Product EOther
P0213417, a 2.4% nicotine ENDS product
| Study group | Role | What they receive |
|---|---|---|
| Product usage order ABECD | Experimental | Subjects will use each of the 5 products (ABECD) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order BCADE | Experimental | Subjects will use each of the 5 products (BCADE) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order CDBEA | Experimental | Subjects will use each of the 5 products (CDBEA) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order DECAB | Experimental | Subjects will use each of the 5 products (DECAB) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order EADBC | Experimental | Subjects will use each of the 5 products (EADBC) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order DCEBA | Experimental | Subjects will use each of the 5 products (DCEBA) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order EDACB | Experimental | Subjects will use each of the 5 products (EDACB) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order AEBDC | Experimental | Subjects will use each of the 5 products (AEBDC) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order BACED | Experimental | Subjects will use each of the 5 products (BACED) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order CBDAE | Experimental | Subjects will use each of the 5 products (CBDAE) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCnic0-240
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use
Measured: 0 to 240 minutes
Cmax
Maximum baseline-adjusted plasma concentration of nicotine
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start23 Feb 2021
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Hong, MD, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751461
- Sponsor's protocol ID
- CSD210202
- Status last verified
- Jun 2022
- First submitted
- 8 Feb 2021
- Last updated
- 24 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 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD210202: An Unblinded, Randomized, Crossover, Confinement Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems
- ClinicalTrials.gov ID
- NCT04751461
- Acronym / sponsor ID
- CSD210202
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 12 Feb 2021 (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 is an open-label, randomized, 5-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers.
Detailed description
Potential subjects will complete a pre-screening interview and a Screening Visit to assess their eligibility within 45 days prior to enrollment, randomization and confinement.
Following the Screening Visit, eligible subjects will be scheduled for a check-in and randomization visit. At the check-in and randomization visit, subjects' continued eligibility will be confirmed prior to being randomized to a product use sequence and beginning their 6 nights and 7 days of confinement.
Starting on study Day 1, subject will start a Pre-study ENDS IP Acclimation Period through Day 2. Subjects will be asked to acclimate to each of the ENDS IP at least once, while having access to their usual brand (UB) cigarettes for ad libitum use. Starting on Day 3, subjects will participate in five separate Test Sessions for nicotine PK assessment, one for each ENDS IP. For approximately a half day prior to each respective Test Session (starting on Day 2), subjects will use their assigned ENDS IP for the following day's Test Session at least twice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Product usage order ABECD | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products (ABECD) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order BCADE | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products (BCADE) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order CDBEA | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products (CDBEA) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order DECAB | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products (DECAB) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order EADBC | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products (EADBC) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order DCEBA | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products (DCEBA) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order EDACB | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products (EDACB) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order AEBDC | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products (AEBDC) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order BACED | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products (BACED) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order CBDAE | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products (CBDAE) during an evaluation period, followed by a 4 hour Test Session |
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 male or female, 21 to 60 years of age, inclusive, at the time of consent.
- Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
- Positive urine cotinine test at Screening.
- Smokes only filtered, menthol or non-menthol combustible cigarettes, 83 mm to 100 mm in length.
Key exclusion criteria (23 listed)
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95mmHg, measured after being seated for five minutes.
- Weight of ≤ 110 pounds.
- Hemoglobin level is < 12.5 for females or <13.0 for males g/dL at Screening.
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 |
|---|---|---|
| Product AP0213420, a 1.8% nicotine ENDS product | Other | Product usage order ABECD, Product usage order AEBDC, Product usage order BACED, Product usage order BCADE, Product usage order CBDAE, Product usage order CDBEA, Product usage order DCEBA, Product usage order DECAB, Product usage order EADBC, Product usage order EDACB |
| Product BP0213520, a 1.8% nicotine ENDS product | Other | Product usage order ABECD, Product usage order AEBDC, Product usage order BACED, Product usage order BCADE, Product usage order CBDAE, Product usage order CDBEA, Product usage order DCEBA, Product usage order DECAB, Product usage order EADBC, Product usage order EDACB |
| Product CP0211220, a 1.8% nicotine ENDS product | Other | Product usage order ABECD, Product usage order AEBDC, Product usage order BACED, Product usage order BCADE, Product usage order CBDAE, Product usage order CDBEA, Product usage order DCEBA, Product usage order DECAB, Product usage order EADBC, Product usage order EDACB |
| Product DP0211820, a 1.8% nicotine ENDS product | Other | Product usage order ABECD, Product usage order AEBDC, Product usage order BACED, Product usage order BCADE, Product usage order CBDAE, Product usage order CDBEA, Product usage order DCEBA, Product usage order DECAB, Product usage order EADBC, Product usage order EDACB |
| Product EP0213417, a 2.4% nicotine ENDS product | Other | Product usage order ABECD, Product usage order AEBDC, Product usage order BACED, Product usage order BCADE, Product usage order CBDAE, Product usage order CDBEA, Product usage order DCEBA, Product usage order DECAB, Product usage order EADBC, Product usage order EDACB |
Primary outcome
AUCnic0-240
Time frame: 0 to 240 minutes
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use
Cmax
Time frame: 240 minutes
Maximum baseline-adjusted plasma concentration of nicotine
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 24 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.
Jason Hong, MD study director
RAIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product A, Product B and Product C in people with Smoking and Smoking Behaviors, 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 11 inclusion and 23 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 24 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?
AUCnic0-240 (time frame: 0 to 240 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 24 Jun 2022.