SmokingNCT05118139
CSD201203: A Study to Determine Subject Puffing Patterns of a Non-cylindrical, Closed, Electronic Nicotine Delivery System at Three Nicotine Concentrations in an Ambulatory Setting
A study testing P1211216, P1213416 and P1213716 in people with Smoking and Tobacco Use, run by RAI Services Company at 4 sites in United States.
Trial summary
This is a multi-center, open-label, parallel, three-study-group investigation to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to the ENDS Investigational Product (IP), over a 9-day ambulatory period. 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 Use, Electronic Cigarette Use
- What is being tested?
- P1211216, P1213416 and P1213716
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Feb 2022to 30 Jul 2022
- 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) and complete questionnaires written in English.
- Generally healthy male or female adults, ≥ 21 years of age, inclusive, at the time of consent.
- Positive urine cotinine test at the Screening Visit.
- Non-cylindrical, cartridge-based, closed-system ENDS are the primary form of tobacco- or nicotine-containing products used within 30 days of the Screening Visit. Subjects may be users of other tobacco- or nicotine-containing products. If the subject is a dual/poly user of tobacco- or /nicotine-containing products then the subject must self-report that a non-cylindrical, cartridge-based, closed-system ENDS is their primary product.
- Must have used 2 or more cartridges per week over the last 30 days. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of the Screening Visit), or clinical study participation (prior to 30 days of the Screening Visit) will be allowed at the discretion of the Principal Investigator (PI).
- Females must be willing to use a form of contraception acceptable to the PI from the time of signing the ICF until the end of the study.
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- Must be willing to use the assigned IP and only the assigned flavor as their exclusive source of ENDS use for the full duration of the 9-day ambulatory period. Use of other non-ENDS tobacco- or nicotine-containing products will be permitted during the ambulatory period.
- Must have familiarity with modern electronic devices such as an IOS/Android smart phone or tablet computer ("tablet") and be willing to be provided with an electronic device, that allows for both Bluetooth connectivity and internet connectivity. Must be willing to use an application on the electronic device and keep the application active for the length of the study
- Able to safely perform the required study procedures, as determined by the PI.
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 of or presence of diabetes.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes, with exceptions at the PI's discretion.
- 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.
- 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 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 signing the ICF.
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- Participation in another clinical trial within (≤) 30 days prior to signing the ICF unless allowed at the discretion of the Principal Investigator (PI). 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, or who are pregnant, are 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 the Screening or Enrollment Visits.
- 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 signing the ICF.
- Drinks more than 21 servings of alcoholic beverages per week or has a positive test for alcohol result at the Screening or Enrollment Visits.
- 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 this study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Accellacare Hickory
Hickory, North Carolina, 28601
High Point Clinical Trials Center
High Point, North Carolina, 27265
AMR Lexington
Lexington, Kentucky, 40509
Clinical Research Atlanta
Stockbridge, Georgia, 30281
About this study
This is a multi-center, open-label, parallel, three-study-group investigation to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to the ENDS Investigational Product (IP), over a 9-day ambulatory period.
Read the detailed description
Potential subjects may complete a pre-screening interview and will complete a Screening Visit to assess their eligibility. Based on meeting eligibility requirements, subjects will be enrolled into the study either on the same day of their Screening Visit or return to the clinic on another day to complete the Enrollment Visit.
Subjects will be assigned to one of three nicotine concentrations of the IP based on their scheduled Enrollment Visit to the clinic. Once enrolled, the subjects will be assigned to one of the flavor variants of the IP after sampling or trying flavors, within the assigned nicotine concentration, and determining which flavor that they would like to use for the length of the study. Once a particular flavor group has reached full enrollment, that flavor will no longer be available for sampling and selection. Subjects will be instructed not to use their UB ENDS products during the study.
At the Enrollment Visit, subjects will be provided a Power Unit, Cartridges for their assigned product, a Product Use and Behavior (PUB) instrument, and an electronic device. The electronic device will have the PUB application installed for topography data capture and PUB data transmission. Based upon their UB ENDS usage, subjects will be given a sufficient amount of their assigned IP cartridges.
Subjects will be instructed to use their assigned IP in place of their UB ENDS during the 9-day study period (including a 2-day IP acclimation period followed by a 7-day product use evaluation period). Subjects will be allowed to use non-ENDS tobacco- or nicotine-containing products according to their normal use pattern. The PUB instrument will collect puffing topography data throughout the product use period.
At the end of the 2-day IP acclimation period, subjects will receive a phone call from the clinic to assess IP compliance and to ensure that they are not using their UB ENDS. During the following Days 3-9 evaluation period, subjects will receive a phone call to remind them of guidelines for using their assigned IP and to document adverse events (AEs).
At the conclusion of the 9-day ambulatory period, the subjects will return to the clinic, return the Power Unit, any associated Accessory USB Charger, all used and unused IP cartridges, the corresponding PUB instrument and its charger, and the electronic device. Each subject will complete all End of Study procedures including completing the Product Evaluation Scale (PES) questionnaire and two additional questionnaires to assess the degree of overall product liking and intention to use the product. The subjects will then be discharged from the study.
- Conditions
- Smoking, Tobacco Use, Electronic Cigarette Use
- Being tested
- P1211216, P1213416, P1213716, P1213616, P1213816
- Medical subject headings
- Smoking, Tobacco Use, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1211216Other
Flavor variant P1211216 of a 1.5% nicotine ENDS product
P1213416Other
Flavor variant P1213416 of a 1.5% nicotine ENDS product
P1213716Other
Flavor variant P1213716 of a 1.5% nicotine ENDS product
P1213616Other
Flavor variant P1213616 of a 1.5% nicotine ENDS product
P1213816Other
Flavor variant P1213816 of a 1.5% nicotine ENDS product
P1211916Other
Flavor variant P1211916 of a 1.5% nicotine ENDS product
P1210016Other
Flavor variant P1210016 of a 1.5% nicotine ENDS product
P1211217Other
Flavor variant P1211217 of a 2.4% nicotine ENDS product
P1213417Other
Flavor variant P1213417 of a 2.4% nicotine ENDS product
P1211222Other
Flavor variant P1211222 of a 5% nicotine ENDS product
P1213422Other
Flavor variant P1213422 of a 5% nicotine ENDS product
P1213722Other
Flavor variant P1213722 of a 5% nicotine ENDS product
P1213622Other
Flavor variant P1213622 of a 5% nicotine ENDS product
P1213822Other
Flavor variant P1213822 of a 5% nicotine ENDS product
P1211922Other
Flavor variant P1211922 of a 5% nicotine ENDS product
P1210022Other
Flavor variant P1210022 of a 5% nicotine ENDS product
| Study group | Role | What they receive |
|---|---|---|
| 1.5% nicotine cartridges | Experimental | Subjects will self-assign to one of 7 flavor variants of 1.5% ENDS products based on their preferred flavor. Receives: Other: P1211216; Other: P1213416; Other: P1213716; Other: P1213616; Other: P1213816; Other: P1211916; Other: P1210016 |
| 2.4% nicotine cartridges | Experimental | Subjects will self-assign to one of 2 flavor variants of 2.4% ENDS products based on their preferred flavor. Receives: Other: P1211217; Other: P1213417 |
| 5% nicotine cartridges | Experimental | Subjects will self-assign to one of 7 flavor variants of 5% ENDS products based on their preferred flavor. Receives: Other: P1211222; Other: P1213422; Other: P1213722; Other: P1213622; Other: P1213822; Other: P1211922; Other: P1210022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puff duration
Average puff duration
Measured: Final 7 days of data collection
Number of puff per day
Average number of puffs per day
Measured: Final 7 days of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start11 Feb 2022
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Dull, PhD, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118139
- Sponsor's protocol ID
- CSD201203
- Status last verified
- Apr 2025
- First submitted
- 1 Nov 2021
- Last updated
- 10 Apr 2025
- 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 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD201203: A Study to Determine Subject Puffing Patterns of a Non-cylindrical, Closed, Electronic Nicotine Delivery System at Three Nicotine Concentrations in an Ambulatory Setting
- ClinicalTrials.gov ID
- NCT05118139
- Acronym / sponsor ID
- CSD201203
- Conditions
- Smoking, Tobacco Use, Electronic Cigarette Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 11 Nov 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 a multi-center, open-label, parallel, three-study-group investigation to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to the ENDS Investigational Product (IP), over a 9-day ambulatory period.
Detailed description
Potential subjects may complete a pre-screening interview and will complete a Screening Visit to assess their eligibility. Based on meeting eligibility requirements, subjects will be enrolled into the study either on the same day of their Screening Visit or return to the clinic on another day to complete the Enrollment Visit.
Subjects will be assigned to one of three nicotine concentrations of the IP based on their scheduled Enrollment Visit to the clinic. Once enrolled, the subjects will be assigned to one of the flavor variants of the IP after sampling or trying flavors, within the assigned nicotine concentration, and determining which flavor that they would like to use for the length of the study. Once a particular flavor group has reached full enrollment, that flavor will no longer be available for sampling and selection. Subjects will be instructed not to use their UB ENDS products during the study.
At the Enrollment Visit, subjects will be provided a Power Unit, Cartridges for their assigned product, a Product Use and Behavior (PUB) instrument, and an electronic device. The electronic device will have the PUB application installed for topography data capture and PUB data transmission. Based upon their UB ENDS usage, subjects will be given a sufficient amount of their assigned IP cartridges.
Subjects will be instructed to use their assigned IP in place of their UB ENDS during the 9-day study period (including a 2-day IP acclimation period followed by a 7-day product use evaluation period). Subjects will be allowed to use non-ENDS tobacco- or nicotine-containing products according to their normal use pattern. The PUB instrument will collect puffing topography data throughout the product use period.
At the end of the 2-day IP acclimation period, subjects will receive a phone call from the clinic to assess IP compliance and to ensure that they are not using their UB ENDS. During the following Days 3-9 evaluation period, subjects will receive a phone call to remind them of guidelines for using their assigned IP and to document adverse events (AEs).
At the conclusion of the 9-day ambulatory period, the subjects will return to the clinic, return the Power Unit, any associated Accessory USB Charger, all used and unused IP cartridges, the corresponding PUB instrument and its charger, and the electronic device. Each subject will complete all End of Study procedures including completing the Product Evaluation Scale (PES) questionnaire and two additional questionnaires to assess the degree of overall product liking and intention to use the product. The subjects will then be discharged from the study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.5% nicotine cartridges | Experimental | Other: P1211216, Other: P1213416, Other: P1213716, Other: P1213616, Other: P1213816, Other: P1211916, Other: P1210016Subjects will self-assign to one of 7 flavor variants of 1.5% ENDS products based on their preferred flavor. |
| 2.4% nicotine cartridges | Experimental | Other: P1211217, Other: P1213417Subjects will self-assign to one of 2 flavor variants of 2.4% ENDS products based on their preferred flavor. |
| 5% nicotine cartridges | Experimental | Other: P1211222, Other: P1213422, Other: P1213722, Other: P1213622, Other: P1213822, Other: P1211922, Other: P1210022Subjects will self-assign to one of 7 flavor variants of 5% ENDS products based on their preferred flavor. |
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) and complete questionnaires written in English.
- Generally healthy male or female adults, ≥ 21 years of age, inclusive, at the time of consent.
- Positive urine cotinine test at the Screening Visit.
- Non-cylindrical, cartridge-based, closed-system ENDS are the primary form of tobacco- or nicotine-containing products used within 30 days of the Screening Visit. Subjects may be users of other tobacco- or nicotine-containing products. If the subject is a dual/poly user of tobacco- or /nicotine-containing products then the subject must self-report that a non-cylindrical, cartridge-based, closed-system ENDS is their primary product.
- Must have used 2 or more cartridges per week over the last 30 days. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of the Screening Visit), or clinical study participation (prior to 30 days of the Screening Visit) will be allowed at the discretion of the Principal Investigator (PI).
Key exclusion criteria (14 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 of or presence of diabetes.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes, with exceptions at the PI's discretion.
- 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.
- 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.
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 |
|---|---|---|
| P1211216Flavor variant P1211216 of a 1.5% nicotine ENDS product | Other | 1.5% nicotine cartridges |
| P1213416Flavor variant P1213416 of a 1.5% nicotine ENDS product | Other | 1.5% nicotine cartridges |
| P1213716Flavor variant P1213716 of a 1.5% nicotine ENDS product | Other | 1.5% nicotine cartridges |
| P1213616Flavor variant P1213616 of a 1.5% nicotine ENDS product | Other | 1.5% nicotine cartridges |
| P1213816Flavor variant P1213816 of a 1.5% nicotine ENDS product | Other | 1.5% nicotine cartridges |
| P1211916Flavor variant P1211916 of a 1.5% nicotine ENDS product | Other | 1.5% nicotine cartridges |
| P1210016Flavor variant P1210016 of a 1.5% nicotine ENDS product | Other | 1.5% nicotine cartridges |
| P1211217Flavor variant P1211217 of a 2.4% nicotine ENDS product | Other | 2.4% nicotine cartridges |
| P1213417Flavor variant P1213417 of a 2.4% nicotine ENDS product | Other | 2.4% nicotine cartridges |
| P1211222Flavor variant P1211222 of a 5% nicotine ENDS product | Other | 5% nicotine cartridges |
| P1213422Flavor variant P1213422 of a 5% nicotine ENDS product | Other | 5% nicotine cartridges |
| P1213722Flavor variant P1213722 of a 5% nicotine ENDS product | Other | 5% nicotine cartridges |
| P1213622Flavor variant P1213622 of a 5% nicotine ENDS product | Other | 5% nicotine cartridges |
| P1213822Flavor variant P1213822 of a 5% nicotine ENDS product | Other | 5% nicotine cartridges |
| P1211922Flavor variant P1211922 of a 5% nicotine ENDS product | Other | 5% nicotine cartridges |
| P1210022Flavor variant P1210022 of a 5% nicotine ENDS product | Other | 5% nicotine cartridges |
Primary outcome
Puff duration
Time frame: Final 7 days of data collection
Average puff duration
Number of puff per day
Time frame: Final 7 days of data collection
Average number of puffs per day
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 2025.
- 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.
Gary Dull, PhD study director
RAIS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P1211216, P1213416 and P1213716 in people with Smoking and Tobacco Use, run by RAI Services Company at 4 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 9 inclusion and 14 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 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Puff duration (time frame: Final 7 days of data collection). 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 2025.