SmokingNCT04226404
CSD190501: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting
A study testing CSD1905-11, CSD1905-12 and CSD1905-13 in people with Smoking and Smoking Behaviors, run by RAI Services Company at 1 site in United States.
Trial summary
This study will be a single-center, controlled, open-label, parallel study 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 an ENDS Investigational Product (IP) product with 4.8% nicotine over a… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Behaviors, Tobacco Use
- What is being tested?
- CSD1905-11, CSD1905-12 and CSD1905-13
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 27 Feb 2020
- 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, ≥21 years of age, inclusive, at the time of consent.
- Positive urine cotinine test at Screening.
- Cartridge-based, closed-system ENDS are the primary form of tobacco/nicotine-containing products used within 30 days of Screening. Subjects may be users of other tobacco/nicotine-containing products. If the subject is a dual/poly user of tobacco/nicotine-containing products then the subject must self report that a cartridge-based, closed-system ENDS is their primary product.
- Must have used 2 or more ENDS cartridges per week over the last 30 days. 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).
- 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 three-week ambulatory period. Use of other non-ENDS tobacco/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 an electronic device, that allows for both Bluetooth connectivity and internet connectivity and be willing to keep both active for the length of the study.
- Must be willing to use an application on the provided electronic device, and keep the application active for the length of the study.
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 participant unsuitable to participate in this clinical study.
- History 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-Enrollment 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 of informed consent.
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- Participation in another clinical trial within (≤) 30 days prior to signing the ICF. 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.
- Postpones a decision to quit using tobacco/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.
- Determined by the PI to be inappropriate for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, 37920
About this study
This study will be a single-center, controlled, open-label, parallel study 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 an ENDS Investigational Product (IP) product with 4.8% nicotine over a three-week ambulatory period. This study will be conducted in support of a Premarket Tobacco Product Application (PMTA) ENDS submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP).
Read the detailed description
Potential subjects will complete a pre-screening interview and a Screening Visit to assess their eligibility and, based on meeting eligibility requirements, will be enrolled into the study on the same day of the Screening Visit.
Once enrolled, the subjects will be assigned to one of the seven flavor variants of ENDS product. Subjects will be allowed to sample flavors and determine which flavor that they would like to use for the length of the study. Subjects will then participate in a three-week ambulatory study in which they will use their assigned IP in place of their UB ENDS. Subjects will be directed to not use their UB ENDS products during the study.
At the initial visit, subjects will be provided an orientation to the product, including the IP power unit, cartridges, the Product Use and Behavior (PUB) instrument, PUB application, and a provided electronic device. Based upon their UB ENDS usage, they will be given a sufficient amount (for three weeks of ad libitum use equaling 375% of their self-reported UB weekly use) of ENDS cartridges. The study will involve a one-week acclimation period followed by a two-week product use evaluation period. At the end of the first week of the study, subjects will receive a phone call from the clinic to assess IP compliance and to ensure that they are not using their UB ENDS. The PUB instrument will collect topography data, and product use data will be uploaded frequently using a web-based PUB application installed on the electronic device provided by the Sponsor. Throughout the study, subjects will receive weekly phone calls to remind them of guidelines for using their assigned IP. Subjects will be instructed to use the IP in place of their UB ENDS, but they will be allowed to use non-ENDS tobacco/nicotine-containing products according to their normal use pattern. All used cartridges may be disposed of by the subject.
At the conclusion of the three-week ambulatory period, subjects will return to the clinic; return the IP power unit, charger, all unused cartridges, the PUB instrument (and all cables/charger), and the provided electronic device. Each subject will complete all End of Study procedures, including completing the Product Evaluation Scale (PES) questionnaire, and they will then be discharged from the study.
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Being tested
- CSD1905-11, CSD1905-12, CSD1905-13, CSD1905-14, CSD1905-15
- 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.
CSD1905-11Other
Flavor variant CSD1905-11 of a 4.8% nicotine ENDS product
CSD1905-12Other
Flavor variant CSD1905-12 of a 4.8% nicotine ENDS product
CSD1905-13Other
Flavor variant CSD1905-13 of a 4.8% nicotine ENDS product
CSD1905-14Other
Flavor variant CSD1905-14 of a 4.8% nicotine ENDS product
CSD1905-15Other
Flavor variant CSD1905-15 of a 4.8% nicotine ENDS product
CSD1905-16Other
Flavor variant CSD1905-16 of a 4.8% nicotine ENDS product
CSD1905-17Other
Flavor variant CSD1905-17 of a 4.8% nicotine ENDS product
| Study group | Role | What they receive |
|---|---|---|
| CSD1905-11 | Experimental | Subjects will be assigned to flavor variant CSD1905-11 of 4.8% ENDS products based on their preferred flavor. Receives: Other: CSD1905-11 |
| CSD1905-12 | Experimental | Subjects will be assigned to flavor variant CSD1905-12 of 4.8% ENDS products based on their preferred flavor. Receives: Other: CSD1905-12 |
| CSD1905-13 | Experimental | Subjects will be assigned to flavor variant CSD1905-13 of 4.8% ENDS products based on their preferred flavor. Receives: Other: CSD1905-13 |
| CSD1905-14 | Experimental | Subjects will be assigned to flavor variant CSD1905-14 of 4.8% ENDS products based on their preferred flavor. Receives: Other: CSD1905-14 |
| CSD1905-15 | Experimental | Subjects will be assigned to flavor variant CSD1905-15 of 4.8% ENDS products based on their preferred flavor. Receives: Other: CSD1905-15 |
| CSD1905-16 | Experimental | Subjects will be assigned to flavor variant CSD1905-16 of 4.8% ENDS products based on their preferred flavor. Receives: Other: CSD1905-16 |
| CSD1905-17 | Experimental | Subjects will be assigned to flavor variant CSD1905-17 of 4.8% ENDS products based on their preferred flavor. Receives: Other: CSD1905-17 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arithmetic Mean
Arithmetic Mean puff duration
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 posted13 Jan 2020
- Study start14 Jan 2020
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 75 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
- NCT04226404
- Sponsor's protocol ID
- CSD190501
- Status last verified
- Sep 2020
- First submitted
- 9 Jan 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Underly R, Dull GM, Nudi E, Pionk T, Prevette K, Smith J. Using a Novel Connected Device for the Collection of Puffing Topography Data for the Vuse Solo Electronic Nicotine Delivery System in a Real-World Setting: Prospective Ambulatory Clinical Study. JMIR Form Res. 2023 Oct 30;7:e49876. doi: 10.2196/49876.
PubMed 37902830
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD190501: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting
- ClinicalTrials.gov ID
- NCT04226404
- Acronym / sponsor ID
- CSD190501
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 13 Jan 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 be a single-center, controlled, open-label, parallel study 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 an ENDS Investigational Product (IP) product with 4.8% nicotine over a three-week ambulatory period. This study will be conducted in support of a Premarket Tobacco Product Application (PMTA) ENDS submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP).
Detailed description
Potential subjects will complete a pre-screening interview and a Screening Visit to assess their eligibility and, based on meeting eligibility requirements, will be enrolled into the study on the same day of the Screening Visit.
Once enrolled, the subjects will be assigned to one of the seven flavor variants of ENDS product. Subjects will be allowed to sample flavors and determine which flavor that they would like to use for the length of the study. Subjects will then participate in a three-week ambulatory study in which they will use their assigned IP in place of their UB ENDS. Subjects will be directed to not use their UB ENDS products during the study.
At the initial visit, subjects will be provided an orientation to the product, including the IP power unit, cartridges, the Product Use and Behavior (PUB) instrument, PUB application, and a provided electronic device. Based upon their UB ENDS usage, they will be given a sufficient amount (for three weeks of ad libitum use equaling 375% of their self-reported UB weekly use) of ENDS cartridges. The study will involve a one-week acclimation period followed by a two-week product use evaluation period. At the end of the first week of the study, subjects will receive a phone call from the clinic to assess IP compliance and to ensure that they are not using their UB ENDS. The PUB instrument will collect topography data, and product use data will be uploaded frequently using a web-based PUB application installed on the electronic device provided by the Sponsor. Throughout the study, subjects will receive weekly phone calls to remind them of guidelines for using their assigned IP. Subjects will be instructed to use the IP in place of their UB ENDS, but they will be allowed to use non-ENDS tobacco/nicotine-containing products according to their normal use pattern. All used cartridges may be disposed of by the subject.
At the conclusion of the three-week ambulatory period, subjects will return to the clinic; return the IP power unit, charger, all unused cartridges, the PUB instrument (and all cables/charger), and the provided electronic device. Each subject will complete all End of Study procedures, including completing the Product Evaluation Scale (PES) questionnaire, and they 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
- 7
| Arm | Type | Receives |
|---|---|---|
| CSD1905-11 | Experimental | Other: CSD1905-11Subjects will be assigned to flavor variant CSD1905-11 of 4.8% ENDS products based on their preferred flavor. |
| CSD1905-12 | Experimental | Other: CSD1905-12Subjects will be assigned to flavor variant CSD1905-12 of 4.8% ENDS products based on their preferred flavor. |
| CSD1905-13 | Experimental | Other: CSD1905-13Subjects will be assigned to flavor variant CSD1905-13 of 4.8% ENDS products based on their preferred flavor. |
| CSD1905-14 | Experimental | Other: CSD1905-14Subjects will be assigned to flavor variant CSD1905-14 of 4.8% ENDS products based on their preferred flavor. |
| CSD1905-15 | Experimental | Other: CSD1905-15Subjects will be assigned to flavor variant CSD1905-15 of 4.8% ENDS products based on their preferred flavor. |
| CSD1905-16 | Experimental | Other: CSD1905-16Subjects will be assigned to flavor variant CSD1905-16 of 4.8% ENDS products based on their preferred flavor. |
| CSD1905-17 | Experimental | Other: CSD1905-17Subjects will be assigned to flavor variant CSD1905-17 of 4.8% 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, ≥21 years of age, inclusive, at the time of consent.
- Positive urine cotinine test at Screening.
- Cartridge-based, closed-system ENDS are the primary form of tobacco/nicotine-containing products used within 30 days of Screening. Subjects may be users of other tobacco/nicotine-containing products. If the subject is a dual/poly user of tobacco/nicotine-containing products then the subject must self report that a cartridge-based, closed-system ENDS is their primary product.
- Must have used 2 or more ENDS cartridges per week over the last 30 days. 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).
Key exclusion criteria (13 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 participant unsuitable to participate in this clinical study.
- History 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-Enrollment 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 |
|---|---|---|
| CSD1905-11Flavor variant CSD1905-11 of a 4.8% nicotine ENDS product | Other | CSD1905-11 |
| CSD1905-12Flavor variant CSD1905-12 of a 4.8% nicotine ENDS product | Other | CSD1905-12 |
| CSD1905-13Flavor variant CSD1905-13 of a 4.8% nicotine ENDS product | Other | CSD1905-13 |
| CSD1905-14Flavor variant CSD1905-14 of a 4.8% nicotine ENDS product | Other | CSD1905-14 |
| CSD1905-15Flavor variant CSD1905-15 of a 4.8% nicotine ENDS product | Other | CSD1905-15 |
| CSD1905-16Flavor variant CSD1905-16 of a 4.8% nicotine ENDS product | Other | CSD1905-16 |
| CSD1905-17Flavor variant CSD1905-17 of a 4.8% nicotine ENDS product | Other | CSD1905-17 |
Primary outcome
Arithmetic Mean
Time frame: 2 weeks
Arithmetic Mean puff duration
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 25 Sep 2020.
- Derived from this study: PubMed 37902830Underly R, Dull GM, Nudi E, Pionk T, Prevette K, Smith J. Using a Novel Connected Device for the Collection of Puffing Topography Data for the Vuse Solo Electronic Nicotine Delivery System in a Real-World Setting: Prospective Ambulatory Clinical Study. JMIR Form Res. 2023 Oct 30;7:e49876. doi: 10.2196/49876.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSD1905-11, CSD1905-12 and CSD1905-13 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 9 inclusion and 13 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 25 Sep 2020. 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?
Arithmetic Mean (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 NCT04226404, which also lists 1 linked publication.
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 25 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.