SmokingNCT04104152
CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting
A study testing CSD1902-11, CSD1902-12 and CSD1902-13 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, randomized, controlled, open-label, parallel 2-cohort study to evaluate the puffing patterns of individuals switching from a similar usual brand (UB) Electronic Nicotine Delivery System (ENDS) product to either a 2.4% or 5% nicotine level ENDS product in healthy adult ENDS users. 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?
- CSD1902-11, CSD1902-12 and CSD1902-13
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2019to 6 Mar 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 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.
- Positive urine cotinine test at Screening.
- Non-cylindrical, cartridge-based, closed system, ENDS are the primary form (> 50% of total use over the last month) of tobacco- or nicotine-containing product used within 30 days of Screening.
- Must have purchased and 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 Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the Principal Investigator (PI).
- Primary flavor preference (75% use per week, self-reported) must be either Tobacco, Mint/Menthol, or a Fruit/Berry flavor and listed in the acceptable UB product guide.
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- 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.
- Must be willing to use a the assigned non-cylindrical, cartridge-based product and only the assigned flavor as their exclusive source of ENDS use for the full duration of the 3-week ambulatory period.
- Must have a modern IOS/Android phone (as described in the study procedures manual) 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 install an application onto their personal smartphone 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- 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.
- Determined by the PI to be inappropriate for this 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
This study will be a single-center, randomized, controlled, open-label, parallel 2-cohort study to evaluate the puffing patterns of individuals switching from a similar usual brand (UB) Electronic Nicotine Delivery System (ENDS) product to either a 2.4% or 5% nicotine level ENDS product in healthy adult ENDS users. This study will be conducted for potential submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as part of a Premarket Tobacco Product Application (PMTA) for an Electronic Nicotine Delivery System (ENDS), comprised of an electrical power unit and four flavor variants each with two different levels of nicotine (2.4% and 5.0%).
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 randomized to either the 5.0% nicotine ENDS products or the 2.4% nicotine ENDS products. Once randomized to the nicotine level, subjects will be assigned to one of the four flavor variants based on alignment with their preferred UB flavor.
Subjects will be provided an orientation to the product and the Product Use and Behavior (PUB) instrument and provided with enough cartridges (sufficient for three weeks of product use [125% their reported weekly use of their UB]) to last the 3-week period of the study.
The subjects will take the products home and use them ad libitum for a 1-week acclimation period followed by a 2-week product use period. During this time product use will be captured by the PUB instrument and their data uploaded to the cloud regularly.
At the conclusion of the 3-week ambulatory period, the subject will return to the clinic, return the ENDS power unit, used and unused ENDS cartridges, and the PUB instrument (and all cables/charger), have his/her health status reevaluated, complete the Product Evaluation Scale (PES) questionnaire and will then be discharged from the study.
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Being tested
- CSD1902-11, CSD1902-12, CSD1902-13, CSD1902-14, CSD1902-21
- 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.
CSD1902-11Other
A 2.4% nicotine ENDS product
CSD1902-12Other
A 2.4% nicotine ENDS product
CSD1902-13Other
A 2.4% nicotine ENDS product
CSD1902-14Other
A 2.4% nicotine ENDS product
CSD1902-21Other
A 5.0% nicotine ENDS product
CSD1902-22Other
A 5.0% nicotine ENDS product
CSD1902-23Other
A 5.0% nicotine ENDS product
CSD1902-24Other
A 5.0% nicotine ENDS product
| Study group | Role | What they receive |
|---|---|---|
| ENDS 2.4% nicotine | Experimental | Subjects will be assigned to one of four flavors variants of 2.4% ENDS products based on their preferred UB flavor. Receives: Other: CSD1902-11; Other: CSD1902-12; Other: CSD1902-13; Other: CSD1902-14 |
| ENDS 5.0% nicotine | Experimental | Subjects will be assigned to one of four flavors variants of 5.0% ENDS products based on their preferred UB flavor. Receives: Other: CSD1902-21; Other: CSD1902-22; Other: CSD1902-23; Other: CSD1902-24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arithmetic Mean
Arithmetic Mean puff duration for 5.0% nicotine and 2.4% nicotine ENDS products across the final two weeks of data collection
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 posted26 Sep 2019
- Study start7 Oct 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Smith, PhD, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104152
- Sponsor's protocol ID
- CSD190203
- Status last verified
- Jun 2022
- First submitted
- 24 Sep 2019
- 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
- CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting
- ClinicalTrials.gov ID
- NCT04104152
- Acronym / sponsor ID
- CSD190203
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 26 Sep 2019 (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, randomized, controlled, open-label, parallel 2-cohort study to evaluate the puffing patterns of individuals switching from a similar usual brand (UB) Electronic Nicotine Delivery System (ENDS) product to either a 2.4% or 5% nicotine level ENDS product in healthy adult ENDS users. This study will be conducted for potential submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as part of a Premarket Tobacco Product Application (PMTA) for an Electronic Nicotine Delivery System (ENDS), comprised of an electrical power unit and four flavor variants each with two different levels of nicotine (2.4% and 5.0%).
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 randomized to either the 5.0% nicotine ENDS products or the 2.4% nicotine ENDS products. Once randomized to the nicotine level, subjects will be assigned to one of the four flavor variants based on alignment with their preferred UB flavor.
Subjects will be provided an orientation to the product and the Product Use and Behavior (PUB) instrument and provided with enough cartridges (sufficient for three weeks of product use [125% their reported weekly use of their UB]) to last the 3-week period of the study.
The subjects will take the products home and use them ad libitum for a 1-week acclimation period followed by a 2-week product use period. During this time product use will be captured by the PUB instrument and their data uploaded to the cloud regularly.
At the conclusion of the 3-week ambulatory period, the subject will return to the clinic, return the ENDS power unit, used and unused ENDS cartridges, and the PUB instrument (and all cables/charger), have his/her health status reevaluated, complete the Product Evaluation Scale (PES) questionnaire and will then be discharged from the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENDS 2.4% nicotine | Experimental | Other: CSD1902-11, Other: CSD1902-12, Other: CSD1902-13, Other: CSD1902-14Subjects will be assigned to one of four flavors variants of 2.4% ENDS products based on their preferred UB flavor. |
| ENDS 5.0% nicotine | Experimental | Other: CSD1902-21, Other: CSD1902-22, Other: CSD1902-23, Other: CSD1902-24Subjects will be assigned to one of four flavors variants of 5.0% ENDS products based on their preferred UB flavor. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 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.
- Positive urine cotinine test at Screening.
- Non-cylindrical, cartridge-based, closed system, ENDS are the primary form (> 50% of total use over the last month) of tobacco- or nicotine-containing product used within 30 days of Screening.
- Must have purchased and 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 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 |
|---|---|---|
| CSD1902-11A 2.4% nicotine ENDS product | Other | ENDS 2.4% nicotine |
| CSD1902-12A 2.4% nicotine ENDS product | Other | ENDS 2.4% nicotine |
| CSD1902-13A 2.4% nicotine ENDS product | Other | ENDS 2.4% nicotine |
| CSD1902-14A 2.4% nicotine ENDS product | Other | ENDS 2.4% nicotine |
| CSD1902-21A 5.0% nicotine ENDS product | Other | ENDS 5.0% nicotine |
| CSD1902-22A 5.0% nicotine ENDS product | Other | ENDS 5.0% nicotine |
| CSD1902-23A 5.0% nicotine ENDS product | Other | ENDS 5.0% nicotine |
| CSD1902-24A 5.0% nicotine ENDS product | Other | ENDS 5.0% nicotine |
Primary outcome
Arithmetic Mean
Time frame: 2 weeks
Arithmetic Mean puff duration for 5.0% nicotine and 2.4% nicotine ENDS products across the final two weeks of data collection
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.
Jeff Smith, 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 CSD1902-11, CSD1902-12 and CSD1902-13 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 10 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 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?
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?
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.