SmokingNCT05184920
CSD201004: An Actual Use Study of P10 and P13 Nicotine Pouches Among U.S. Adult Smokers
An observational study of Smoking and Tobacco Use, run by RAI Services Company at 10 sites in United States.
Trial summary
The purpose of this Actual Use Study (AUS) is to investigate how U.S. adult tobacco consumers 21-60 years of age) who are regular smokers (≥5 cigarettes/day) on at least 20 days out of the past 30 days will use P10 and P13 nicotine pouches (Study Investigational Product [IP]) over a 6-week Actual Use Period (AUP) in… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco Use, Tobacco Smoking
- What is being tested?
- P1012919 nicotine pouch, P1012915 nicotine pouch and P1012914 nicotine pouch
- How many people
- 1,105 participants
- Where
- 10 sitesUnited States
- Study dates
- 19 Jan 2022to 29 Apr 2022
- Phase
- Observational
- 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
Study population: The study sample will comprise approximately 1,200 generally healthy, U.S. adult tobacco consumer 21 to 60 years of age, inclusive, who are regular smokers (≥5 cigarettes/day) on at least 20 of the past 30 days, who are not currently quitting all TNP use, and who have no intention of quitting all TNP use in the next three months (intention of quitting CC use only is allowable). A recruiting target for younger smokers (21-30 years old) of approximately 15% will be established 15% to ensure that they are sufficiently represented among the enrolled subjects.
Who may be able to join
- Adult males or females, 21-60 years old, inclusive, verified with government-issued photo ID.
- Must be a current smoker of factory-made filtered menthol and/or non-menthol cigarettes, has smoked at least 100 cigarettes in their lifetime, and typically smokes on at least 20 days out of the past 30 days.
- Smokes on average ≥ 5 combustible cigarettes per day (CPD) on days when cigarettes are smoked. (There are no other requirements or exclusions regarding other TNP use. Dual and poly-users may enroll if they fulfill the cigarette use requirements.)
- Must indicate "an intention to use" Study IP after a brief review of product information and product demonstration at the SEV. Subjects will not try the product at the SEV.
- Available and interested in participating in an 8-week study about the Study IP.
- Able and willing to comply with all study requirements, including questionnaires, the eDiary reporting procedures, and provide valid contact information.
Show all 10Show fewer
- Able to read, understand, and willing to sign Informed Consent Forms (ICFs) and complete questionnaires written in English.
- Has not participated in any tobacco-, vapor-, or nicotine-related research within 3 months of screening.
- Agrees that the IP received are for their own personal use and they will not share the product with others.
- Agrees to restrict use of Study IP to only the investigational products (specified flavors, nicotine levels, and pouch sizes) supplied by the study Sponsor free of charge and labeled as "For Investigational Use Only" and to not obtain/use any other nicotine pouch products from other commercial sources.
Who cannot join
- Self-reports as currently quitting or intending to quit within the next 3 months all tobacco or nicotine product use ("currently" is defined as within (≤) 30 days). Those who intend to quit CC only can be enrolled.
- Must not be an ever-user of any nicotine pouches prior to screening.
- Female subjects who are currently pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
- Female subjects who self-report they are not using adequate methods to prevent pregnancy.
- Self-reports "poor" physical health (based on the five-category Population Assessment of Tobacco and Health (PATH) questionnaire): "In general, how would you rate your physical health?" (Response choices: Excellent, Very Good, Good, Fair, Poor).
- Self-reports "poor" mental health (based on the five-category PATH questionnaire): "In general, how would you rate your mental health?" (Response choices: Excellent, Very Good, Good, Fair, Poor).
- Employees of tobacco or vapor companies.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Schlesinger Atlanta
Atlanta, Georgia, 30328
Schlesinger Chicago
Chicago, Illinois, 60611
Schlesinger Columbus
Columbus, Ohio, 43235
Schlesinger Dallas
Dallas, Texas, 75254
Schlesinger Houston
Houston, Texas, 77027
Schlesinger New Jersey
Iselin, New Jersey, 08830
Schlesinger Kansas City
Kansas City, Missouri, 64114
Schlesinger Philadelphia
Philadelphia, Pennsylvania, 19103
Schlesinger Phoenix
Phoenix, Arizona, 85016
Schlesinger St. Louis
St Louis, Missouri, 63131
About this study
The purpose of this Actual Use Study (AUS) is to investigate how U.S. adult tobacco consumers 21-60 years of age) who are regular smokers (≥5 cigarettes/day) on at least 20 days out of the past 30 days will use P10 and P13 nicotine pouches (Study Investigational Product [IP]) over a 6-week Actual Use Period (AUP) in their real-life/naturalistic environment and in the context of typical consumer marketing materials. Subjects will self-report their ad libitum use of the Study IP as well as use of combustible cigarette (CC) and any other tobacco- or nicotine-containing product (TNP) on a daily basis using an electronic diary (eDiary). The study design is planned to address topics that FDA's Center for Tobacco Products (CTP) has identified as useful in evaluating new tobacco products.
Read the detailed description
The AUS is a multi-site, open-label, 8-week, prospective observational study, conducted at multiple sites geographically dispersed within the U.S.
Adult smokers will be recruited, and candidate subjects who meet study inclusion criteria and none of the exclusion criteria will give verbal consent for further screening. Candidate subjects will be scheduled to attend an in-person Site Enrollment Visit (SEV).
At the SEV, site staff will confirm eligibility, including age verification with a government-issued photo identification. Candidate subjects will review product information and will be shown physical examples of the Study IP, but will not sample the products. Those who indicate an "intention to use" the Study IP will undergo a second consent process, will be enrolled in the study, and will install and be trained on an eDiary application on their personal smartphones or site provisioned devices.
During a 1-week Baseline Assessment Period (BAP, Week 0), enrolled subjects will record all CC and any other TNP use in the eDiary. At the end of the BAP, subjects will return to the study site for Site Visit 1 (SV1). At this visit, subjects will be able to select up to five different Study IPs for the first two weeks of the AUP from the Study IPs available.
During the subsequent 6-week observational AUP, subjects can choose to use the Study IP (or not). Subjects will be instructed to record all daily Study IP, TNP and CC use in the eDiary. They will return to the site every two weeks during the AUP for an in-person interview to answer questionnaires and for product accountability and resupply. As with SV1, at Site Visit 2 (SV2) and Site Visit 3 (SV3), subjects will be able to select up to five IP varieties (if desired) for use during the subsequent 2-week AUP. After Week 6 of the AUP, there will be a final site visit (SV4) and week-long Close Out Period (COP).
In addition to collecting information on daily ad libitum use of Study IP, TNP and CC use, the study will assess subjective measures (i.e., product assessment) for each Study IP, including product use behaviors and intent to use again (at close of study). Information on intention to quit CC will be collected at enrollment and at study conclusion. A passive surveillance mechanism will be used to collect information on adverse health experiences.
- Conditions
- Smoking, Tobacco Use, Tobacco Smoking
- Being tested
- P1012919 nicotine pouch, P1012915 nicotine pouch, P1012914 nicotine pouch, P1013315 nicotine pouch, P1013119 nicotine pouch
- 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.
P1012919 nicotine pouchOther
P1012919, a nicotine pouch with 12 mg of nicotine
P1012915 nicotine pouchOther
P1012915, a nicotine pouch with 8 mg of nicotine
P1012914 nicotine pouchOther
P1012914, a nicotine pouch with 4 mg of nicotine
P1013315 nicotine pouchOther
P1013315, a nicotine pouch with 8 mg of nicotine
P1013119 nicotine pouchOther
P1013119, a nicotine pouch with 12 mg of nicotine
P1013218 nicotine pouchOther
P1013218, a nicotine pouch with 10 mg of nicotine
P1012818 nicotine pouchOther
P1012818, a nicotine pouch with 10 mg of nicotine
P1312915 nicotine pouchOther
P1312915, a nicotine pouch with 8 mg of nicotine
P1312914 nicotine pouchOther
P1312914, a nicotine pouch with 4 mg of nicotine
P1313015 nicotine pouchOther
P1313015, a nicotine pouch with 8 mg of nicotine
P1313314 nicotine pouchOther
P1313314, a nicotine pouch with 4 mg of nicotine
P1312815 nicotine pouchOther
P1312815, a nicotine pouch with 8 mg of nicotine
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Proportion of Established Users
Number and proportion of subjects who meet the definition of "established users" of the Study IP
Measured: 6 weeks
Number and Proportion of Established Users who reduce their CPD consumption
Number and proportion of subjects among "established users" who reduce their CPD consumption by at least 50%
Measured: 8 weeks
Descriptive weekly average CPD consumption
Descriptive weekly average CPD consumption per subject among all subjects who complete the study, including both established and non-established users of the Study IP
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start19 Jan 2022
- Primary completion29 Apr 2022
- Study completion29 Apr 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,105 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrudu Makena, PhD, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184920
- Sponsor's protocol ID
- CSD201004
- Status last verified
- Jun 2022
- First submitted
- 22 Dec 2021
- 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
- CSD201004: An Actual Use Study of P10 and P13 Nicotine Pouches Among U.S. Adult Smokers
- ClinicalTrials.gov ID
- NCT05184920
- Acronym / sponsor ID
- CSD201004
- Conditions
- Smoking, Tobacco Use, Tobacco Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,105 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 11 Jan 2022 (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.
The purpose of this Actual Use Study (AUS) is to investigate how U.S. adult tobacco consumers 21-60 years of age) who are regular smokers (≥5 cigarettes/day) on at least 20 days out of the past 30 days will use P10 and P13 nicotine pouches (Study Investigational Product [IP]) over a 6-week Actual Use Period (AUP) in their real-life/naturalistic environment and in the context of typical consumer marketing materials. Subjects will self-report their ad libitum use of the Study IP as well as use of combustible cigarette (CC) and any other tobacco- or nicotine-containing product (TNP) on a daily basis using an electronic diary (eDiary). The study design is planned to address topics that FDA's Center for Tobacco Products (CTP) has identified as useful in evaluating new tobacco products.
Detailed description
The AUS is a multi-site, open-label, 8-week, prospective observational study, conducted at multiple sites geographically dispersed within the U.S.
Adult smokers will be recruited, and candidate subjects who meet study inclusion criteria and none of the exclusion criteria will give verbal consent for further screening. Candidate subjects will be scheduled to attend an in-person Site Enrollment Visit (SEV).
At the SEV, site staff will confirm eligibility, including age verification with a government-issued photo identification. Candidate subjects will review product information and will be shown physical examples of the Study IP, but will not sample the products. Those who indicate an "intention to use" the Study IP will undergo a second consent process, will be enrolled in the study, and will install and be trained on an eDiary application on their personal smartphones or site provisioned devices.
During a 1-week Baseline Assessment Period (BAP, Week 0), enrolled subjects will record all CC and any other TNP use in the eDiary. At the end of the BAP, subjects will return to the study site for Site Visit 1 (SV1). At this visit, subjects will be able to select up to five different Study IPs for the first two weeks of the AUP from the Study IPs available.
During the subsequent 6-week observational AUP, subjects can choose to use the Study IP (or not). Subjects will be instructed to record all daily Study IP, TNP and CC use in the eDiary. They will return to the site every two weeks during the AUP for an in-person interview to answer questionnaires and for product accountability and resupply. As with SV1, at Site Visit 2 (SV2) and Site Visit 3 (SV3), subjects will be able to select up to five IP varieties (if desired) for use during the subsequent 2-week AUP. After Week 6 of the AUP, there will be a final site visit (SV4) and week-long Close Out Period (COP).
In addition to collecting information on daily ad libitum use of Study IP, TNP and CC use, the study will assess subjective measures (i.e., product assessment) for each Study IP, including product use behaviors and intent to use again (at close of study). Information on intention to quit CC will be collected at enrollment and at study conclusion. A passive surveillance mechanism will be used to collect information on adverse health experiences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study sample will comprise approximately 1,200 generally healthy, U.S. adult tobacco consumer 21 to 60 years of age, inclusive, who are regular smokers (≥5 cigarettes/day) on at least 20 of the past 30 days, who are not currently quitting all TNP use, and who have no intention of quitting all TNP use in the next three months (intention of quitting CC use only is allowable). A recruiting target for younger smokers (21-30 years old) of approximately 15% will be established 15% to ensure that they are sufficiently represented among the enrolled subjects.
Key inclusion criteria (10 listed)
- Adult males or females, 21-60 years old, inclusive, verified with government-issued photo ID.
- Must be a current smoker of factory-made filtered menthol and/or non-menthol cigarettes, has smoked at least 100 cigarettes in their lifetime, and typically smokes on at least 20 days out of the past 30 days.
- Smokes on average ≥ 5 combustible cigarettes per day (CPD) on days when cigarettes are smoked. (There are no other requirements or exclusions regarding other TNP use. Dual and poly-users may enroll if they fulfill the cigarette use requirements.)
- Must indicate "an intention to use" Study IP after a brief review of product information and product demonstration at the SEV. Subjects will not try the product at the SEV.
- Available and interested in participating in an 8-week study about the Study IP.
Key exclusion criteria (7 listed)
- Self-reports as currently quitting or intending to quit within the next 3 months all tobacco or nicotine product use ("currently" is defined as within (≤) 30 days). Those who intend to quit CC only can be enrolled.
- Must not be an ever-user of any nicotine pouches prior to screening.
- Female subjects who are currently pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
- Female subjects who self-report they are not using adequate methods to prevent pregnancy.
- Self-reports "poor" physical health (based on the five-category Population Assessment of Tobacco and Health (PATH) questionnaire): "In general, how would you rate your physical health?" (Response choices: Excellent, Very Good, Good, Fair, Poor).
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 |
|---|---|---|
| P1012919 nicotine pouchP1012919, a nicotine pouch with 12 mg of nicotine | Other | – |
| P1012915 nicotine pouchP1012915, a nicotine pouch with 8 mg of nicotine | Other | – |
| P1012914 nicotine pouchP1012914, a nicotine pouch with 4 mg of nicotine | Other | – |
| P1013315 nicotine pouchP1013315, a nicotine pouch with 8 mg of nicotine | Other | – |
| P1013119 nicotine pouchP1013119, a nicotine pouch with 12 mg of nicotine | Other | – |
| P1013218 nicotine pouchP1013218, a nicotine pouch with 10 mg of nicotine | Other | – |
| P1012818 nicotine pouchP1012818, a nicotine pouch with 10 mg of nicotine | Other | – |
| P1312915 nicotine pouchP1312915, a nicotine pouch with 8 mg of nicotine | Other | – |
| P1312914 nicotine pouchP1312914, a nicotine pouch with 4 mg of nicotine | Other | – |
| P1313015 nicotine pouchP1313015, a nicotine pouch with 8 mg of nicotine | Other | – |
| P1313314 nicotine pouchP1313314, a nicotine pouch with 4 mg of nicotine | Other | – |
| P1312815 nicotine pouchP1312815, a nicotine pouch with 8 mg of nicotine | Other | – |
Primary outcome
Number and Proportion of Established Users
Time frame: 6 weeks
Number and proportion of subjects who meet the definition of "established users" of the Study IP
Number and Proportion of Established Users who reduce their CPD consumption
Time frame: 8 weeks
Number and proportion of subjects among "established users" who reduce their CPD consumption by at least 50%
Descriptive weekly average CPD consumption
Time frame: 8 weeks
Descriptive weekly average CPD consumption per subject among all subjects who complete the study, including both established and non-established users of the Study IP
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.
Patrudu Makena, PhD study director
RAIS
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Tobacco Use, run by RAI Services Company at 10 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 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Number and Proportion of Established Users (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.