SmokingNCT05307822
CSD210903: A Study to Determine Subject Puffing Patterns of a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in an Ambulatory Setting
A study testing Non-combusted cigarette variant 42001401, Non-combusted cigarette variant 42001399 and Non-combusted cigarette variant 40007386 in people with Smoking and Smoking Behaviors, run by RAI Services Company at 7 sites in United States.
Trial summary
This is a multi-center, open-label, parallel-cohort-study to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) combustible cigarette (CC) and/or a UB Heated Tobacco Product (HTP) to one of four investigational products (IPs), across two heating modes, 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?
- Non-combusted cigarette variant 42001401, Non-combusted cigarette variant 42001399 and Non-combusted cigarette variant 40007386
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 7 sitesUnited States
- Study dates
- 21 Apr 2022to 11 Nov 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.
- CC or HTP is 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 CC or HTP is their primary product.
- Must have used 5 or more CCs or HTP sticks per day 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). Dual users of CCs and HTPs (either 5 CCs or 5 sticks per day or a combination of 5 products per day) will also be allowed into the study.
- Males must use an acceptable method of birth control from Visit 1 until the end of the study, unless they have had a vasectomy or are abstinent from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation), or their female partner is not able to bear children.
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- Females must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until the end of the study.
- Examples of acceptable means of birth control are, but not limited to:
- Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy);
- Established use of oral, implantable, injectable or transdermal methods of contraception associated with inhibition of ovulation;
- Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide;
- Non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena);
- Vasectomized partner;
- Abstinence from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation); and
- Post-menopausal and not on hormone replacement therapy.
- Must be willing to use the assigned IP and only the assigned flavor as their primary source of nicotine use for the full duration of the 28-day ambulatory period. Use of other non-CC or non-HTP tobacco/nicotine-containing products (e.g., ENDS products (e-cigarettes), snuff, snus, chewing tobacco, modern oral pouches) 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, or 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 of, presence of, or clinical laboratory test results indicating diabetes.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes.
- 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 allowed at the PI's discretion, pending written approval from the Medical Monitor.
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that have been surgically and/or cryogenically removed.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
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- Use of any medication or substance that aids in smoking cessation, including but not limited to: NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to signing the ICF.
- 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, or who are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- Subjects ≥ 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 Visit or Enrollment Visit.
- 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 alcohol test result at the Screening Visit or Enrollment Visit.
- 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
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Rose Research Center
Charlotte, North Carolina, 28262
Benchmark Research
Fort Worth, Texas, 76135
High Point Clinical Trials Center
High Point, North Carolina, 27265
AMR Lexington
Lexington, Kentucky, 40509
Rose Research Center
Raleigh, North Carolina, 27617
Benchmark Research
San Angelo, Texas, 76904
Wake Research (MTVCR)
Sandy Springs, Georgia, 30328
About this study
This is a multi-center, open-label, parallel-cohort-study to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) combustible cigarette (CC) and/or a UB Heated Tobacco Product (HTP) to one of four investigational products (IPs), across two heating modes, over a 28-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 within 28 days prior to enrollment. Based on meeting eligibility requirements, subjects will be scheduled to return to the clinic to complete Enrollment.
This study will recruit adult smokers of both non-menthol and menthol combustible cigarettes, users of non-menthol and menthol HTPs, and dual users of non-menthol and menthol CCs and HTPs.
To minimize bias, subjects will be assigned to either a non-menthol or menthol HTP IP flavor cohort depending upon self-reported flavor usage history. Subjects who report using non-menthol CC/HTP will be assigned to the single non-menthol HTP IP group, and subjects who report using menthol CC/HTP will be assigned to one of the three menthol HTP IP groups after optionally sampling the three menthol HTP IPs and determining which menthol product they would like to use for the length of the study. Once a particular menthol flavor group has reached full enrollment, that flavor will no longer be available for sampling and selection. Subjects will be instructed not to use UB CC or HTP during the study.
At the Enrollment Visit, subjects will be provided a heating device, HTP IPs for their assigned product, a Product Use and Behavior (PUB) instrument, and an electronic device for use with the PUB instrument. The electronic device will have the PUB application installed for topography data capture and PUB data transmission. Subjects will be trained on using the heating device, connecting the PUB instrument, and using the electronic device for PUB data transmission. Based upon their self-reported UB CC and/or HTP usage, subjects will be given a sufficient amount of the assigned HTP IP.
Subjects will be instructed to use the assigned HTP IP in place of UB CC and HTP, as applicable per the subject's normal product use pattern, during the 28-day study period (including a 14-day IP acclimation period followed by a 14-day product use evaluation period). Subjects will be allowed to use non-CC or non-HTP tobacco/nicotine-containing products (e.g., ENDS products (e-cigarettes), snuff, snus, chewing tobacco, modern oral pouches) according to the subject's normal use pattern. The PUB instrument will collect puffing topography data throughout the product use periods.
At the end of the 14-day acclimation period of the study, subjects will receive a phone call from the clinic to assess IP compliance and to ensure that they are not using UB CC or UB HTP and to document any AEs. During the following evaluation period (Days 15-28), subjects will receive a phone call to remind them of guidelines for using their assigned IP and to document any AEs.
At the conclusion of the 28-day ambulatory period, the subjects will return to the clinic, return the heating device, HTP Accessory USB charger and accessories, all unused HTP IPs, the corresponding PUB instrument and its charger, and the electronic device and its charger. Each subject will complete all End of Study procedures including completing the Product Evaluation Scale (PES) questionnaire, two additional questionnaires to assess overall product liking and intention to use, and then subjects will be discharged from the study.
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Being tested
- Non-combusted cigarette variant 42001401, Non-combusted cigarette variant 42001399, Non-combusted cigarette variant 40007386, Non-combusted cigarette variant 42001402
- 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.
Non-combusted cigarette variant 42001401Other
Menthol flavor variant of a non-combusted cigarette (42001401)
Non-combusted cigarette variant 42001399Other
Menthol flavor variant of a non-combusted cigarette (42001399)
Non-combusted cigarette variant 40007386Other
Menthol flavor variant of a non-combusted cigarette (40007386)
Non-combusted cigarette variant 42001402Other
Non-Menthol flavor variant of a non-combusted cigarette (42001402)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Menthol with HTP device (20020064) | Experimental | Subjects will self-assign to one of three menthol flavor variants of non-combusted cigarette products based on their self-reported flavor usage history. Receives: Other: Non-combusted cigarette variant 42001401; Other: Non-combusted cigarette variant 42001399; Other: Non-combusted cigarette variant 40007386 |
| Cohort 2: Non-Menthol with HTP device (20020064) | Experimental | Subjects will self-assign to a non-menthol flavor variant of a non-combusted cigarette product based on their self-reported flavor usage history. Receives: Other: Non-combusted cigarette variant 42001402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arithmetic Mean
Arithmetic Mean puff duration across the final 14 days of data collection
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start21 Apr 2022
- Primary completion11 Nov 2022
- Study completion11 Nov 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
- 194 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
- NCT05307822
- Sponsor's protocol ID
- CSD210903
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2022
- Last updated
- 27 Mar 2023
- 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 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD210903: A Study to Determine Subject Puffing Patterns of a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in an Ambulatory Setting
- ClinicalTrials.gov ID
- NCT05307822
- Acronym / sponsor ID
- CSD210903
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 1 Apr 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.
This is a multi-center, open-label, parallel-cohort-study to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) combustible cigarette (CC) and/or a UB Heated Tobacco Product (HTP) to one of four investigational products (IPs), across two heating modes, over a 28-day ambulatory period.
Detailed description
Potential subjects may complete a pre-screening interview and will complete a Screening Visit to assess their eligibility within 28 days prior to enrollment. Based on meeting eligibility requirements, subjects will be scheduled to return to the clinic to complete Enrollment.
This study will recruit adult smokers of both non-menthol and menthol combustible cigarettes, users of non-menthol and menthol HTPs, and dual users of non-menthol and menthol CCs and HTPs.
To minimize bias, subjects will be assigned to either a non-menthol or menthol HTP IP flavor cohort depending upon self-reported flavor usage history. Subjects who report using non-menthol CC/HTP will be assigned to the single non-menthol HTP IP group, and subjects who report using menthol CC/HTP will be assigned to one of the three menthol HTP IP groups after optionally sampling the three menthol HTP IPs and determining which menthol product they would like to use for the length of the study. Once a particular menthol flavor group has reached full enrollment, that flavor will no longer be available for sampling and selection. Subjects will be instructed not to use UB CC or HTP during the study.
At the Enrollment Visit, subjects will be provided a heating device, HTP IPs for their assigned product, a Product Use and Behavior (PUB) instrument, and an electronic device for use with the PUB instrument. The electronic device will have the PUB application installed for topography data capture and PUB data transmission. Subjects will be trained on using the heating device, connecting the PUB instrument, and using the electronic device for PUB data transmission. Based upon their self-reported UB CC and/or HTP usage, subjects will be given a sufficient amount of the assigned HTP IP.
Subjects will be instructed to use the assigned HTP IP in place of UB CC and HTP, as applicable per the subject's normal product use pattern, during the 28-day study period (including a 14-day IP acclimation period followed by a 14-day product use evaluation period). Subjects will be allowed to use non-CC or non-HTP tobacco/nicotine-containing products (e.g., ENDS products (e-cigarettes), snuff, snus, chewing tobacco, modern oral pouches) according to the subject's normal use pattern. The PUB instrument will collect puffing topography data throughout the product use periods.
At the end of the 14-day acclimation period of the study, subjects will receive a phone call from the clinic to assess IP compliance and to ensure that they are not using UB CC or UB HTP and to document any AEs. During the following evaluation period (Days 15-28), subjects will receive a phone call to remind them of guidelines for using their assigned IP and to document any AEs.
At the conclusion of the 28-day ambulatory period, the subjects will return to the clinic, return the heating device, HTP Accessory USB charger and accessories, all unused HTP IPs, the corresponding PUB instrument and its charger, and the electronic device and its charger. Each subject will complete all End of Study procedures including completing the Product Evaluation Scale (PES) questionnaire, two additional questionnaires to assess overall product liking and intention to use, and then subjects will be discharged from the study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Menthol with HTP device (20020064) | Experimental | Other: Non-combusted cigarette variant 42001401, Other: Non-combusted cigarette variant 42001399, Other: Non-combusted cigarette variant 40007386Subjects will self-assign to one of three menthol flavor variants of non-combusted cigarette products based on their self-reported flavor usage history. |
| Cohort 2: Non-Menthol with HTP device (20020064) | Experimental | Other: Non-combusted cigarette variant 42001402Subjects will self-assign to a non-menthol flavor variant of a non-combusted cigarette product based on their self-reported flavor usage history. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 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.
- CC or HTP is 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 CC or HTP is their primary product.
- Must have used 5 or more CCs or HTP sticks per day 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). Dual users of CCs and HTPs (either 5 CCs or 5 sticks per day or a combination of 5 products per day) will also be allowed into the study.
Key exclusion criteria (15 listed)
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, or 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 of, presence of, or clinical laboratory test results indicating diabetes.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes.
- 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 allowed at the PI's discretion, pending written approval from the Medical Monitor.
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that have 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 |
|---|---|---|
| Non-combusted cigarette variant 42001401Menthol flavor variant of a non-combusted cigarette (42001401) | Other | Cohort 1: Menthol with HTP device (20020064) |
| Non-combusted cigarette variant 42001399Menthol flavor variant of a non-combusted cigarette (42001399) | Other | Cohort 1: Menthol with HTP device (20020064) |
| Non-combusted cigarette variant 40007386Menthol flavor variant of a non-combusted cigarette (40007386) | Other | Cohort 1: Menthol with HTP device (20020064) |
| Non-combusted cigarette variant 42001402Non-Menthol flavor variant of a non-combusted cigarette (42001402) | Other | Cohort 2: Non-Menthol with HTP device (20020064) |
Primary outcome
Arithmetic Mean
Time frame: 14 days
Arithmetic Mean puff duration across the final 14 days 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 Mar 2023.
- 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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-combusted cigarette variant 42001401, Non-combusted cigarette variant 42001399 and Non-combusted cigarette variant 40007386 in people with Smoking and Smoking Behaviors, run by RAI Services Company at 7 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 18 inclusion and 15 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Arithmetic Mean (time frame: 14 days). 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 Mar 2023.