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| Name | Class |
|---|---|
| IPSOS | INDUSTRY |
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This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices, with two variants of HTP consumables ("sticks"), collectively referred to as the study investigational products (Study IP), among a sample of 240 primary users of combustible cigarettes in the United Kingdom (UK). Participants will be using the products for five days at home. Participants demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires. Participants will be asked to complete daily surveys using a survey link. Surveys will collect data on the number of CC smoked and number of sticks consumed the previous day in addition to any other tobacco or nicotine product used. In addition, at the end of the study, participants will complete a survey regarding overall product liking and purchase intent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTP Device 1 | Experimental |
| |
| HTP Device 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P2515910 | Other | Tobacco Flavor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the puffing topography of primary CC smokers when using either the glo or glo plus device with one of two stick variants during a five-day use period. | The primary endpoints of this study will be measured in using built-in topography measures and the product use behavior (PUB) instrument (Study Arm 1 only). The data will include:
| 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the frequency of use of the glo and glo plus devices in Standard and Boost Mode | This secondary endpoint will be measured using the built-in topography measures through the Product Use Behavior (PUB) device | 5 days |
| Determine the frequency of use of the glo plus pen detached from the charger pack (Study Arm 2 only) |
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Inclusion Criteria:
Exclusion Criteria:
Female participants who self-report they are pregnant or breastfeeding or could become pregnant or start breastfeeding in the next 6 months from the study start date.
Women who self-report they are not intending to use adequate contraception methods to prevent pregnancy.
a) Examples of acceptable contraception methods are, but not limited to: i. Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy); ii. Established use of oral, implantable, injectable, or transdermal methods of contraception associated with inhibition of ovulation; iii. Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide; iv. Non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena); v. Vasectomized partner; vi. Abstinence from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation); and vii. Post-menopausal who are not on hormone replacement therapy.
Males who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or to refrain from donating sperm from the time of signing the informed consent until the EOS, unless they have undergone a vasectomy or were abstinent from heterosexual intercourse, or their female partner was not able to bear children.
Individuals who self-report having pacemakers or other embedded electronic medical devices.
Individuals who self-report having an unstable heart condition, severe hypertension or diabetes.
Individuals who self-report they are sensitive to nicotine.
Individuals who respond with 'Poor' or 'Don't know' to general physical or mental health.
Individuals who have used a nicotine replacement therapy (NRT) product or a prescription drug to help stop smoking (e.g., varenicline, bupropion) in the past 30 days.
Individuals who are employed by a company that manufactures tobacco, HTPs, marketing or in ongoing litigation with a tobacco company.
Individuals who self-report that they are planning to quit all nicotine products in the next three months.
Individuals who are personally, have household members, or have close family or friends in ongoing or past litigation with a company that manufactures tobacco or HTPs.
People who have taken part in a tobacco/nicotine research study in the past 30 days.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Montgomery Hedgecock | Contact | 336-741-3761 | montgomery_hedgecock@rjrt.com |
| Name | Affiliation | Role |
|---|---|---|
| Melissa Tapia, Ph.D. | RAIS Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cheshunt Community Sports Park | Cheshunt | United Kingdom | ||||
| Channing Hall |
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| P2512610 |
| Other |
Menthol Flavor |
|
This secondary endpoint will be measured using the built-in topography measures through the Product Use Behavior (PUB) device |
| 5 days |
| Determine the average daily consumption (ADC) of CC smoked, sticks consumed, and other TNPs used | Through self-reported questionnaires | 5 days |
| Determine overall product liking and purchase intent | Overall Product Liking: 1 (Strongly Dislike) - 10 (Strongly Like) Purchase Intent: 1 (Definitely would not purchase) - 10 (Definitely would purchase) | 5 days |
| Characterize demographic characteristics | 5 days |
| Determine the safety profile (i.e., adverse events/experiences [AEs]) of the Study IP | 5 days |
| Sheffield |
| United Kingdom |