A Consumer Use Behavior Study to Evaluate Puffing Topography and Average Daily Consumption of Heated Tobacco Products
NCT ID: NCT07175987
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
212 participants
INTERVENTIONAL
2025-09-01
2025-09-25
Brief Summary
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In addition to puffing topography measurements at the CLT, a tobacco product perceptions and intentions survey will be used to assess study participants' intent to purchase the Study IP, their risk perceptions, and their intended use behaviors. Participants' demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires.
Following completion of the CLT, a subset (n=100) of the originally enrolled population will participate in a 5-day home use testing (HUT) period in which they will use the Study IP for 5 days in their everyday environments to assess average daily consumption (ADC) and usage patterns of the Study IP, as well as use of any other TNPs, recorded in a daily survey. On completion of the last day of the HUT, participants will complete a final end of study survey assessing product liking, purchase intent, and intended use behaviors.
Detailed Description
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In addition to puffing topography measurements at the CLT, a tobacco product perceptions and intentions survey will be used to assess study participants' intent to purchase the Study IP, their risk perceptions, and their intended use behaviors. Participants' demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires.
Following completion of the CLT, a subset (n=100) of the originally enrolled population will participate in a 5-day home use testing (HUT) period in which they will use the Study IP for 5 days in their everyday environments to assess average daily consumption (ADC) and usage patterns of the Study IP, as well as use of any other TNPs, recorded in a daily survey. On completion of the last day of the HUT, participants will complete a final end of study survey assessing product liking, purchase intent, and intended use behaviors.
To account for respondent drop-out, the fieldwork team will recruit approximately 15% more participants for the CLT and approximately 20% more participants to the HUT phase.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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HTP Device (1)
Participants will be randomized to one of three stick variants.
RDTH002581
Participants assigned to this Study Intervention will use the product only in the CLT portion of the study.
RDTH002580
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
RDTH002582
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
HTP Device (2)
Participants will be randomized to one of three stick variants.
RDTH002578
Participants assigned to this Study Intervention will use the product only in the CLT portion of the study.
RDTH002577
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
RDTH002579
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
Interventions
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RDTH002581
Participants assigned to this Study Intervention will use the product only in the CLT portion of the study.
RDTH002580
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
RDTH002582
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
RDTH002578
Participants assigned to this Study Intervention will use the product only in the CLT portion of the study.
RDTH002577
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
RDTH002579
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
Eligibility Criteria
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Inclusion Criteria
* Be self-reported current 'daily users' of at least 5 CPD and have smoked at least 100 cigarettes in their lifetime. ('daily users' defined as have smoked 5 CPD for at least 27 days out of last 30 days)
* Agree to participate in the study and to abide by the study restrictions and requirements, including the use of the assigned Study IP, as described in the ICF.
* Agree not to allow any other person to use any product provided to them for use during this study.
Exclusion Criteria
* Women who self-report they are not using adequate methods to prevent pregnancy, which they intend to continue throughout the study.
a. Examples of acceptable means of birth control are, but not limited to: i. Surgical sterilization (hysterectomy, bilateral tubal litigation/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 and not on hormone replacement Therapy
* People who self- report having pacemakers or other embedded electronic medical devices.
* People who self-report having heart disease, high blood pressure, diabetes, depression, or asthma.
* People who have ever used HTP.
* People who self-report currently quitting or planning to quit all nicotine products in the next 3 months.
* People who self-report having participated in tobacco product research in the past 3 months.
* People who self-report themselves, or someone in their direct family or close friends, as working in one of the following areas:
1. Advertising
2. Journalism
3. Media
4. Insurance
5. Marketing
6. Market Research
7. Manufacturer or retailer of tobacco or vapor products
8. Public Relations
9. Sale of Alcohol
21 Years
65 Years
ALL
Yes
Sponsors
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IPSOS
INDUSTRY
RAI Services Company
INDUSTRY
Responsible Party
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Principal Investigators
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Melissa Tapia, Ph.D.
Role: STUDY_DIRECTOR
RAI Services Company
Locations
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Channing Hall
Sheffield, , United Kingdom
Countries
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Other Identifiers
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PHCB2IT20257
Identifier Type: -
Identifier Source: org_study_id