Status:
COMPLETED
A Consumer Use Behavior Study to Evaluate Puffing Topography and Average Daily Consumption of Heated Tobacco Products
Lead Sponsor:
RAI Services Company
Collaborating Sponsors:
IPSOS
Conditions:
Smoking Cigarette
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices, with three variants of HTP consumables ("sticks,"), collectively referred to as the study inve...
Detailed Description
This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices (glo and glo plus), with three variants of HTP consumables ("sticks," under the brand name "vir...
Eligibility Criteria
Inclusion
- Be aged 21-65 years (inclusive)
- 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
- Women who self-report they are pregnant or breastfeeding or could become pregnant or start breastfeeding in the next three months from the study start date.
- 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:
- Advertising
- Journalism
- Media
- Insurance
- Marketing
- Market Research
- Manufacturer or retailer of tobacco or vapor products
- Public Relations
- Sale of Alcohol
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2025
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT07175987
Start Date
September 1 2025
End Date
September 25 2025
Last Update
December 23 2025
Active Locations (1)
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1
Channing Hall
Sheffield, United Kingdom