A Consumer Use Behavior Study to Measure the Puffing Topography of Heated Tobacco Products

Official title

A Consumer Use Behavior Study to Measure the Puffing Topography of Heated Tobacco Products (Glo and Glo Plus)

Overview

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.

Interventions

• Other P2515910
  Tobacco Flavor
• Other P2512610
  Menthol Flavor

Primary outcome measures

• 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. [Time frame: 5 days]

Secondary outcome measures (6)

• Determine the frequency of use of the glo and glo plus devices in Standard and Boost Mode [Time frame: 5 days]
• Determine the frequency of use of the glo plus pen detached from the charger pack (Study Arm 2 only) [Time frame: 5 days]
• Determine the average daily consumption (ADC) of CC smoked, sticks consumed, and other TNPs used [Time frame: 5 days]
• Determine overall product liking and purchase intent [Time frame: 5 days]
• Characterize demographic characteristics [Time frame: 5 days]
• Determine the safety profile (i.e., adverse events/experiences [AEs]) of the Study IP [Time frame: 5 days]

Eligibility criteria

Inclusion criteria

• Ability to read, understand, and be willing to sign an ICF and complete questionnaires written in English.
• Generally healthy male or female, between age 21-65 years (inclusive at the time of consent), verified with government-issued identification.
• All female (assigned at birth) candidate participants and those who identify as "intersex" or "unknown" during screening who agree to take the pregnancy test on site and receive a negative result, and who affirm at the SEV that they are not pregnant or intending to become pregnant.
• Self-report currently smoking at least five CPD on smoking days in the past 30 days.
• Smoke CC on at least 27 days out of last 30 days.
• Have smoked at least 100 factory-made filtered CC in their lifetime prior to SEV.
• Indicate a willingness to use an HTP.
• 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

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

United Kingdom · 2 centers

• Cheshunt Community Sports Park — Cheshunt
• Channing Hall — Sheffield

Identifiers

NCT: NCT07677280 · PHI252503

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗