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Clinical Trials in the UK / NCT07677280
Starting soon Not applicable

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

NCT07677280 · tracked via the Priya Life Science UK tracker
Sponsor
RAI Services Company
Phase
Not applicable
Started
2026-06
Last updated
2026-06-30

Condition(s) studied

Cigarette Smokers

Investigational drug(s) / intervention(s)

P2515910P2512610

P2515910: Tobacco Flavor

P2512610: Menthol Flavor

Study summary

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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Cheshunt Community Sports Park Cheshunt United Kingdom
Channing Hall Sheffield United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07677280 on ClinicalTrials.gov ↗ ← All trials in the UK