Heated tobacco study: can it cut cigarette toxins?
NCT ID NCT07443631
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study looks at whether adult smokers who switch to a heated tobacco device (called THS or TP18) have lower levels of harmful chemicals in their body compared to those who keep smoking regular cigarettes. About 108 smokers will be monitored over a week in a clinic and then at home. The goal is to see if these devices can reduce exposure to toxins found in cigarette smoke.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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108 people
The number who actually took part.
- Started
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Feb 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant has signed the ICF and understands the information provided in it. * Participant is male or female and between 21 and 65 years old (inclusive). * Participant has been a smoker for at least 2 years prior to the screening visit and is willing to switch to THS and TP18. * Participant has smoked on average ≥10 commercially available CIGs/day over the last 30 days. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL). * Participant does not plan to quit smoking within the next three months. * Participant is available for the entire study period and willing to comply with the study procedures, including product use assignments and periods of abstinence from any nicotine/tobacco-containing products, and willing to adhere to a standardized diet (during confinement period and during overnight stays on Day 30 and Day 60). Exclusion Criteria: * As per the Investigator's judgment, the participant cannot participate in the study for any reason other than medical (e.g., psychological, social reason). * Participant is legally incompetent, or physically or mentally incapable of giving consent (e.g., in emergency situations, under guardianship, prisoners). * Participant has a health condition which requires medication or any other clinically relevant finding based on available assessments from the Screening period (e.g., safety panel, pulmonary function test, vital signs, physical examination, ECG, and medical history), as determined by the Principal Investigator or designee. * Participant experienced within 30 days prior to screening/admission a body temperature \>37.9°C or an acute illness (e.g., upper respiratory-tract infection, viral infection, etc.). * According to the Investigator's judgment, the participant has medical conditions that require or will require medical intervention (e.g., initiation of treatment, surgery, hospitalization) during the study period, which may interfere with study participation and/or study results. * Participant uses medication that aids in smoking cessation. * Participant experiences difficulty with venipuncture and/or poor venous access. * Participant has a hemoglobin level \< 11.0 g/dL for females and \< 12.0 g/dL for males at the Screening visit. * Participant has a positive nitrite urinary test at screening or on admission day (Day -2) * Participant has donated blood or received whole blood or blood products within the past 3 months. * BMI \< 18.5 kg/m2 or ≥ 32.0 kg/m2. * Positive serology test for HIV 1/2, HBV, or HCVa. * Participant has a positive alcohol breath test and/or has a history of alcohol disorder that could interfere with their participation in the study. * The participant has a positive urine drug test. * Participant or one of their family members is a current or former employee of the tobacco industry, manufacturing or distributing e-cigarettes or other nicotine/tobacco-containing products. * A participant or a family member is an employee of the investigational site or of any other parties involved in the study. * Participant has participated in another clinical study within 30 days or within a period equivalent to five half-lives of the investigational product from that study, whichever is longer. . * Participant has been previously screened or enrolled in this study (unless they are alternate subjects). * Female participant is pregnant (does not have negative pregnancy tests at screening and/or at admission) or is breastfeeding. * For women of childbearing potential only and males: participant does not agree to use an acceptable method of effective contraception.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Celerion
Belfast, BT9 6AD, United Kingdom
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Other studies related to the condition(s) this trial covers.
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