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Heated tobacco products put to the test: will they satisfy smokers?

NCT ID NCT07267195

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will enroll 40 healthy adult smokers to compare how much they crave different tobacco products. Participants will try heated tobacco devices, their usual cigarettes, and nicotine gum in a clinic setting. Researchers will measure their desire to smoke and nicotine levels in the blood. The goal is to understand the abuse potential of these new products.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Heated tobacco products (HTPs) and nicotine gum
What this could lead to
If successful, this study could help regulators understand whether heated tobacco products are less addictive than cigarettes.
What could go wrong
This is a small, early-stage study with only 40 people, so results may not apply to the general population. It measures short-term cravings, not long-term addiction or health effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

21 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English. * Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent. * Smokes combustible, filtered, non-menthol (Arm 1 only) or menthol cigarettes (Arm 2 only), 83 mm to 100 mm in length as primary source of tobacco. Smokers who also use other tobacco products (e.g., ENDS, smokeless tobacco, HTPs) will not be excluded from study participation, * Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the PI. * Agrees to smoke the same UB cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand and style currently smoked most frequently by the participant. * Expired breath carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at Screening and at check-in (Day -1). * Positive urine cotinine test (e.g., \>200 ng/mL) via dipstick at Screening. * Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6-30 minutes" (Heatherton et al., 1991). * Willing to use the UB cigarette, Study IPs, and Nicorette® nicotine gum during the study period. * Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each of four Test Sessions. * Females must be willing to use a form of contraception acceptable to the PI from the time of signing the ICF until End-of-Study. * Examples of acceptable means of birth control are, but not limited to: * Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral * oophorectomy, bilateral salpingectomy); * physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with * spermicide; * non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs * (e.g., Mirena or Kyleena); * vasectomized partner; or * post-menopausal and not on hormone replacement therapy * abstinence. * Males must use an acceptable method of birth control from Day -1 "check-in" until the End-of-Study, unless they have had a vasectomy or are abstinent from heterosexual intercourse, or their female partner is not able to bear children. * Agrees to an in-clinic confinement of 10 days (9 nights). * BMI within 18.0 to 40.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at Screening). Exclusion Criteria: * Individuals or their family members that have ongoing litigation with tobacco company(ies). * Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study participant unsuitable to participate in this clinical study. * History, presence of, or clinical laboratory test results indicating diabetes. * Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion. * History or presence of bleeding or clotting disorders. * Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed. * Systolic BP of \> 160 mmHg or a diastolic BP of \> 95 mmHg, measured after being seated for 5 minutes at Screening or at check-in Day -1. * Weight of \> 50.0 kg at Screening. * Hemoglobin level is \> 12.5 g/dL for females or \> 13.0 g/dL for males at Screening. * Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study. * Has positive urine drug screen or alcohol test (urine or breath) at Screening or at Check-in to the Assessment Phase (Day -1), with the exception of positive results for tetrahydrocannabinol (THC). If positive for THC at check-in (Day -1), a cannabis intoxication evaluation will be performed, and inclusion will be at the discretion of the PI. * Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV). * Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), GLP-1 agonists (e.g., Mounjaro®, Ozempic®, Wegovy®), or lobelia extract within (≤) 30 days prior to signing the informed consent. * Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous quit attempt within (≤) 30 days prior to signing the informed consent. * Any use of daily aspirin (≥ 325 mg) or any use of other anticoagulants. * Individuals ≥ 35 years of age currently using systemic, testosterone, estrogen-containing contraception or hormone replacement therapy. * Whole blood donation or lost blood or blood products in excess of 500 mL within 8 weeks (≤ 56 days) prior to signing the informed consent and between Screening and check-in Day -1. * Plasma donation within (≤) 7 days prior to signing the informed consent and between Screening and check-in Day -1. * Employed by a tobacco or nicotine company, the study site, or handles raw, unpackaged tobacco- or nicotine-containing products as part of their job. * Has used an investigational drug, device, biologic, or tobacco/nicotine product in a previous clinical study within 30 days or 5 times the half-life of the product (whichever is longer) prior to Screening. * Drinks more than 21 servings of alcoholic beverages per week. * Determined by the PI to be inappropriate for this study.

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Conditions

The condition(s) this trial relates to.

nicotine dependence Smoking Tobacco Smoking Tobacco Use

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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Other studies related to the condition(s) this trial covers.