SmokingNCT05142436
BAT3221032: A Study to Evaluate the Effects of Switching From Cigarette Smoking to Using One of Five Variants of a Heated Tobacco Product on Biomarkers of Exposure and Biomarkers of Potential Harm in Healthy Subjects
A study testing Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode B, Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B and Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode B in people with Smoking and Tobacco Use, run by British American Tobacco (Investments) Limited at 18 sites in United States.
Trial summary
This is a randomized, controlled, multi-center, open-label, 8-cohort parallel group study to assess changes in select biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH) in generally healthy smokers switching to the study investigational products (IPs), compared to subjects who continue to smoke… Read more about this study
- Who is it for?
- Ages 26 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco Use, Tobacco Smoking
- What is being tested?
- Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode B, Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B and Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 806 participants
- Where
- 18 sitesUnited States
- Study dates
- 13 Jan 2022to 13 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All Subjects
- Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English or Spanish.
- Generally healthy male or female, 26 to 55 years of age, inclusive, at the time of consent.
- Body mass index (BMI) within 18.0 to 40.0 kg/m2, inclusive (minimum weight of at least 110 lbs. [50 kg]) at Screening.
- Agree to abide by the study restrictions and requirements, including use of the assigned product or to undergo smoking cessation, and agree to in-clinic, overnight confinement at Visits 1 and 4.
- Willing to refrain from consuming alcohol within 24 hours prior to Screening and check-in at Visits 1 and 4.
Show all 32Show fewer
- Willing to refrain from consuming cruciferous vegetables and grilled, smoked, fried or barbequed food, and to avoid being in the presence of the cooking of these foods, and to refrain from consuming cured sandwich meats, bacon, salami, and sausages, for 48 hours prior to check-in at Visits 1 and 4.
- Males must be vasectomized, abstinent from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation), or they (or their female partner of childbearing potential) must use acceptable methods of birth control from Visit 1 until the end of the study.
- Females must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until the end of the study.
- Examples of acceptable means of birth control are, but not limited to:
- Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy);
- Established use of oral, implantable, injectable or transdermal methods of contraception associated with inhibition of ovulation;
- 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;
- Abstinence from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation); and
- Post-menopausal and not on hormone replacement therapy.
- Cohorts 1 to 7
- Smokes manufactured combustible, filtered, non-menthol (cohorts 1 and 5) or menthol (cohorts 2, 3 and 4) cigarettes (either is acceptable for cohorts 6 and 7), 83 mm to 100 mm in length as their primary source of nicotine.
- Has smoked for at least the five consecutive years prior to Screening. Brief periods of abstinence due to illness, quit attempt (more than 30 days prior to Screening), or clinical study participation (more than 30 days prior to Screening) will be allowed at the discretion of the PI.
- Smokes an average of at least 10 and a maximum of 30 cigarettes per day (CPD) and inhales the smoke.
- Exhaled breath carbon monoxide (eCO) level is ≥ 7 ppm and ≤ 100 ppm at Screening.
- Positive urine cotinine test at Screening.
- If assigned to cohort 1, 2, 3, 4 or 5, willing to use only the study product (HTP) provided to them during the study.
- If assigned to cohort 6, willing to continue to smoke factory-manufactured cigarettes.
- For cohort 7 only, willing to refrain from smoking or using any form of tobacco or nicotine-containing product (other than nicotine replacement therapy (NRT) where agreed as part of their smoking cessation strategy).
- Agree not to allow any other person to use any product provided to them for use during this study, nor to dispose of any product provided to them for use during this study with the exception of the disposal of used HTP sticks or used NRT.
- Cohort 8
- Never have smoked (<100 cigarettes in their life), not have smoked or used any nicotine or tobacco product within 30 days prior to Screening, and will continue not to smoke or use any form of tobacco or nicotine-containing product (including HTPs) for the duration of the study.
- Lives in a non-smoking household and is not employed in a role which regularly exposes them to tobacco smoke (e.g., bar worker).
- Exhaled breath carbon monoxide (eCO) level is < 7 ppm at Screening.
- Negative urine cotinine test at Screening.
Who cannot join
- All Subjects
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease(s), or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes (history of gestational diabetes which is no longer present nor indicated by clinical laboratory test results is acceptable).
- 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 pending approval from the Medical Monitor.
- Subjects who have had an acute illness (e.g., upper respiratory tract infection) requiring treatment within 4 weeks prior to Visit 1 (subjects who had viral infections that resolved ≥ 2 weeks prior to Visit 1 will be admissible).
- Subjects who have received any medications or substances (other than nicotine) which:
Show all 27Show fewer
- interfere with the cyclooxygenase pathway (e.g., anti-inflammatory drugs including aspirin and ibuprofen) within 14 days prior to Visit 1
- are known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 half-lives of the drug (whichever is longer) prior to Visit 1
- 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 blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes.
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- Positive urine/saliva drug screen without evidence of prescribed corresponding concomitant medication(s) at the Screening Visit or Visit 1, with the exception of for tetrahydrocannabinol (THC). If positive for THC, a cannabis intoxication evaluation will be performed at check-in, and inclusion will be at the discretion of the PI or appropriately qualified designee.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- Participation in another clinical trial within (≤) 30 days prior to signing the ICF. The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing informed consent in the current study.
- Subjects who have donated:
- ≥400 mL of blood within 30 days prior to screening, or during the period from signing informed consent to check-in at Visit 1
- plasma in the 7 days prior to screening, or during the period from signing informed consent to the end of study (Visit 4)
- Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
- Has a significant history of alcoholism or drug abuse within 24 months prior to Screening, as determined by the PI, or has a positive urine/breath alcohol test at Screening or Visit 1.
- Determined by the PI to be inappropriate for this study.
- Cohorts 1 to 6
- Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous attempt within 30 days prior to the signing of the ICF.
- 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®), or lobelia extract within 30 days prior to the signing the ICF.
- Cohorts 1 to 7
- Currently uses any nicotine or tobacco product, other than CC, more than one day per week.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Pillar Clinical Research, LLC
Bentonville, Arkansas, 72712
Centricity Research
Columbus, Ohio, 43213
InSite Clinical Research, LLC.
DeSoto, Texas, 75115
High Point Clinical Trials Center
High Point, North Carolina, 27265
AMR Kansas City
Kansas City, Missouri, 64114
AMR Knoxville
Knoxville, Tennessee, 37920
AMR Lexington
Lexington, Kentucky, 40509
Woodland International Research Group
Little Rock, Arkansas, 72211
Bright Research Center
Miami, Florida, 33144
Monroe Biomedical Research
Monroe, North Carolina, 28112
Infinite Clinical Trials
Morrow, Georgia, 30260
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
Pillar Clinical Research
Richardson, Texas, 75080
Woodland Research Northwest
Rogers, Arkansas, 72758
Clinical Trials of Texas
San Antonio, Texas, 78229
Endeavor Clinical Trials
San Antonio, Texas, 78229
QPS Bio-Kinetic
Springfield, Missouri, 65802
About this study
Official title: BAT3221032: A Randomized, Controlled Study to Evaluate the Effects of Switching From Cigarette Smoking to Using One of Five Variants of a Heated Tobacco Product on Biomarkers of Exposure and Biomarkers of Potential Harm in Healthy Subjects
This is a randomized, controlled, multi-center, open-label, 8-cohort parallel group study to assess changes in select biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH) in generally healthy smokers switching to the study investigational products (IPs), compared to subjects who continue to smoke, undergo smoking abstinence, or have never smoked.
Read the detailed description
All subjects will participate in a baseline biomarker assessment and smokers will then be switched to exclusive use of their assigned product (cohorts 1-5), continue to smoke (cohort 6), or smoking cessation (cohort 7), and never-smokers will continue to not smoke (cohort 8). Subjects will be directed to use their assigned product exclusively for 3 months and will participate in study visits throughout the study for safety, product re-supply and collection of samples for biomarker assessments. Throughout the study, subjects will report their daily use of the study IP and/or cigarette smoking.
This study will be ambulatory, with subjects in cohorts 1-7 attending a total of 4 clinic visits (one every approximately 30 days) over a period of 3 months. Subjects in cohorts 1-7 will be confined in the study site overnight the night before their Day 1 (Visit 1, baseline) and Day 90 (Visit 4) visits. The Day 30 (Visit 2) and Day 60 (Visit 3) visits will be non-residential visits for pregnancy testing (female subjects) and product usage assessments and resupply only. Subjects in cohort 8 will attend the clinic for Visit 1 and Visit 4 only, and will be confined in the clinic overnight the night before each of these visits. In addition, all subjects will attend a Screening Visit.
Smokers will be asked to continue smoking their usual brand (UB) cigarettes until randomization (cohorts 1-6) or enrollment (cohort 7) at Visit 1. Never-smokers will be asked to continue not to use any tobacco or nicotine products for the entire study duration.
All subjects will be confined on Visit 1 and will use their UB cigarettes ad libitum during this period (unless required to abstain for specific tests and excluding cohort 8, who will not use any nicotine or tobacco products). Exhaled breath, 24-hour urine and blood samples will be collected and evaluated for baseline BoE and BoPH. Smokers of non-menthol UB cigarettes will then be randomized to cohort 1, 5 or 6; smokers of mentholated UB cigarettes will be randomized to cohort 2, 3, 4 or 6; smokers who intend to quit smoking will be enrolled to cohort 7; and never-smokers will be enrolled to cohort 8.
All subjects will be confined on Visit 4. Subjects in cohorts 1-6 will use their assigned product exclusively, ad libitum during this period (unless required to abstain for specific tests). Other than subjects in cohort 7 who are using nicotine replacement therapy as part of their smoking cessation strategy, subjects in cohorts 7 and 8 will not use any tobacco or nicotine products. Exhaled breath, 24-hour urine and blood samples will be collected and evaluated for BoE and BoPH.
- Conditions
- Smoking, Tobacco Use, Tobacco Smoking
- Being tested
- Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode B, Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B, Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode B, Product D: Non-Combusted Cigarette Variant 40007386 and product use Mode B, Product E: Non-Combusted Cigarette Variant 42001402 and product use Mode A
- Medical subject headings
- Smoking, Tobacco Use, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode BOther
42001402, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B
Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode BOther
42001399, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B
Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode BOther
42001401, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B
Product D: Non-Combusted Cigarette Variant 40007386 and product use Mode BOther
40007386, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B
Product E: Non-Combusted Cigarette Variant 42001402 and product use Mode AOther
42001402, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode A
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Non-combusted cigarette variant 42001402 and product use mode B | Experimental | Subjects randomized to use of a non-combusted cigarette variant and product use mode B Receives: Other: Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode B |
| Cohort 2: Non-combusted cigarette variant 42001399 and product use mode B | Experimental | Subjects randomized to use of a non-combusted cigarette variant and product use mode B Receives: Other: Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B |
| Cohort 3: Non-combusted cigarette variant 42001401 and product use mode B | Experimental | Subjects randomized to use of a non-combusted cigarette variant and product use mode B Receives: Other: Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode B |
| Cohort 4: Non-combusted cigarette variant 40007386 and product use mode B | Experimental | Subjects randomized to use of a non-combusted cigarette variant and product use mode B Receives: Other: Product D: Non-Combusted Cigarette Variant 40007386 and product use Mode B |
| Cohort 5: Non-combusted cigarette variant 42001402 and product use mode A | Experimental | Subjects randomized to use of a non-combusted cigarette variant and product use mode A Receives: Other: Product E: Non-Combusted Cigarette Variant 42001402 and product use Mode A |
| Cohort 6: Usual Brand Cigarettes | No intervention | Subjects randomized to continue to smoke usual brand cigarettes |
| Cohort 7: Assisted Smoking Cessation | No intervention | Subjects assigned to assisted smoking cessation |
| Cohort 8: Never-Smokers | No intervention | Never-smokers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL] + glucuronides)
To quantitively assess differences in biomarker of exposure, Total NNAL, at 90 days between subjects who continue to smoke combustible cigarettes (CC) and subjects who switch to an HTP
Measured: 90 days
Monohydroxybutyl mercapturic acid (MHBMA)
To quantitively assess differences in biomarker of exposure, MHBMA, at 90 days between subjects who continue to smoke CC and subjects who switch to an HTP
Measured: 90 days
3-hydroxypropyl mercapturic acid (3-HPMA)
To quantitively assess differences in biomarker of exposure, 3-HPMA, at 90 days between subjects who continue to smoke CC and subjects who switch to an HTP
Measured: 90 days
S-phenyl mercapturic acid (S-PMA)
To quantitively assess differences in biomarker of exposure, S-PMA, at 90 days between subjects who continue to smoke CC and subjects who switch to an HTP
Measured: 90 days
Carboxyhemoglobin (COHb)
To quantitively assess differences in biomarker of exposure, COHb, at 90 days between subjects who continue to smoke CC and subjects who switch to an HTP
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start13 Jan 2022
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 806 participants (actual)
Sponsor and investigators
- Lead sponsor
- British American Tobacco (Investments) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Nathan Gale, Study director, BAT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142436
- Sponsor's protocol ID
- BAT3221032
- Status last verified
- Dec 2022
- First submitted
- 16 Nov 2021
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BAT3221032: A Randomized, Controlled Study to Evaluate the Effects of Switching From Cigarette Smoking to Using One of Five Variants of a Heated Tobacco Product on Biomarkers of Exposure and Biomarkers of Potential Harm in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05142436
- Acronym / sponsor ID
- BAT3221032
- Conditions
- Smoking, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 806 participants (actual)
- Lead sponsor
- British American Tobacco (Investments) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, controlled, multi-center, open-label, 8-cohort parallel group study to assess changes in select biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH) in generally healthy smokers switching to the study investigational products (IPs), compared to subjects who continue to smoke, undergo smoking abstinence, or have never smoked.
Detailed description
All subjects will participate in a baseline biomarker assessment and smokers will then be switched to exclusive use of their assigned product (cohorts 1-5), continue to smoke (cohort 6), or smoking cessation (cohort 7), and never-smokers will continue to not smoke (cohort 8). Subjects will be directed to use their assigned product exclusively for 3 months and will participate in study visits throughout the study for safety, product re-supply and collection of samples for biomarker assessments. Throughout the study, subjects will report their daily use of the study IP and/or cigarette smoking.
This study will be ambulatory, with subjects in cohorts 1-7 attending a total of 4 clinic visits (one every approximately 30 days) over a period of 3 months. Subjects in cohorts 1-7 will be confined in the study site overnight the night before their Day 1 (Visit 1, baseline) and Day 90 (Visit 4) visits. The Day 30 (Visit 2) and Day 60 (Visit 3) visits will be non-residential visits for pregnancy testing (female subjects) and product usage assessments and resupply only. Subjects in cohort 8 will attend the clinic for Visit 1 and Visit 4 only, and will be confined in the clinic overnight the night before each of these visits. In addition, all subjects will attend a Screening Visit.
Smokers will be asked to continue smoking their usual brand (UB) cigarettes until randomization (cohorts 1-6) or enrollment (cohort 7) at Visit 1. Never-smokers will be asked to continue not to use any tobacco or nicotine products for the entire study duration.
All subjects will be confined on Visit 1 and will use their UB cigarettes ad libitum during this period (unless required to abstain for specific tests and excluding cohort 8, who will not use any nicotine or tobacco products). Exhaled breath, 24-hour urine and blood samples will be collected and evaluated for baseline BoE and BoPH. Smokers of non-menthol UB cigarettes will then be randomized to cohort 1, 5 or 6; smokers of mentholated UB cigarettes will be randomized to cohort 2, 3, 4 or 6; smokers who intend to quit smoking will be enrolled to cohort 7; and never-smokers will be enrolled to cohort 8.
All subjects will be confined on Visit 4. Subjects in cohorts 1-6 will use their assigned product exclusively, ad libitum during this period (unless required to abstain for specific tests). Other than subjects in cohort 7 who are using nicotine replacement therapy as part of their smoking cessation strategy, subjects in cohorts 7 and 8 will not use any tobacco or nicotine products. Exhaled breath, 24-hour urine and blood samples will be collected and evaluated for BoE and BoPH.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Non-combusted cigarette variant 42001402 and product use mode B | Experimental | Other: Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode BSubjects randomized to use of a non-combusted cigarette variant and product use mode B |
| Cohort 2: Non-combusted cigarette variant 42001399 and product use mode B | Experimental | Other: Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode BSubjects randomized to use of a non-combusted cigarette variant and product use mode B |
| Cohort 3: Non-combusted cigarette variant 42001401 and product use mode B | Experimental | Other: Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode BSubjects randomized to use of a non-combusted cigarette variant and product use mode B |
| Cohort 4: Non-combusted cigarette variant 40007386 and product use mode B | Experimental | Other: Product D: Non-Combusted Cigarette Variant 40007386 and product use Mode BSubjects randomized to use of a non-combusted cigarette variant and product use mode B |
| Cohort 5: Non-combusted cigarette variant 42001402 and product use mode A | Experimental | Other: Product E: Non-Combusted Cigarette Variant 42001402 and product use Mode ASubjects randomized to use of a non-combusted cigarette variant and product use mode A |
| Cohort 6: Usual Brand Cigarettes | No intervention | –Subjects randomized to continue to smoke usual brand cigarettes |
| Cohort 7: Assisted Smoking Cessation | No intervention | –Subjects assigned to assisted smoking cessation |
| Cohort 8: Never-Smokers | No intervention | –Never-smokers |
Who may qualify
- Ages
- 26 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (32 listed)
- All Subjects
- Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English or Spanish.
- Generally healthy male or female, 26 to 55 years of age, inclusive, at the time of consent.
- Body mass index (BMI) within 18.0 to 40.0 kg/m2, inclusive (minimum weight of at least 110 lbs. [50 kg]) at Screening.
- Agree to abide by the study restrictions and requirements, including use of the assigned product or to undergo smoking cessation, and agree to in-clinic, overnight confinement at Visits 1 and 4.
Key exclusion criteria (27 listed)
- All Subjects
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease(s), or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes (history of gestational diabetes which is no longer present nor indicated by clinical laboratory test results is acceptable).
- 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 pending approval from the Medical Monitor.
- Subjects who have had an acute illness (e.g., upper respiratory tract infection) requiring treatment within 4 weeks prior to Visit 1 (subjects who had viral infections that resolved ≥ 2 weeks prior to Visit 1 will be admissible).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode B42001402, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B | Other | Cohort 1: Non-combusted cigarette variant 42001402 and product use mode B |
| Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B42001399, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B | Other | Cohort 2: Non-combusted cigarette variant 42001399 and product use mode B |
| Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode B42001401, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B | Other | Cohort 3: Non-combusted cigarette variant 42001401 and product use mode B |
| Product D: Non-Combusted Cigarette Variant 40007386 and product use Mode B40007386, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B | Other | Cohort 4: Non-combusted cigarette variant 40007386 and product use mode B |
| Product E: Non-Combusted Cigarette Variant 42001402 and product use Mode A42001402, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode A | Other | Cohort 5: Non-combusted cigarette variant 42001402 and product use mode A |
Primary outcome
Total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL] + glucuronides)
Time frame: 90 days
To quantitively assess differences in biomarker of exposure, Total NNAL, at 90 days between subjects who continue to smoke combustible cigarettes (CC) and subjects who switch to an HTP
Monohydroxybutyl mercapturic acid (MHBMA)
Time frame: 90 days
To quantitively assess differences in biomarker of exposure, MHBMA, at 90 days between subjects who continue to smoke CC and subjects who switch to an HTP
3-hydroxypropyl mercapturic acid (3-HPMA)
Time frame: 90 days
To quantitively assess differences in biomarker of exposure, 3-HPMA, at 90 days between subjects who continue to smoke CC and subjects who switch to an HTP
S-phenyl mercapturic acid (S-PMA)
Time frame: 90 days
To quantitively assess differences in biomarker of exposure, S-PMA, at 90 days between subjects who continue to smoke CC and subjects who switch to an HTP
Carboxyhemoglobin (COHb)
Time frame: 90 days
To quantitively assess differences in biomarker of exposure, COHb, at 90 days between subjects who continue to smoke CC and subjects who switch to an HTP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Gale study director
BAT
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode B, Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B and Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode B in people with Smoking and Tobacco Use, run by British American Tobacco (Investments) Limited at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL] + glucuronides) (time frame: 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.