Tobacco UseNCT05363254
CSD200902: Assessment of Indoor Air Quality for a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in an Environmental Testing Chamber
A study testing Marlboro Gold Box, Newport Box and Non-combusted cigarette variant 42001401 in people with Tobacco Use and Smoking, run by RAI Services Company at 1 site in United States.
Trial summary
This is a single-center, open-label, parallel-cohort study to measure and compare the levels of selected secondhand smoke (SHS) constituents of a heated tobacco product (HTP) against combustible cigarettes (CC) after ad libitum smoking sessions by generally healthy smokers in an environmental testing chamber (ETC). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Smoking, Tobacco Smoking
- What is being tested?
- Marlboro Gold Box, Newport Box and Non-combusted cigarette variant 42001401
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2022to 30 Jul 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete any questionnaires written in English.
- Generally healthy male or female adults, 21 years of age or older, inclusive, at the time of signing the ICF.
- Self-reports at the Screening Visit smoking at least 5 cigarettes per day and inhaling the smoke, for at least 3 months prior to the Screening Visit. Users of HTPs that smoke at least 5 sticks per day will also be allowed into the study. Dual users of combustible cigarettes (CC) and HTPs (either 5 combustible cigarettes or 5 HTP sticks per day, or a combination of 5 CC/HTP products per day) will also be allowed into the study.
- Positive urine cotinine test at the Screening Visit.
- Smokes any commercially available brand cigarette as their UB. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the subject. Users of HTPs will also be allowed into the study. Specific brand users must meet the following cohort-specific requirements:
- Cohort 1: Self-reports smoking Marlboro Gold Box as their UB and willing to smoke self-provided UB cigarettes for the duration of the study.
Show all 20Show fewer
- Cohort 2: Self-reports smoking Newport Box as their UB and willing to smoke self-provided UB cigarettes for the duration of the study.
- Cohorts 3 through 8: Self-reports smoking any style of menthol cigarette as their UB and willing to use a menthol non-combusted cigarette variant ad libitum for the duration of the study. Users of menthol HTPs will also be allowed into this cohort.
- Cohorts 9 and 10: Self-reports smoking any style of non-menthol cigarette as their UB and willing to use a non-menthol non-combusted cigarette variant ad libitum for the duration of the study. Users of non-menthol HTPs will also be allowed into this cohort.
- For Cohorts 3 through 10: Willing to use the HTP IP during the 2-week at-home ad libitum familiarization period in place of their UB, during the 10 chamber test sessions at the ETC, and at-home during the 2-week period of Chamber Visits in place of their UB.
- Females must be willing to use a form of contraception acceptable to the Principal Investigator (PI) from the time of signing the ICF until Study Discharge. 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.
- Males must use an acceptable method of birth control from Visit 1 until the end of the study, unless they have had a vasectomy or are abstinent from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation), or their female partner is not able to bear children.
- Able to safely perform the required study procedures, as determined by the PI.
Who cannot join
- 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 of, presence of, or clinical laboratory test results indicating diabetes.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes.
- 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 allowed at the PI's discretion, pending approval from the Medical Monitor.
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that have been surgically and/or cryogenically removed.
- Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to the signing of informed consent.
Show all 16Show fewer
- 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 the ICF in the current study.
- Females who have a positive pregnancy test, or who are pregnant, are breastfeeding, or intend to become pregnant during the course of the study.
- Subjects ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at the Screening Visit or Enrollment Visit, 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.
- Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous attempt within (≤) 30 days prior to signing the ICF.
- Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol test result at the Screening Visit or Enrollment Visit.
- Employed by a tobacco or nicotine manufacturing company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
- Regularly exposed to solvent fumes or gasoline (e.g., painter, gas-station mini-mart employee).
- History of clinically significant claustrophobia.
- Determined by the PI to be inappropriate for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Atlanta
Stockbridge, Georgia, 30281
About this study
Official title: CSD200902: A Study to Assess Indoor Air Quality for a Heated Tobacco Product (20023145 and 20022187) With Four Non-Combusted Cigarette Variants (40007386, 42001399, 42001401, 42001402) in an Environmental Testing Chamber
This is a single-center, open-label, parallel-cohort study to measure and compare the levels of selected secondhand smoke (SHS) constituents of a heated tobacco product (HTP) against combustible cigarettes (CC) after ad libitum smoking sessions by generally healthy smokers in an environmental testing chamber (ETC). Evaluation of SHS constituents detected during non-smoking sessions will be performed as a control.
Read the detailed description
This study will recruit smokers of both non-menthol and menthol combustible cigarettes, and will allow users of non-menthol and menthol HTPs, and dual users of non-menthol and menthol CCs and HTPs. Safety will be monitored throughout the study by the Principal Investigator (PI) (or designee) by assessing adverse events (AEs), vital sign measurements, standard physical examinations (including oral examinations), electrocardiograms (ECGs), changes in clinical laboratory test results, and pregnancy testing.
Potential subjects will complete a pre-screening telephone interview and a Screening Visit to assess their eligibility within 45 days prior to the Enrollment Visit. The Enrollment visit will occur at least 2 weeks prior to the start of the Chamber Visits. Subjects will be assigned to one of the ten study cohorts based on reported usual brand (UB) CCs and/or HTPs. Cohorts 1 and 2 will use UB CC, Marlboro Gold Box or Newport Box. Subjects in Cohorts 3 through 10 will be assigned to either a non-menthol or menthol HTP investigational products (IP) flavor cohort depending upon past flavor usage history. Subjects will either be assigned to the non-menthol HTP IP or to one of the three menthol HTP IPs after sampling or trying the three menthol HTP IPs and determining which menthol product they would like to use for the length of the study. Once a particular cohort has reached full enrollment, that flavor will no longer be available for sampling and selection. Subjects will be instructed not to use UB CC or HTP during the study.
Subjects assigned to Cohorts 3 through 10 will participate in a 2-week HTP IP familiarization period (prior to Chamber Visit 1), during which subjects will be provided sufficient HTP IP for at-home ad libitum use. The HTP IP includes a battery-powered device, which electronically heats but does not burn tobacco, and requires a non-combusted cigarette, which is inserted into and heated by the HTP device during use. Once heated, the user can begin puffing in the same way as with a CC, on the filter end of the non-combusted cigarette.
- Conditions
- Tobacco Use, Smoking, Tobacco Smoking
- Being tested
- Marlboro Gold Box, Newport Box, Non-combusted cigarette variant 42001401, Non-combusted cigarette variant 42001399, Non-combusted cigarette variant 40007386
- Medical subject headings
- Tobacco Use, Smoking, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marlboro Gold BoxOther
A combustible cigarette
Newport BoxOther
A combustible cigarette
Non-combusted cigarette variant 42001401Other
A menthol flavor variant of a non-combusted cigarette (42001401)
Non-combusted cigarette variant 42001399Other
A menthol flavor variant of a non-combusted cigarette (42001399)
Non-combusted cigarette variant 40007386Other
A menthol flavor variant of a non-combusted cigarette (40007386)
Non-combusted cigarette variant 42001402Other
A non-menthol flavor variant of a non-combusted cigarette (42001402)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Marlboro Gold Box | Experimental | Subjects will self-assign to a Cohort 1 based on their self-reported use of Marlboro Gold as their usual brand of combustible cigarettes. Receives: Other: Marlboro Gold Box |
| Cohort 2: Newport Box | Experimental | Subjects will self-assign to a Cohort 2 based on their self-reported use of Newport as their usual brand of combustible cigarettes. Receives: Other: Newport Box |
| Cohort 3: HTP device with mode A (20023145) and non-combusted cigarette variant 42001401 | Experimental | Subjects will self-assign to one of 6 menthol flavor variant cohorts (Cohort 3 - 8) of non-combusted cigarette products based on their self-reported flavor usage history and a trial use of the 3 menthol flavor variants. Receives: Other: Non-combusted cigarette variant 42001401 |
| Cohort 4: HTP device with mode B (20022187) and non-combusted cigarette variant 42001401 | Experimental | Subjects will self-assign to one of 6 menthol flavor variant cohorts (Cohort 3 - 8) of non-combusted cigarette products based on their self-reported flavor usage history and a trial use of the 3 menthol flavor variants. Receives: Other: Non-combusted cigarette variant 42001401 |
| Cohort 5: HTP device with mode A (20023145) and non-combusted cigarette variant 42001399 | Experimental | Subjects will self-assign to one of 6 menthol flavor variant cohorts (Cohort 3 - 8) of non-combusted cigarette products based on their self-reported flavor usage history and a trial use of the 3 menthol flavor variants. Receives: Other: Non-combusted cigarette variant 42001399 |
| Cohort 6: HTP device with mode B (20022187) and non-combusted cigarette variant 42001399 | Experimental | Subjects will self-assign to one of 6 menthol flavor variant cohorts (Cohort 3 - 8) of non-combusted cigarette products based on their self-reported flavor usage history and a trial use of the 3 menthol flavor variants. Receives: Other: Non-combusted cigarette variant 42001399 |
| Cohort 7: HTP device with mode A (20023145) and non-combusted cigarette variant 40007386 | Experimental | Subjects will self-assign to one of 6 menthol flavor variant cohorts (Cohort 3 - 8) of non-combusted cigarette products based on their self-reported flavor usage history and a trial use of the 3 menthol flavor variants. Receives: Other: Non-combusted cigarette variant 40007386 |
| Cohort 8: HTP device with mode B (20022187) and non-combusted cigarette variant 40007386 | Experimental | Subjects will self-assign to one of 6 menthol flavor variant cohorts (Cohort 3 - 8) of non-combusted cigarette products based on their self-reported flavor usage history and a trial use of the 3 menthol flavor variants. Receives: Other: Non-combusted cigarette variant 40007386 |
| Cohort 9: HTP device with mode A (20023145) and non-combusted cigarette variant 42001402 | Experimental | Subjects will self-assign to one of 2 non-menthol flavor variant cohorts (Cohort 9 and 10) of non-combusted cigarette products based on their self-reported flavor usage history. Receives: Other: Non-combusted cigarette variant 42001402 |
| Cohort 10: HTP device with mode B (20022187) and non-combusted cigarette variant 42001402 | Experimental | Subjects will self-assign to one of 2 non-menthol flavor variant cohorts (Cohort 9 and 10) of non-combusted cigarette products based on their self-reported flavor usage history. Receives: Other: Non-combusted cigarette variant 42001402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time and time-weighted average (TWA) concentrations of Acetaldehyde
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Measured: 20 minutes
Real-time and time-weighted average (TWA) concentrations of Ammonia (NH3)
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Measured: 20 minutes
Real-time and time-weighted average (TWA) concentrations of Benzene
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Measured: 20 minutes
Real-time and time-weighted average (TWA) concentrations of Carbon monoxide (CO)
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Measured: 20 minutes
Real-time and time-weighted average (TWA) concentrations of Formaldehyde
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Measured: 20 minutes
Real-time and time-weighted average (TWA) concentrations of Nicotine
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Measured: 20 minutes
Real-time and time-weighted average (TWA) concentrations of Toluene
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Measured: 20 minutes
Real-time and time-weighted average (TWA) concentrations of Respirable suspended particulates (RSP) (PM2.5)
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start23 May 2022
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by RAI Services CompanyThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Dull, PhD, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363254
- Sponsor's protocol ID
- CSD200902
- Status last verified
- Jun 2022
- First submitted
- 2 May 2022
- Last updated
- 30 Apr 2024
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD200902: A Study to Assess Indoor Air Quality for a Heated Tobacco Product (20023145 and 20022187) With Four Non-Combusted Cigarette Variants (40007386, 42001399, 42001401, 42001402) in an Environmental Testing Chamber
- ClinicalTrials.gov ID
- NCT05363254
- Acronym / sponsor ID
- CSD200902
- Conditions
- Tobacco Use, Smoking, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 May 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 5 May 2022 (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 single-center, open-label, parallel-cohort study to measure and compare the levels of selected secondhand smoke (SHS) constituents of a heated tobacco product (HTP) against combustible cigarettes (CC) after ad libitum smoking sessions by generally healthy smokers in an environmental testing chamber (ETC). Evaluation of SHS constituents detected during non-smoking sessions will be performed as a control.
Detailed description
This study will recruit smokers of both non-menthol and menthol combustible cigarettes, and will allow users of non-menthol and menthol HTPs, and dual users of non-menthol and menthol CCs and HTPs. Safety will be monitored throughout the study by the Principal Investigator (PI) (or designee) by assessing adverse events (AEs), vital sign measurements, standard physical examinations (including oral examinations), electrocardiograms (ECGs), changes in clinical laboratory test results, and pregnancy testing.
Potential subjects will complete a pre-screening telephone interview and a Screening Visit to assess their eligibility within 45 days prior to the Enrollment Visit. The Enrollment visit will occur at least 2 weeks prior to the start of the Chamber Visits. Subjects will be assigned to one of the ten study cohorts based on reported usual brand (UB) CCs and/or HTPs. Cohorts 1 and 2 will use UB CC, Marlboro Gold Box or Newport Box. Subjects in Cohorts 3 through 10 will be assigned to either a non-menthol or menthol HTP investigational products (IP) flavor cohort depending upon past flavor usage history. Subjects will either be assigned to the non-menthol HTP IP or to one of the three menthol HTP IPs after sampling or trying the three menthol HTP IPs and determining which menthol product they would like to use for the length of the study. Once a particular cohort has reached full enrollment, that flavor will no longer be available for sampling and selection. Subjects will be instructed not to use UB CC or HTP during the study.
Subjects assigned to Cohorts 3 through 10 will participate in a 2-week HTP IP familiarization period (prior to Chamber Visit 1), during which subjects will be provided sufficient HTP IP for at-home ad libitum use. The HTP IP includes a battery-powered device, which electronically heats but does not burn tobacco, and requires a non-combusted cigarette, which is inserted into and heated by the HTP device during use. Once heated, the user can begin puffing in the same way as with a CC, on the filter end of the non-combusted cigarette.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Marlboro Gold Box | Experimental | Other: Marlboro Gold BoxSubjects will self-assign to a Cohort 1 based on their self-reported use of Marlboro Gold as their usual brand of combustible cigarettes. |
| Cohort 2: Newport Box | Experimental | Other: Newport BoxSubjects will self-assign to a Cohort 2 based on their self-reported use of Newport as their usual brand of combustible cigarettes. |
| Cohort 3: HTP device with mode A (20023145) and non-combusted cigarette variant 42001401 | Experimental | Other: Non-combusted cigarette variant 42001401Subjects will self-assign to one of 6 menthol flavor variant cohorts (Cohort 3 - 8) of non-combusted cigarette products based on their self-reported flavor usage history and a trial use of the 3 menthol flavor variants. |
| Cohort 4: HTP device with mode B (20022187) and non-combusted cigarette variant 42001401 | Experimental | Other: Non-combusted cigarette variant 42001401Subjects will self-assign to one of 6 menthol flavor variant cohorts (Cohort 3 - 8) of non-combusted cigarette products based on their self-reported flavor usage history and a trial use of the 3 menthol flavor variants. |
| Cohort 5: HTP device with mode A (20023145) and non-combusted cigarette variant 42001399 | Experimental | Other: Non-combusted cigarette variant 42001399Subjects will self-assign to one of 6 menthol flavor variant cohorts (Cohort 3 - 8) of non-combusted cigarette products based on their self-reported flavor usage history and a trial use of the 3 menthol flavor variants. |
| Cohort 6: HTP device with mode B (20022187) and non-combusted cigarette variant 42001399 | Experimental | Other: Non-combusted cigarette variant 42001399Subjects will self-assign to one of 6 menthol flavor variant cohorts (Cohort 3 - 8) of non-combusted cigarette products based on their self-reported flavor usage history and a trial use of the 3 menthol flavor variants. |
| Cohort 7: HTP device with mode A (20023145) and non-combusted cigarette variant 40007386 | Experimental | Other: Non-combusted cigarette variant 40007386Subjects will self-assign to one of 6 menthol flavor variant cohorts (Cohort 3 - 8) of non-combusted cigarette products based on their self-reported flavor usage history and a trial use of the 3 menthol flavor variants. |
| Cohort 8: HTP device with mode B (20022187) and non-combusted cigarette variant 40007386 | Experimental | Other: Non-combusted cigarette variant 40007386Subjects will self-assign to one of 6 menthol flavor variant cohorts (Cohort 3 - 8) of non-combusted cigarette products based on their self-reported flavor usage history and a trial use of the 3 menthol flavor variants. |
| Cohort 9: HTP device with mode A (20023145) and non-combusted cigarette variant 42001402 | Experimental | Other: Non-combusted cigarette variant 42001402Subjects will self-assign to one of 2 non-menthol flavor variant cohorts (Cohort 9 and 10) of non-combusted cigarette products based on their self-reported flavor usage history. |
| Cohort 10: HTP device with mode B (20022187) and non-combusted cigarette variant 42001402 | Experimental | Other: Non-combusted cigarette variant 42001402Subjects will self-assign to one of 2 non-menthol flavor variant cohorts (Cohort 9 and 10) of non-combusted cigarette products based on their self-reported flavor usage history. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete any questionnaires written in English.
- Generally healthy male or female adults, 21 years of age or older, inclusive, at the time of signing the ICF.
- Self-reports at the Screening Visit smoking at least 5 cigarettes per day and inhaling the smoke, for at least 3 months prior to the Screening Visit. Users of HTPs that smoke at least 5 sticks per day will also be allowed into the study. Dual users of combustible cigarettes (CC) and HTPs (either 5 combustible cigarettes or 5 HTP sticks per day, or a combination of 5 CC/HTP products per day) will also be allowed into the study.
- Positive urine cotinine test at the Screening Visit.
- Smokes any commercially available brand cigarette as their UB. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the subject. Users of HTPs will also be allowed into the study. Specific brand users must meet the following cohort-specific requirements:
Key exclusion criteria (16 listed)
- 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 of, presence of, or clinical laboratory test results indicating diabetes.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes.
- 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 allowed at the PI's discretion, pending approval from the Medical Monitor.
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that have been surgically and/or cryogenically removed.
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 |
|---|---|---|
| Marlboro Gold BoxA combustible cigarette | Other | Cohort 1: Marlboro Gold Box |
| Newport BoxA combustible cigarette | Other | Cohort 2: Newport Box |
| Non-combusted cigarette variant 42001401A menthol flavor variant of a non-combusted cigarette (42001401) | Other | Cohort 3: HTP device with mode A (20023145) and non-combusted cigarette variant 42001401, Cohort 4: HTP device with mode B (20022187) and non-combusted cigarette variant 42001401 |
| Non-combusted cigarette variant 42001399A menthol flavor variant of a non-combusted cigarette (42001399) | Other | Cohort 5: HTP device with mode A (20023145) and non-combusted cigarette variant 42001399, Cohort 6: HTP device with mode B (20022187) and non-combusted cigarette variant 42001399 |
| Non-combusted cigarette variant 40007386A menthol flavor variant of a non-combusted cigarette (40007386) | Other | Cohort 7: HTP device with mode A (20023145) and non-combusted cigarette variant 40007386, Cohort 8: HTP device with mode B (20022187) and non-combusted cigarette variant 40007386 |
| Non-combusted cigarette variant 42001402A non-menthol flavor variant of a non-combusted cigarette (42001402) | Other | Cohort 10: HTP device with mode B (20022187) and non-combusted cigarette variant 42001402, Cohort 9: HTP device with mode A (20023145) and non-combusted cigarette variant 42001402 |
Primary outcome
Real-time and time-weighted average (TWA) concentrations of Acetaldehyde
Time frame: 20 minutes
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Real-time and time-weighted average (TWA) concentrations of Ammonia (NH3)
Time frame: 20 minutes
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Real-time and time-weighted average (TWA) concentrations of Benzene
Time frame: 20 minutes
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Real-time and time-weighted average (TWA) concentrations of Carbon monoxide (CO)
Time frame: 20 minutes
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Real-time and time-weighted average (TWA) concentrations of Formaldehyde
Time frame: 20 minutes
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Real-time and time-weighted average (TWA) concentrations of Nicotine
Time frame: 20 minutes
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Real-time and time-weighted average (TWA) concentrations of Toluene
Time frame: 20 minutes
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
Real-time and time-weighted average (TWA) concentrations of Respirable suspended particulates (RSP) (PM2.5)
Time frame: 20 minutes
To assess differences in levels of selected Secondhand smoke (SHS) constituents after ad libitum human use of each non-combusted cigarette variant heated by the HTP device in an environmental testing chamber compared to after ad libitum human smoking of combustible cigarettes
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 30 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
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
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
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.
Gary Dull, PhD study director
RAIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marlboro Gold Box, Newport Box and Non-combusted cigarette variant 42001401 in people with Tobacco Use and Smoking, run by RAI Services Company at 1 site 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 20 inclusion and 16 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Real-time and time-weighted average (TWA) concentrations of Acetaldehyde (time frame: 20 minutes). The study lists 8 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 30 Apr 2024.