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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Cohort 5: HTP device with mode A (20023145) and non-combusted cigarette variant 42001399 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marlboro Gold Box | Other | A combustible cigarette |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 |
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Inclusion Criteria:
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:
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:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Dull, PhD | RAIS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
|
| Newport Box |
| Other |
A combustible cigarette |
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| Non-combusted cigarette variant 42001401 | Other | A menthol flavor variant of a non-combusted cigarette (42001401) |
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| Non-combusted cigarette variant 42001399 | Other | A menthol flavor variant of a non-combusted cigarette (42001399) |
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| Non-combusted cigarette variant 40007386 | Other | A menthol flavor variant of a non-combusted cigarette (40007386) |
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| Non-combusted cigarette variant 42001402 | Other | A non-menthol flavor variant of a non-combusted cigarette (42001402) |
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| 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 | 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 | 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 | 20 minutes |
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D012907 | Smoking |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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