CSD200902: Assessment of Indoor Air Quality for a Heated Tobacco Product With Four Non-Combusted … (NCT05363254) | Clinical Trial Compass
CompletedNot Applicable
CSD200902: Assessment of Indoor Air Quality for a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in an Environmental Testing Chamber
United States120 participantsStarted 2022-05-23
Plain-language 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). Evaluation of SHS constituents detected during non-smoking sessions will be performed as a control.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
✓. 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.
✓. 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.
Exclusion criteria
What they're measuring
1
Real-time and time-weighted average (TWA) concentrations of Acetaldehyde
Timeframe: 20 minutes
2
Real-time and time-weighted average (TWA) concentrations of Ammonia (NH3)
Timeframe: 20 minutes
3
Real-time and time-weighted average (TWA) concentrations of Benzene
Timeframe: 20 minutes
4
Real-time and time-weighted average (TWA) concentrations of Carbon monoxide (CO)
Timeframe: 20 minutes
5
Real-time and time-weighted average (TWA) concentrations of Formaldehyde
Timeframe: 20 minutes
6
Real-time and time-weighted average (TWA) concentrations of Nicotine
Timeframe: 20 minutes
7
Real-time and time-weighted average (TWA) concentrations of Toluene
Timeframe: 20 minutes
8
Real-time and time-weighted average (TWA) concentrations of Respirable suspended particulates (RSP) (PM2.5)
. 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.
✕. 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.