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Heated Tobacco Product

Cohort 9: HTP device with mode A (20023145) and non-combusted cigarette variant 42001402 for Tobacco Use

N/A
Recruiting
Research Sponsored by RAI Services Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights

Study 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.

Eligible Conditions
  • Tobacco Use
  • Smoking
  • Tobacco Smoking

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Real-time and time-weighted average (TWA) concentrations of Acetaldehyde
Real-time and time-weighted average (TWA) concentrations of Ammonia (NH3)
Real-time and time-weighted average (TWA) concentrations of Benzene
+5 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: Cohort 9: HTP device with mode A (20023145) and non-combusted cigarette variant 42001402Experimental Treatment1 Intervention
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.
Group II: Cohort 8: HTP device with mode B (20022187) and non-combusted cigarette variant 40007386Experimental Treatment1 Intervention
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.
Group III: Cohort 7: HTP device with mode A (20023145) and non-combusted cigarette variant 40007386Experimental Treatment1 Intervention
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.
Group IV: Cohort 6: HTP device with mode B (20022187) and non-combusted cigarette variant 42001399Experimental Treatment1 Intervention
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.
Group V: Cohort 5: HTP device with mode A (20023145) and non-combusted cigarette variant 42001399Experimental Treatment1 Intervention
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.
Group VI: Cohort 4: HTP device with mode B (20022187) and non-combusted cigarette variant 42001401Experimental Treatment1 Intervention
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.
Group VII: Cohort 3: HTP device with mode A (20023145) and non-combusted cigarette variant 42001401Experimental Treatment1 Intervention
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.
Group VIII: Cohort 2: Newport BoxExperimental Treatment1 Intervention
Subjects will self-assign to a Cohort 2 based on their self-reported use of Newport as their usual brand of combustible cigarettes.
Group IX: Cohort 1: Marlboro Gold BoxExperimental Treatment1 Intervention
Subjects will self-assign to a Cohort 1 based on their self-reported use of Marlboro Gold as their usual brand of combustible cigarettes.
Group X: Cohort 10: HTP device with mode B (20022187) and non-combusted cigarette variant 42001402Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

RAI Services CompanyLead Sponsor
41 Previous Clinical Trials
7,497 Total Patients Enrolled
27 Trials studying Tobacco Use
4,200 Patients Enrolled for Tobacco Use
Gary Dull, PhDStudy DirectorRAIS
4 Previous Clinical Trials
616 Total Patients Enrolled
4 Trials studying Tobacco Use
616 Patients Enrolled for Tobacco Use

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
CSD200902: Assessment of Indoor Air Quality for a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in an Environmental Testing Chamber
2022. "CSD200902: Assessment of Indoor Air Quality for a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in an Environmental Testing Chamber". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05363254.
~41 spots leftby Apr 2025
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