CSD210903: A Study to Determine Subject Puffing Patterns of a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in an Ambulatory Setting

N/A

Waitlist Available

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 14 days

Awards & highlights

No Placebo-Only Group

Summary

This is a multi-center, open-label, parallel-cohort-study to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) combustible cigarette (CC) and/or a UB Heated Tobacco Product (HTP) to one of four investigational products (IPs), across two heating modes, over a 28-day ambulatory period.

Eligible Conditions

Tobacco Use
Tobacco Smoking
Smoking

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Arithmetic Mean

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Non-Menthol with HTP device (20020064)Experimental Treatment1 Intervention

Subjects will self-assign to a non-menthol flavor variant of a non-combusted cigarette product based on their self-reported flavor usage history.

Group II: Cohort 1: Menthol with HTP device (20020064)Experimental Treatment3 Interventions

Subjects will self-assign to one of three menthol flavor variants of non-combusted cigarette products based on their self-reported flavor usage history.

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