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Pharmacokinetic and Subjective Effects of Heated Tobacco Products

NCT06356610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-27

Study results available
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Summary

This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK (pharmacokinetic) and subjective effects of HTPs (Heated Tobacco Products) comprised of 2 menthol varieties and 2 tobacco flavor varieties (Ploom® HTPs, Japan Tobacco Inc.) in adult menthol and non-menthol combustible cigarette smokers (males and females between the ages of 22 and 65). The study will include participants' UBCC (Usual Brand Combustible Cigarette) and a nicotine gum (Nicorette®) as high and low abuse liability reference products, respectively, to the HTP. Study participation is expected to last up to 34 days, including a 28-day screening period (that includes a 5-day at-home HTP product trial period), and a 6-day in-clinic confinement period (from Check-in \[Day -1\] through the end-of-study \[EOS\] visit on Day 6).

Conditions

  • Tobacco Use

Interventions

OTHER

Product A

Use of Product A in controlled use and ad libitum use sessions

OTHER

Product B

Use of Product B in controlled use and ad libitum use sessions

OTHER

Product C

Use of Product C in controlled use and ad libitum use sessions

OTHER

Product D

Use of Product D in controlled use and ad libitum use sessions

OTHER

Product E

Use of Product E in controlled use and ad libitum use sessions

OTHER

Product F

Use of Product F in controlled use and ad libitum use sessions

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Altria Client Services LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-06
Primary Completion
2024-04-14
Completion
2024-12-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06356610 on ClinicalTrials.gov