Heated Tobacco Products for Tobacco Use

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Altria Client Services LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for adult smokers aged 22 to 65 who regularly use menthol or non-menthol cigarettes. Participants should be interested in trying heated tobacco products (HTPs) and willing to stay in a clinic for six days. Specific eligibility criteria are not provided, but typically include general health requirements and no conflicting medications or conditions.

Treatment Details

The study tests the nicotine delivery and user response of different HTPs compared with regular cigarettes and nicotine gum. It's a controlled study where each participant will try multiple products (2 menthol, 2 tobacco flavors, their usual cigarette brand, and nicotine gum) over several sessions.

6Treatment groups

Experimental Treatment

Group I: Randomization Sequence 6: FAEBDCExperimental Treatment6 Interventions

Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6 day in-clinic period in following order: Reference Product F Test Product A Reference Product E Test Product B Test Product D Test Product C

Group II: Randomization Sequence 5: EFDACBExperimental Treatment6 Interventions

Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6 day in-clinic period in following order: Reference Product E Reference Product F Test Product D Test Product A Test Product C Test Product B

Group III: Randomization Sequence 4: DECFBAExperimental Treatment6 Interventions

Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6 day in-clinic period in following order: Test Product D Reference Product E Test Product C Reference Product F Test Product B Test Product A

Group IV: Randomization Sequence 3: CDBEAFExperimental Treatment6 Interventions

Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6 day in-clinic period in following order: Test Product C Test Product D Test Product B Reference Product E Test Product A Reference Product F

Group V: Randomization Sequence 2: BCADFEExperimental Treatment6 Interventions

Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6 day in-clinic period in following order: Test Product B Test Product C Test Product A Test Product D Reference Product F Reference Product E

Group VI: Randomization Sequence 1: ABFCEDExperimental Treatment6 Interventions

Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6 day in-clinic period in following order: Test Product A Test Product B Reference Product F Test Product C Reference Product E Test Product D