Heated Tobacco Products for Tobacco Use

Recruiting at 2 trial locations

Overseen By Jeffery S Edmiston

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Altria Client Services LLC

Must not be taking: Bronchodilators, Antibiotics, CYP2A6 inhibitors

Disqualifiers: Malignant tumors, Diabetes, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

170 Participants Needed

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.

Inclusion Criteria

Participants must be informed of the nature and risks of the study and voluntarily give written informed consent prior to screening

Negative pregnancy test at screening and Check-in for all female participants

I am using birth control and can have children.

Exclusion Criteria

Unwilling or unlikely to comply with the requirements of the study

My BMI is either above 40 or below 18.

Participant or a first-degree relative is a current or former employee of the tobacco industry or a named party in litigation with a tobacco company

Timeline

Screening

Participants are screened for eligibility to participate in the trial

28 days

1 visit (in-person), 5-day at-home product trial

Enrollment and Acclimation

Participants receive Ploom® HTP products for at-home acclimation and training on device use

5 days

1 visit (in-person)

In-clinic Confinement and Product Use

Participants use assigned products in a controlled environment with PK and subjective effects assessments

6 days

Daily sessions (in-clinic)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Heated Tobacco Products

Trial Overview 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.

Participant Groups

Group I: Randomization Sequence 6: FAEBDC Experimental Treatment 6 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: EFDACB Experimental Treatment 6 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: DECFBA Experimental Treatment 6 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: CDBEAF Experimental Treatment 6 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: BCADFE Experimental Treatment 6 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: ABFCED Experimental Treatment 6 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

Who Is Running the Clinical Trial?

Altria Client Services LLC

Lead Sponsor

Trials

10

Recruited

1,900+

Celerion

Industry Sponsor

Trials

85

Recruited

7,600+

Dr. Susan Thornton

Celerion

Chief Executive Officer since 2010

PhD in Molecular Biology from the University of Pennsylvania

Dr. Lorraine M. Rusch

Celerion

Chief Medical Officer since 2020

MD from an unspecified institution