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Heated Tobacco Products for Tobacco Use

N/A
Recruiting
Research Sponsored by Altria Client Services LLC
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 day 1 through day 6
Awards & highlights

Summary

This trial will test the nicotine levels and effects of different Heated Tobacco Products on adult smokers. Participants will try two menthol and two tobacco flavored HTPs, along with their usual brand of cigarettes

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed for this trial, common side effects from using nicotine products can include nausea, headache, increased heart rate/blood pressure, dizziness, throat/mouth irritation, and potential addiction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Direct Effects of Product Questionnaire
Modified Cigarette Evaluation Questionnaire (mCEQ) - Cigarette
Modified Cigarette Evaluation Questionnaire - HTP
+13 more

Trial Design

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

Find a Location

Who is running the clinical trial?

CelerionIndustry Sponsor
81 Previous Clinical Trials
7,754 Total Patients Enrolled
7 Trials studying Tobacco Use
1,530 Patients Enrolled for Tobacco Use
Altria Client Services LLCLead Sponsor
8 Previous Clinical Trials
1,746 Total Patients Enrolled
7 Trials studying Tobacco Use
1,346 Patients Enrolled for Tobacco Use
~38 spots leftby Sep 2025