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Randomization Sequence 2: BCADFE 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 6

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Do I qualify?Apply below to find out

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

7 Previous Clinical Trials

1,698 Total Patients Enrolled

6 Trials studying Tobacco Use

1,298 Patients Enrolled for Tobacco Use

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently seeking participants for this ongoing medical study?

"Indeed, information provided on clinicaltrials.gov reveals that this particular medical investigation is in the process of seeking suitable individuals. This study was initially made public on February 6th, 2024 and has been recently revised as of April 4th, 2024. The aim is to recruit a total of 60 participants from three distinct locations."

Answered by AI