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Heated Tobacco Product

Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B for Smoking

N/A
Waitlist Available
Research Sponsored by British American Tobacco (Investments) Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This trial will test whether switching to the study's investigational products (IPs) is safer for generally healthy smokers than continuing to smoke, undergoing smoking abstinence, or never having smoked.

Eligible Conditions
  • Smoking
  • Tobacco Use
  • Tobacco Smoking

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
3-hydroxypropyl mercapturic acid (3-HPMA)
Carboxyhemoglobin (COHb)
Monohydroxybutyl mercapturic acid (MHBMA)
+2 more

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 5: Non-combusted cigarette variant 42001402 and product use mode AExperimental Treatment1 Intervention
Subjects randomized to use of a non-combusted cigarette variant and product use mode A
Group II: Cohort 4: Non-combusted cigarette variant 40007386 and product use mode BExperimental Treatment1 Intervention
Subjects randomized to use of a non-combusted cigarette variant and product use mode B
Group III: Cohort 3: Non-combusted cigarette variant 42001401 and product use mode BExperimental Treatment1 Intervention
Subjects randomized to use of a non-combusted cigarette variant and product use mode B
Group IV: Cohort 2: Non-combusted cigarette variant 42001399 and product use mode BExperimental Treatment1 Intervention
Subjects randomized to use of a non-combusted cigarette variant and product use mode B
Group V: Cohort 1: Non-combusted cigarette variant 42001402 and product use mode BExperimental Treatment1 Intervention
Subjects randomized to use of a non-combusted cigarette variant and product use mode B
Group VI: Cohort 6: Usual Brand CigarettesActive Control1 Intervention
Subjects randomized to continue to smoke usual brand cigarettes
Group VII: Cohort 7: Assisted Smoking CessationActive Control1 Intervention
Subjects assigned to assisted smoking cessation
Group VIII: Cohort 8: Never-SmokersActive Control1 Intervention
Never-smokers

Find a Location

Who is running the clinical trial?

British American Tobacco (Investments) LimitedLead Sponsor
6 Previous Clinical Trials
334 Total Patients Enrolled
2 Trials studying Smoking
58 Patients Enrolled for Smoking
CelerionIndustry Sponsor
81 Previous Clinical Trials
7,008 Total Patients Enrolled
3 Trials studying Smoking
156 Patients Enrolled for Smoking
Nathan GaleStudy DirectorBAT

Frequently Asked Questions

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

Does this trial have vacancies for participants?

"According to clinicaltrials.gov, this trial is not at present recruiting patients. Initially posted on January 13th 2022 and last updated December 2nd 2022, no participants are being sought for the study. Nonetheless 138 other medical trials are now taking applicants."

Answered by AI

Who is qualified to partipate in this clinical research experiment?

"To participate in this trial, individuals must meet two criteria: they need to be between the ages of 26 and 55 and have a history of tobacco use. The research team aims to recruit 806 people."

Answered by AI

Are there any geographic limitations to this research initiative?

"Monroe Biomedical Research, Centricity Research and Clinical Trials of Texas are the three major sites for this trial. Additionally, 15 other clinical locations across America have been enlisted to recruit patients."

Answered by AI

Does this trial accept individuals under eighty years of age?

"This clinical trial has established 26 years old as the minimum age for participation, with a maximum of 55."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Arkansas
Indiana
How old are they?
18 - 65
What site did they apply to?
Woodland Research Northwest
Bright Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
BAT3221032: A Study to Evaluate the Effects of Switching From Cigarette Smoking to Using One of Five Variants of a Heated Tobacco Product on Biomarkers of Exposure and Biomarkers of Potential Harm in Healthy Subjects
2022. "BAT3221032: A Study to Evaluate the Effects of Switching From Cigarette Smoking to Using One of Five Variants of a Heated Tobacco Product on Biomarkers of Exposure and Biomarkers of Potential Harm in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05142436.
~248 spots leftby Apr 2025
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