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

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tobacco Use+2 More
Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

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
  • Tobacco Use
  • Tobacco
  • Smoking

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 0 Secondary · Reporting Duration: 180 days

180 days
11-dehydrothromboxane B2 (11-DTX-B2)
8-epi-prostaglandin F2α Type III (8-Epi-PGF2α Type III)
Carboxyhemoglobin (COHb)
Fraction of exhaled nitric oxide (FeNO)
High-density lipoprotein (HDL)
Soluble intercellular adhesion molecule-1 (sICAM-1)
Total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL] + glucuronides)
Total white blood cell count (WBC)
90 days
3-hydroxypropyl mercapturic acid (3-HPMA)
Monohydroxybutyl mercapturic acid (MHBMA)
S-phenyl mercapturic acid (S-PMA)

Trial Safety

Safety Progress

1 of 3

Trial Design

8 Treatment Groups

Cohort 7: Assisted Smoking Cessation
1 of 8
Cohort 8: Never-Smokers
1 of 8
Cohort 6: Usual Brand Cigarettes
1 of 8
Cohort 1: Non-combusted cigarette variant 42001402 and product use mode B
1 of 8
Cohort 2: Non-combusted cigarette variant 42001399 and product use mode B
1 of 8
Cohort 3: Non-combusted cigarette variant 42001401 and product use mode B
1 of 8
Cohort 4: Non-combusted cigarette variant 40007386 and product use mode B
1 of 8
Cohort 5: Non-combusted cigarette variant 42001402 and product use mode A
1 of 8

Active Control

Experimental Treatment

1885 Total Participants · 8 Treatment Groups

Primary Treatment: Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B · No Placebo Group · N/A

Cohort 1: Non-combusted cigarette variant 42001402 and product use mode B
Other
Experimental Group · 1 Intervention: Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode B · Intervention Types: Other
Cohort 2: Non-combusted cigarette variant 42001399 and product use mode B
Other
Experimental Group · 1 Intervention: Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B · Intervention Types: Other
Cohort 3: Non-combusted cigarette variant 42001401 and product use mode B
Other
Experimental Group · 1 Intervention: Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode B · Intervention Types: Other
Cohort 4: Non-combusted cigarette variant 40007386 and product use mode B
Other
Experimental Group · 1 Intervention: Product D: Non-Combusted Cigarette Variant 40007386 and product use Mode B · Intervention Types: Other
Cohort 5: Non-combusted cigarette variant 42001402 and product use mode A
Other
Experimental Group · 1 Intervention: Product E: Non-Combusted Cigarette Variant 42001402 and product use Mode A · Intervention Types: Other
Cohort 7: Assisted Smoking CessationNoIntervention Group · 1 Intervention: Cohort 7: Assisted Smoking Cessation · Intervention Types:
Cohort 8: Never-SmokersNoIntervention Group · 1 Intervention: Cohort 8: Never-Smokers · Intervention Types:
Cohort 6: Usual Brand CigarettesNoIntervention Group · 1 Intervention: Cohort 6: Usual Brand Cigarettes · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 180 days

Who is running the clinical trial?

CelerionIndustry Sponsor
77 Previous Clinical Trials
6,612 Total Patients Enrolled
5 Trials studying Tobacco Use
424 Patients Enrolled for Tobacco Use
British American Tobacco (Investments) LimitedLead Sponsor
5 Previous Clinical Trials
156 Total Patients Enrolled
2 Trials studying Tobacco Use
72 Patients Enrolled for Tobacco Use
Nathan GaleStudy DirectorBAT

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are female and you are willing to use a form of contraception acceptable to the PI from the time of informed consent until the end of the study.
You are generally healthy and of a certain age.
You agree to abide by the study restrictions and requirements, including use of the assigned product or to undergo smoking cessation, and agree to in-clinic, overnight confinement at Visits 1, 4 and 7.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: November 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Florida33.3%
Arkansas33.3%
Indiana33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Woodland Research Northwest50.0%
Bright Research Center50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%