Changes in Biomarker of Exposure in Adults Who Smoke Ciga... | NCT06179290 | Trialant
NCT06179290
Sponsor
Altria Client Services LLC
Status
Completed
Last Update Posted
May 27, 2026Actual
Enrollment
921Actual
Phase
Not Applicable
Conditions
Tobacco Use
Interventions
Ploom HTP Menthol HTS; MX3 (681)
Ploom HTP Tobacco HTS; R8 (120)
Smoking Abstinence (menthol)
Smoking Abstinence (non-menthol)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT06179290
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ALCS-REG-23-07-HT
Secondary IDs
Not provided
Brief Title
Changes in Biomarker of Exposure in Adults Who Smoke Cigarettes Switching From Cigarettes to Heated Tobacco Products
Official Title
A Multi-site, Open-Label, Parallel-Group Study To Evaluate Changes In Tobacco-Related Biomarkers of Exposure and Biomarkers of Potential Harm With Use of Heated Tobacco Products Compared to Combustible Cigarettes in Adult Smokers
Acronym
Not provided
Organization
Altria Client Services LLCINDUSTRY
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2, 2023Actual
Primary Completion Date
May 15, 2024Actual
Completion Date
Mar 24, 2025Actual
First Submitted Date
Dec 12, 2023
First Submission Date that Met QC Criteria
Dec 12, 2023
First Posted Date
Dec 21, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Nov 4, 2025
Results First Submitted that Met QC Criteria
May 1, 2026
Results First Posted Date
May 27, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 1, 2026
Last Update Posted Date
May 27, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Altria Client Services LLCINDUSTRY
Collaborators
Name
Class
Celerion
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study is to evaluate changes in biomarkers of exposure (BoE) to harmful and potentially harmful constituents (HPHCs) in adult smokers who completely switch to Ploom heated tobacco products (HTPs) compared to those who continue to smoke usual brand combustible cigarettes (UBCC).
Detailed Description
This is a multi-site, open-label, two-group (menthol and non-menthol), six-arm (HTP, Continue Smoking, and Smoking Abstinence arms within each group) randomized, clinical study to evaluate changes in BoEs in adult smokers who remain smoking, switch to the Ploom HTP, or abstain from smoking, for 60 days (5 days in clinic followed by a 55-day ambulatory phase). Target enrollment is 300 male and female adult smokers between the ages of 22 and 65 in overall good health.
Conditions Module
Conditions
Tobacco Use
Keywords
Tobacco
Smoking
Heated tobacco
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
921Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Study Product A: Ploom HTP Menthol HTS; MX3 (681)
Experimental
Subjects in A arm (Group 1 Menthol) will be required to smoke Ploom HTP Menthol HTS; MX3 (681) study product at least 5 times per day ad libitum from 07:00 through 23:00. There will be 60 subjects assigned to this arm with a randomization ratio of 2.
Other: Ploom HTP Menthol HTS; MX3 (681)
Study Product B: Continue Smoking (menthol)
No Intervention
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from 07:00 through 23:00. There will be 60 subjects assigned to this arm with a randomization ratio of 2.
Study Product C: Smoking Abstinence (menthol)
Active Comparator
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases. There will be 30 subjects assigned to this arm with a randomization ratio of 1.
Other: Smoking Abstinence (menthol)
Study Product D: Ploom HTP Tobacco HTS; R8 (120)
Experimental
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS; R8 (120) study product at least 5 times per day ad libitum from 07:00 through 23:00. There will be 60 subjects assigned to this arm with a randomization ratio of 2.
Other: Ploom HTP Tobacco HTS; R8 (120)
Study Product E: Continue Smoking (non-menthol)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ploom HTP Menthol HTS; MX3 (681)
Other
Menthol heated tobacco product
Study Product A: Ploom HTP Menthol HTS; MX3 (681)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in urine adjusted for urine creatinine (pg/mg creatinine)
Baseline through Day 5
Total N-nitrosonornicotine (NNN)
Total N-nitrosonornicotine (NNN) in urine adjusted for urine creatinine (pg/mg creatinine)
Baseline through Day 5
2-hydroxybutenylmercapturic Acid (2-MHBMA)
2-hydroxybutenylmercapturic acid (2-MHBMA) in urine adjusted for urine creatinine (ng/mg creatinine)
Baseline through Day 5
3-hydroxypropylmercapturic Acid (3-HPMA)
3-hydroxypropylmercapturic acid (3-HPMA) in urine adjusted for urine creatinine (ng/mg creatinine)
Baseline through Day 5
S-phenyl Mercapturic Acid (SPMA)
S-phenyl mercapturic acid (SPMA) in urine adjusted for urine creatinine (pg/mg creatinine)
Baseline through Day 5
2-Hydroxyethyl Mercapturic Acid (HEMA)
2-Hydroxyethyl mercapturic acid (HEMA) in urine adjusted for urine creatinine (ng/mg creatinine)
Baseline through Day 5
1-aminonaphthalene (1-AN)
1-aminonaphthalene (1-AN) in urine adjusted for urine creatinine (pg/mg creatinine)
Baseline through Day 5
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Voluntary consent to participate in this study documented on the signed ICF.
Score 5 or higher (moderate dependence or higher) on the FTCD.
Healthy adult males and females ≥ 22 and ≤ 65 years of age, inclusive, at Screening.
Smoking history (self-reported at screening) of an average of at least 10 but no more than 30 factory-manufactured combustible cigarettes (either menthol or non-menthol) daily for at least 12 months prior to screening. Brief periods (ie, up to 7 consecutive days) of non-smoking during the 3 months prior to screening (eg, due to illness or participation in a study where smoking was prohibited) will be permitted.
Screening and first check-in blood pressure ≤ 150/90 mmHg measured after being seated for at least 10 minutes. Two rechecks may be performed at the Principal Investigator's discretion.
Positive urine cotinine (≥ 500 ng/mL) at screening.
Exhaled carbon monoxide (eCO) ≥ 10 ppm at screening.
Post-bronchodilator forced expired volume in 1 second (FEV1) : forced vital capacity (FVC) ratio > 0.7 and FEV1 > 80% of predicted at screening.
Negative pregnancy test at Screening and first check-in (Day -2) for all female subjects.
Female subjects who are heterosexually active and of childbearing potential (eg, neither surgically sterile at least 6 months prior to first check-in nor postmenopausal with amenorrhea for at least 12 months prior to first check-in with follicle-stimulating hormone [FSH] levels consistent with postmenopausal status) must have been using one of the following forms of contraception for the time period indicated and agree to continue using it through completion of the study:
hormonal (eg, oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to first check-in, when used in combination with male condoms with spermicide (use of NuvaRing® is at the Principal Investigator's discretion)
double barrier (eg, condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to first check-in
intrauterine device or system (utilize Principal Investigator discretion regarding use of hormonal or nonhormonal devices) for at least 3 months prior to first check-in
exclusive partner who is clinically sterile (ie, documented infertility or surgical sterilization; see below for additional information on sterility) or has been vasectomized for at least 6 months (inclusive) prior to first check-in Note: Sexual abstinence, defined as refraining from intercourse, is allowed when this is in line with the preferred and usual lifestyle of the subject. Female subjects of childbearing potential who are not currently engaging in heterosexual intercourse must agree to use one of the above methods of birth control through completion of study, in the event that they have heterosexual intercourse during the course of the study.
Female subjects who are of nonchildbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to first check-in:
Hysteroscopic sterilization (including Essure® or similar nonsurgical sterilization procedures);
bilateral tubal ligation or bilateral salpingectomy;
hysterectomy;
bilateral oophorectomy Or be postmenopausal with amenorrhea for at least 12 months prior to first check-in and have FSH levels consistent with postmenopausal status.
Willing to comply with the requirements of the study.
Willing to use Ploom HTP after the Product Trial at first check-in.
Willing and able to abstain from cigarettes from Day 1 through the end of the study (EOS) on Day 60 (±3 days) if they are randomized to a Smoking Abstinence arm.
Exclusion Criteria:
Use of any type of tobacco- or nicotine-containing products other than manufactured cigarettes (eg, e-vapor products, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) in the 7 days prior to first check-in.
Self-reported puffers (ie, adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
Planning to quit smoking in the next three months (at screening).
History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, existing respiratory diseases, immunologic, psychiatric, lymphatic, or cardiovascular disease, or any other condition that, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
Clinically significant abnormal findings on the vital signs, physical examination, medical history, ECG, or clinical laboratory results, in the opinion of the Principal Investigator.
Positive test for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at screening.
History or presence of any type of malignant tumors.
Current evidence or any history of congestive heart failure.
Diabetes mellitus (fasting glucose ≥126 mg/L [7 mmol/L]) that is not controlled by diet/exercise alone, in the opinion of the Principal Investigator.
An acute illness (eg, upper respiratory infection, viral infection) requiring treatment with prescribed medicines within 2 weeks prior to first check-in.
Any planned surgery from the time of screening through EOS.
History of drug or alcohol abuse within 24 months prior to first check-in.
Fever (ie, body temperature >100.5°F) at screening or first check-in. One re-check may be performed at the Principal Investigator's discretion.
Body mass index greater than 40.0 kg/m2 or less than 18.0 kg/m2 at screening.
Systolic blood pressure >150 mmHg and/or diastolic blood pressure > 90 mmHg at screening or first check-in, measured after being seated for at least 10 minutes. Two re-checks may be performed at the Principal Investigator's discretion.
Serum alanine aminotransferase ≥1.5 times the upper limit of normal and/or aspartate aminotransferase ≥1.5 times the upper limit of normal at screening.
Positive screen for alcohol (urine/breath) or any of the following drugs of abuse (urine/saliva), regardless of the reason of use: amphetamines, methamphetamines, opiates, cannabinoids, or cocaine at screening or first check-in.
Female subjects who are pregnant (positive serum pregnancy test at screening or urine/serum pregnancy test at first check-in), lactating, or intend to become pregnant from screening through EOS.
Use of prescription or over-the-counter bronchodilator medication (eg, inhaled or oral ß-agonists) for treatment of any illnesses and within 12 months prior to first check-in and throughout the study.
Use of medications or foods known or are suspected to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, clofibrate, clotrimazole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, grapefruit, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, secobarbital, selegiline, sulconazole, tioconazole, tranylcypromine) within 14 days or 5 half-lives of the drug, whichever is longer, prior to first check-in or during the study.
Use of antibiotic treatment within 2 weeks prior to first check-in.
Plasma donation within 7 days prior to first check-in.
Donation of blood or blood products (with the exception of plasma as noted above), had significant blood loss, or received whole blood or a blood product transfusion within 56 days prior to first check-in.
Participation in a previous clinical study for an investigational drug, device, biologic, or a tobacco product within 30 days prior to first check-in.
Subject or a first-degree relative (ie, parent, sibling, child, spouse/partner) is a current or former employee of the tobacco industry or a named party or class representative in litigation with any tobacco company.
Subject or a first-degree relative (ie, parent, sibling, child, spouse/partner) is a current employee of the study site.
Have been diagnosed with major depressive disorder or have a history of suicide attempt.
Have pre-bronchodilator to post-bronchodilator FEV1 increases of greater than or equal to 12% or grade "C" or worse per ATS/ERS 2019 standards.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
22 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pillar Clinical Research
Bentonville
Arkansas
72712
United States
Woodland Research Northwest
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 921 subjects consented to study participation; 611 subjects failed screening testing: 4 subjects met eligibility criteria but were not needed; 306 participants enrolled in the Product Trial period and 10 participants discontinued study participation either due to failure to meet randomization criteria or withdrawal by subject prior to study randomization on Day -1, resulting in 296 participants randomized into study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
This is a multi-site, open-label, two-group (menthol and non-menthol), six-arm (HTP, Continue Smoking, and Smoking Abstinence arms within each group) randomized, clinical study to evaluate changes in BoEs in adult smokers who remain smoking, switch to the Ploom HTP, or abstain from smoking, for 60 days (5 days in clinic followed by 55-day ambulatory phase). This study follows the recommendations of the FDA's final Premarket Tobacco Product Application guidance (FDA, 2023).
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
No Intervention
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from 07:00 through 23:00. There will be 60 subjects assigned to this arm with a randomization ratio of 2.
Study Product F: Smoking Abstinence (non-menthol)
Active Comparator
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases. There will be 30 subjects assigned to this arm with a randomization ratio of 1.
Other: Smoking Abstinence (non-menthol)
Ploom HTP Tobacco HTS; R8 (120)
Other
Non-menthol heated tobacco product
Study Product D: Ploom HTP Tobacco HTS; R8 (120)
Smoking Abstinence (menthol)
Other
No smoking or other tobacco product use for duration of the study, menthol group comparator
Study Product C: Smoking Abstinence (menthol)
Smoking Abstinence (non-menthol)
Other
No smoking or other tobacco product use for duration of the study, non-menthol group comparator
Study Product F: Smoking Abstinence (non-menthol)
2-aminonaphthalene (2-AN)
2-aminonaphthalene (2-AN) in urine adjusted for urine creatinine (pg/mg creatinine)
Baseline through Day 5
2-cyanoethyl-mercapturic Acid (CEMA)
2-cyanoethyl-mercapturic acid (CEMA) in urine adjusted for urine creatinine (ng/mg creatinine)
Baseline to Day 5
3-hydroxybenzo[a]Pyrene (3-OH-B[a]P)
3-hydroxybenzo[a]pyrene (3-OH-B[a]P) in urine adjusted for urine creatinine (fg/mg creatinine)
Baseline through Day 5
3-hydroxy-1-methylpropylmercapturic Acid (HMPMA)
3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine adjusted for urine creatinine (ng/mg creatinine)
Baseline through Day 5
4-Aminobiphenyl (4-ABP)
4-Aminobiphenyl (4-ABP) in urine adjusted for urine creatinine (pg/mg creatinine)
Baseline through Day 5
S-benzyl Mercapturic Acid (SBMA)
S-benzyl mercapturic acid (SBMA) in urine adjusted for urine creatinine (pg/mg creatinine)
Baseline through Day 5
Carboxyhemoglobin (COHb)
COHb, or carboxyhemoglobin, is the percent of hemoglobin that is bound to carbon monoxide instead of oxygen
Baseline to Day 5
Rogers
Arkansas
72758
United States
Dr. Vince Clinical Research, LLC
Overland Park
Kansas
66212
United States
Alliance for Multispecialty Research, LLC
Lexington
Kentucky
40509
United States
QPS Bio-Kinetic
Springfield
Missouri
65802
United States
Celerion Lincoln
Lincoln
Nebraska
68502
United States
Alliance for Multispecialty Research, LLC
Knoxville
Tennessee
37920
United States
Spaulding Clinical Research
West Bend
Wisconsin
53095
United States
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
FG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator
FG003
Study Product D: Ploom HTP Tobacco HTS
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
FG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
FG00059 subjects
FG00160 subjects
FG00230 subjects
FG00361 subjects
FG00457 subjects
FG00529 subjects
COMPLETED
FG00043 subjects
FG00151 subjects
FG00216 subjects
FG00348 subjects
FG00452 subjects
FG00517 subjects
NOT COMPLETED
FG00016 subjects
FG0019 subjects
FG00214 subjects
FG00313 subjects
FG0045 subjects
FG00512 subjects
MITT Population
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
BG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator
BG003
Study Product D: Ploom HTP Tobacco HTS
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
BG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00055
BG00155
BG00225
BG00357
BG00454
BG00521
BG006267
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00037.1± 9.03
BG00136.8± 8.05
BG00238.6± 8.37
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00022
BG00122
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Weight (kg)
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00082.55± 15.685
BG00184.85± 19.842
BG002
Height (cm)
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000170.96± 9.166
BG001173.91± 10.484
BG002
BMI (kg/m^2)
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00028.284± 5.0665
BG00128.039± 5.8573
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in urine adjusted for urine creatinine (pg/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
pg/mg creatinine
Baseline through Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG003
Title
Denominators
Categories
Day -1
Title
Measurements
OG000170.800± 124.8543
OG001174.464± 185.1288
OG002194.995± 141.7563
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine NNAL Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG000
OG002
Statistical Comparisons of Urine NNAL Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Primary
Total N-nitrosonornicotine (NNN)
Total N-nitrosonornicotine (NNN) in urine adjusted for urine creatinine (pg/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
pg/mg creatinine
Baseline through Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Primary
2-hydroxybutenylmercapturic Acid (2-MHBMA)
2-hydroxybutenylmercapturic acid (2-MHBMA) in urine adjusted for urine creatinine (ng/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
ng/mg creatinine
Baseline through Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Primary
3-hydroxypropylmercapturic Acid (3-HPMA)
3-hydroxypropylmercapturic acid (3-HPMA) in urine adjusted for urine creatinine (ng/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
ng/mg creatinine
Baseline through Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Primary
S-phenyl Mercapturic Acid (SPMA)
S-phenyl mercapturic acid (SPMA) in urine adjusted for urine creatinine (pg/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
pg/mg creatinine
Baseline through Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Primary
2-Hydroxyethyl Mercapturic Acid (HEMA)
2-Hydroxyethyl mercapturic acid (HEMA) in urine adjusted for urine creatinine (ng/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
ng/mg creatinine
Baseline through Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Primary
1-aminonaphthalene (1-AN)
1-aminonaphthalene (1-AN) in urine adjusted for urine creatinine (pg/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
pg/mg creatinine
Baseline through Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Primary
2-aminonaphthalene (2-AN)
2-aminonaphthalene (2-AN) in urine adjusted for urine creatinine (pg/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
pg/mg creatinine
Baseline through Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Primary
2-cyanoethyl-mercapturic Acid (CEMA)
2-cyanoethyl-mercapturic acid (CEMA) in urine adjusted for urine creatinine (ng/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
ng/mg creatinine
Baseline to Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Primary
3-hydroxybenzo[a]Pyrene (3-OH-B[a]P)
3-hydroxybenzo[a]pyrene (3-OH-B[a]P) in urine adjusted for urine creatinine (fg/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
fg/mg creatinine
Baseline through Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Primary
3-hydroxy-1-methylpropylmercapturic Acid (HMPMA)
3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine adjusted for urine creatinine (ng/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
ng/mg creatinine
Baseline through Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Primary
4-Aminobiphenyl (4-ABP)
4-Aminobiphenyl (4-ABP) in urine adjusted for urine creatinine (pg/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
pg/mg creatinine
Baseline through Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Primary
S-benzyl Mercapturic Acid (SBMA)
S-benzyl mercapturic acid (SBMA) in urine adjusted for urine creatinine (pg/mg creatinine)
MITT Population
Posted
Mean
Standard Deviation
pg/mg creatinine
Baseline through Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Primary
Carboxyhemoglobin (COHb)
COHb, or carboxyhemoglobin, is the percent of hemoglobin that is bound to carbon monoxide instead of oxygen
MITT Population
Posted
Mean
Standard Deviation
COHb (%)
Baseline to Day 5
ID
Title
Description
OG000
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
OG002
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
OG003
Study Product D: Ploom HTP Tobacco HTS
Time Frame
From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Product Trial Period
Product trial include the adverse events occurred during the product trial and baseline period.
0
306
0
306
31
306
EG001
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
0
60
1
60
10
60
EG003
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
1
30
1
30
3
30
EG004
Study Product D: Ploom HTP Tobacco HTS
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Statistical Comparisons of Urine NNAL Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG003
OG005
Statistical Comparisons of Urine NNAL Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.9801
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG00357
OG00454
OG00521
Title
Denominators
Categories
Day -1
Title
Measurements
OG00012.040± 53.3206
OG0018.775± 32.5520
OG0025.444± 5.3881
OG00326.947± 104.5354
OG0048.572± 6.8520
OG00511.192± 13.8495
Day 5
Title
Measurements
OG0001.375± 1.3337
OG0014.859± 4.0353
OG0020.180± 0.2838
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine NNN Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG000
OG002
Statistical Comparisons of Urine NNN Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.0593
Superiority
OG003
OG004
Statistical Comparisons of Urine NNN Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG003
OG005
Statistical Comparisons of Urine NNN Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.5200
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG00357
OG00454
OG00521
Title
Denominators
Categories
Day -1
Title
Measurements
OG0002.137± 1.6120
OG0011.847± 1.4816
OG0022.162± 1.6899
OG0032.210± 1.5263
OG0043.033± 2.1493
OG0052.949± 2.1748
Day 5
Title
Measurements
OG0000.111± 0.0564
OG0011.908± 1.6431
OG0020.125± 0.0794
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine 2-MHBMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG000
OG002
Statistical Comparisons of Urine 2-MHBMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
0.9978
Superiority
OG003
OG004
Statistical Comparisons of Urine 2-MHBMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG003
OG005
Statistical Comparisons of Urine 2-MHBMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
0.1561
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG00357
OG00454
OG00521
Title
Denominators
Categories
Day -1
Title
Measurements
OG000829.767± 367.8057
OG001834.225± 484.5765
OG002850.262± 428.0811
OG003948.776± 413.4578
OG0041042.730± 456.3864
OG0051004.666± 528.2803
Day 5
Title
Measurements
OG000253.882± 95.9616
OG001833.978± 454.5715
OG002227.284± 71.2002
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine 3-HPMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG000
OG002
Statistical Comparisons of Urine 3-HPMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
0.4951
Superiority
OG003
OG004
Statistical Comparisons of Urine 3-HPMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG003
OG005
Statistical Comparisons of Urine 3-HPMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
0.2308
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG00357
OG00454
OG00521
Title
Denominators
Categories
Day -1
Title
Measurements
OG0003510.177± 2547.2148
OG0013112.358± 2587.9965
OG0023716.221± 3118.0196
OG0033323.300± 2249.6061
OG0044789.832± 3281.2831
OG0054477.719± 3215.3437
Day 5
Title
Measurements
OG000254.116± 202.1143
OG0013070.205± 2628.8427
OG002360.856± 354.5053
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine SPMA Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG000
OG002
Statistical Comparisons of Urine SPMA Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.9334
Superiority
OG003
OG004
Statistical Comparisons of Urine SPMA Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG003
OG005
Mixed Models Analysis
0.1902
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG00357
OG00454
OG00521
Title
Denominators
Categories
Day -1
Title
Measurements
OG0003.868± 4.0284
OG0013.604± 3.5749
OG0023.863± 3.0593
OG0034.127± 3.4968
OG0044.908± 4.4893
OG0054.436± 5.6017
Day 5
Title
Measurements
OG0001.207± 1.0405
OG0013.362± 2.8263
OG0020.983± 0.5246
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine HEMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG000
OG002
Statistical Comparisons of Urine HEMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
0.3472
Superiority
OG003
OG004
Statistical Comparisons of Urine HEMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG003
OG005
Statistical Comparisons of Urine HEMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
0.6567
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG00357
OG00454
OG00521
Title
Denominators
Categories
Day -1
Title
Measurements
OG00078.519± 36.3020
OG00171.920± 41.9082
OG00277.334± 43.0510
OG00399.217± 54.1058
OG004105.310± 43.1709
OG005101.899± 48.4057
Day 5
Title
Measurements
OG0004.901± 9.5656
OG00171.968± 46.0026
OG0024.186± 3.2778
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine 1-AN Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG000
OG002
Statistical Comparisons of Urine 1-AN Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.9687
Superiority
OG003
OG004
Statistical Comparisons of Urine 1-AN Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG003
OG005
Statistical Comparisons of Urine 1-AN Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.5154
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG00357
OG00454
OG00521
Title
Denominators
Categories
Day -1
Title
Measurements
OG00024.369± 11.3051
OG00121.931± 12.1576
OG00224.919± 13.9308
OG00329.671± 14.5973
OG00432.192± 13.6806
OG00532.803± 17.9562
Day 5
Title
Measurements
OG0002.919± 1.5628
OG00121.818± 12.9678
OG0022.969± 1.8499
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine 2-AN Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG000
OG002
Statistical Comparisons of Urine 2-AN Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.9174
Superiority
OG003
OG004
Statistical Comparisons of Urine 2-AN Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG003
OG005
Statistical Comparisons of Urine 2-AN Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.3939
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG00357
OG00454
OG00521
Title
Denominators
Categories
Day -1
Title
Measurements
OG000104.903± 44.7835
OG00195.215± 51.4508
OG002111.016± 57.2097
OG003119.283± 51.9319
OG004122.633± 46.2446
OG005130.474± 64.7667
Day 5
Title
Measurements
OG00018.250± 12.9136
OG00193.373± 50.0179
OG00216.838± 13.4913
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine CEMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG000
OG002
Statistical Comparisons of Urine CEMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
0.5098
Superiority
OG003
OG004
Statistical Comparisons of Urine CEMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG003
OG005
Statistical Comparisons of Urine CEMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
0.6813
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG00357
OG00454
OG00521
Title
Denominators
Categories
Day -1
Title
Measurements
OG000164.805± 102.9737
OG001193.878± 171.4818
OG002162.947± 110.8604
OG003206.696± 107.578
OG004230.243± 145.2773
OG005251.885± 199.3621
Day 5
Title
Measurements
OG00029.136± 22.9703
OG001170.848± 126.0485
OG00230.050± 24.1808
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine 3-OH-B[a]P Adjusted for Urine Creatinine (fg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG000
OG002
Statistical Comparisons of Urine 3-OH-B[a]P Adjusted for Urine Creatinine (fg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.9940
Superiority
OG003
OG004
Statistical Comparisons of Urine 3-OH-B[a]P Adjusted for Urine Creatinine (fg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG003
OG005
Statistical Comparisons of Urine 3-OH-B[a]P Adjusted for Urine Creatinine (fg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.1635
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG00357
OG00454
OG00521
Title
Denominators
Categories
Day -1
Title
Measurements
OG000254.165± 114.4959
OG001235.118± 125.9136
OG002242.750± 120.5295
OG003305.876± 140.5156
OG004304.849± 104.1312
OG005352.194± 162.5002
Day 5
Title
Measurements
OG00055.055± 16.1886
OG001232.767± 112.4148
OG00252.376± 23.2316
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine HMPMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG000
OG002
Statistical Comparisons of Urine HMPMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
0.9645
Superiority
OG003
OG004
Statistical Comparisons of Urine HMPMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG003
OG005
Statistical Comparisons of Urine HMPMA Adjusted for Urine Creatinine (ng/mg creatinine) Change From Baseline
Mixed Models Analysis
0.3635
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG00357
OG00454
OG00521
Title
Denominators
Categories
Day -1
Title
Measurements
OG00011.961± 5.5104
OG00111.140± 6.3710
OG00212.082± 7.0283
OG00314.608± 6.7839
OG00416.568± 7.0169
OG00515.952± 9.8441
Day 5
Title
Measurements
OG0002.155± 1.2191
OG00110.811± 6.1092
OG0022.413± 1.6717
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine 4-ABP Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG000
OG002
Statistical Comparisons of Urine 4-ABP Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.8841
Superiority
OG003
OG004
Statistical Comparisons of Urine 4-ABP Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<.0001
Superiority
OG003
OG005
Statistical Comparisons of Urine 4-ABP Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.3387
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
OG005
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
Units
Counts
Participants
OG00055
OG00155
OG00225
OG00357
OG00454
OG00521
Title
Denominators
Categories
Day -1
Title
Measurements
OG0006048.160± 3652.4749
OG0019317.557± 17338.4643
OG0025701.074± 2971.8769
OG0035258.557± 3226.6231
OG0046679.521± 13955.4008
OG0055314.347± 3407.1637
Day 5
Title
Measurements
OG0005137.334± 3038.4035
OG0018912.017± 15988.9106
OG0025275.686± 2260.4106
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistical Comparisons of Urine SBMA Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
<0.2284
Superiority
OG000
OG002
Statistical Comparisons of Urine SBMA Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.7839
Superiority
OG003
OG004
Statistical Comparisons of Urine SBMA Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.3165
Superiority
OG003
OG005
Statistical Comparisons of Urine SBMA Adjusted for Urine Creatinine (pg/mg creatinine) Change From Baseline
Mixed Models Analysis
0.2987
Superiority
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.