Adults 21 to 65, any sex, with Tobacco Use. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population)Primary· Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary statistics of percent change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \[NNAL\] (%) in each study visit are presented.
Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the
Visit 4
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
3.8
± 34.11
Control (no VBM-FG2)
13.8
± 45.56
Visit 5
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
12.5
± 60.16
Control (no VBM-FG2)
30.4
± 63.66
Visit 6
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
16.0
± 50.87
Control (no VBM-FG2)
29.2
± 46.70
End of Study/Early Termination
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
15.4
± 62.42
Control (no VBM-FG2)
28.4
± 57.66
Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population)Secondary· Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary statistics of change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \[NNAL\] (ng/g creatinine) in each study visit are presented.
Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Visit 4
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
14.99
± 212.505
Control (no VBM-FG2)
9.47
± 207.308
Visit 5
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
70.90
± 436.326
Control (no VBM-FG2)
76.50
± 310.423
Visit 6
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
66.23
± 303.806
Control (no VBM-FG2)
117.69
± 289.763
End of Study/Early Termination
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
81.33
± 345.110
Control (no VBM-FG2)
86.53
± 209.749
Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population)Secondary· Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary statistics of change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (mg/g creatinine) in each study visit are presented.
Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Visit 4
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-0.6
± 5.28
Control (no VBM-FG2)
0.6
± 6.45
Visit 5
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
1.9
± 8.46
Control (no VBM-FG2)
2.5
± 6.48
Visit 6
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
1.1
± 8.03
Control (no VBM-FG2)
4.3
± 9.47
End of Study/Early Termination
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
2.6
± 9.75
Control (no VBM-FG2)
3.6
± 6.89
Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population)Secondary· Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary statistics of percent change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (%) in each study visit are presented.
Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtract
Visit 4
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
3.2
± 37.85
Control (no VBM-FG2)
14.8
± 51.81
Visit 5
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
18.7
± 57.95
Control (no VBM-FG2)
26.3
± 50.78
Visit 6
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
15.7
± 54.02
Control (no VBM-FG2)
30.8
± 53.08
End of Study/Early Termination
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
25.2
± 65.08
Control (no VBM-FG2)
35.5
± 60.54
Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population)Secondary· Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary statistics of change from Baseline for urinary S-phenyl mercapturic acid \[S-PMA\] (ng/g creatinine) in each study visit are presented.
Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Visit 4
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
506.33
± 3150.049
Control (no VBM-FG2)
242.66
± 2846.817
Visit 5
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
1129.88
± 4867.996
Control (no VBM-FG2)
809.04
± 3649.614
Visit 6
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
1102.42
± 4045.946
Control (no VBM-FG2)
1637.29
± 4348.050
End of Study/Early Termination
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
903.49
± 4985.072
Control (no VBM-FG2)
1160.48
± 2798.644
Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population)Secondary· Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary statistics of percent change from Baseline for urinary S-phenyl mercapturic acid \[S-PMA\] (%) in each study visit are presented.
Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's bas
Visit 4
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
17.5
± 67.39
Control (no VBM-FG2)
21.1
± 77.37
Visit 5
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
13.4
± 67.41
Control (no VBM-FG2)
38.2
± 69.68
Visit 6
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
19.7
± 60.60
Control (no VBM-FG2)
44.4
± 87.87
End of Study/Early Termination
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
20.9
± 76.27
Control (no VBM-FG2)
39.1
± 70.93
Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)Secondary· Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary statistics of change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented.
Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Visit 4
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-0.42
± 1.449
Control (no VBM-FG2)
0.03
± 1.460
Visit 5
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-0.24
± 1.418
Control (no VBM-FG2)
0.39
± 1.374
Visit 6
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-0.02
± 1.547
Control (no VBM-FG2)
0.39
± 1.299
End of Study/Early Termination
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-0.61
± 1.387
Control (no VBM-FG2)
-0.10
± 1.118
Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)Secondary· Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary statistics of percent change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented.
Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and mult
Visit 4
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-6.3
± 27.48
Control (no VBM-FG2)
5.3
± 35.59
Visit 5
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-4.0
± 26.17
Control (no VBM-FG2)
9.8
± 27.21
Visit 6
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
1.4
± 28.26
Control (no VBM-FG2)
11.3
± 29.44
End of Study/Early Termination
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-9.3
± 27.89
Control (no VBM-FG2)
0.7
± 25.53
Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population)Secondary· Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary statistics of change from Baseline for exhaled carbon monoxide (ppm) in each study visit are presented.
Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Visit 4
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-1.4
± 9.41
Control (no VBM-FG2)
-0.2
± 7.84
Visit 5
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-1.9
± 7.48
Control (no VBM-FG2)
0.7
± 8.37
Visit 6
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-0.8
± 9.30
Control (no VBM-FG2)
0.6
± 7.89
End of Study/Early Termination
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-2.3
± 9.17
Control (no VBM-FG2)
-0.8
± 6.90
Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population)Secondary· Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary statistics of percent change from Baseline for exhaled carbon monoxide (%) in each study visit are presented.
Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and mult
Visit 4
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-0.8
± 44.65
Control (no VBM-FG2)
12.0
± 65.86
Visit 5
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-5.8
± 37.05
Control (no VBM-FG2)
11.4
± 54.87
Visit 6
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
3.5
± 49.07
Control (no VBM-FG2)
13.9
± 57.42
End of Study/Early Termination
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-3.1
± 47.00
Control (no VBM-FG2)
9.0
± 66.04
Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population)Secondary· Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary statistics of change from Baseline in number or products used day in each study visit are presented.
Values for visit are the average of daily values for the previous week Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Visit 4
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-2.7
± 3.28
Control (no VBM-FG2)
0.5
± 1.96
Visit 5
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-3.1
± 4.34
Control (no VBM-FG2)
0.3
± 2.37
Visit 6
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-2.9
± 4.41
Control (no VBM-FG2)
0.3
± 2.78
End of Study/Early Termination
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-3.5
± 4.78
Control (no VBM-FG2)
0.4
± 2.76
Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population)Secondary· Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary statistics of percent change from Baseline of number of products used per day in each study visit are presented.
CPD was tracked using an interactive voice response system (IVRS). During the Baseline Period (Days 1 to 8), subjects reported CPD daily through an IVRS each day between 16:00 and 19:00. Test and Control subjects continued daily tobacco use tracking via an IVRS and return to the study site once a week during the 4 week Product Use Period on Days 15, 22, 29, and 36.
Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values
Visit 4
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-15.0
± 19.30
Control (no VBM-FG2)
3.1
± 10.85
Visit 5
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-16.5
± 26.21
Control (no VBM-FG2)
2.9
± 15.18
Visit 6
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-16.3
± 24.78
Control (no VBM-FG2)
2.9
± 18.01
End of Study/Early Termination
Group
Value
95% CI
Test (ad Libitum VBM-FG2)
-19.2
± 27.03
Control (no VBM-FG2)
3.2
± 17.28
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult smokers who continue smoking exclusively.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT07162935 — Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY)
· NA
· recruiting
NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products
· NA
· recruiting
NCT07148232 — Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness
· Phase 4
· recruiting
NCT06983678 — Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chron
· NA
· recruiting
NCT06922617 — STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
· NA
· recruiting
Other Altria Client Services LLC trials
Trials by the same sponsor.
NCT06476405 — Room Air Levels of Harmful and Potentially Harmful Constituents After Heated Tobacco Product Use and Cigarettes
· completed
NCT06356610 — Pharmacokinetic and Subjective Effects of Heated Tobacco Products
· NA
· completed
NCT06179290 — Changes in Biomarker of Exposure in Adults Who Smoke Cigarettes Switching From Cigarettes to Heated Tobacco Products
· NA
· completed
NCT06691386 — Nicotine Pharmacokinetics and Subjective Effects of Oral Nicotine Products Relative to Smokeless Tobacco in Adult Users
· NA
· completed
NCT05664672 — Study to Evaluate Changes in Smokers Using on!® Nicotine Pouches
· NA
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Altria Client Services LLC
Last refreshed: 27 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04079933.