N/A
N=231
A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.
Tobacco Use
Bottom Line
View on ClinicalTrials.gov: NCT03692078 ↗Enrolled (actual)
231
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) — 511.889; 581.676; 548.751; 638.849 ng/24 hour — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OTDN product 1 (Other); OTDN product 2 (Other); Tobacco Cessation (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Altria Client Services LLC
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) |
511.889; 581.676; 548.751; 638.849; 599.162; 527.260 | <.0001 sig |
| PRIMARY Summary of Urine Total NNAL Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
-4.241; -31.755; -26.092; -66.540; -61.140; -67.092 | — |
| SECONDARY Summary of NNN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) |
17.153; 25.737; 20.254; 37.567; 21.096; 20.271 | <.0001 sig |
| SECONDARY Summary of NNN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
17.679; -39.207; -29.116; -90.367; -79.576; -89.967 | — |
| SECONDARY Summary of Nicotine Equivalents Amount Excreted and Absolute Change From Baseline (mg/24 Hour) by Study Group and Study Day (mITT Population) |
16.887; 17.497; 17.904; 15.991; 15.752; 16.279 | <.0001 sig |
| SECONDARY Summary of Nicotine Equivalents Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
-1.783; -25.070; -13.053; -67.749; -45.240; -95.808 | — |
| SECONDARY Summary of 2-AN Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) |
35.058; 38.438; 39.133; 36.900; 35.420; 39.841 | <.0001 sig |
| SECONDARY Summary of 2-AN Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
-0.214; -41.725; -29.316; -90.186; -93.792; -93.291 | — |
| SECONDARY Summary of 4-ABP Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) |
23.544; 27.465; 26.519; 25.848; 24.833; 26.229 | <.0001 sig |
| SECONDARY Summary of 4-ABP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
-7.609; -40.399; -34.438; -83.203; -84.690; -84.782 | — |
| SECONDARY Summary of HEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
13.637; 17.845; 15.730; 17.668; 20.015; 17.608 | <.0001 sig |
| SECONDARY Summary of HEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
-9.584; -22.916; -21.244; -39.163; -37.608; -48.200 | — |
| SECONDARY Summary of CEMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
252.743; 262.505; 283.673; 265.581; 255.488; 255.411 | <.0001 sig |
| SECONDARY Summary of CEMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
-1.763; -39.043; -37.945; -85.459; -85.106; -84.942 | — |
| SECONDARY Summary of S-PMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
6.961; 8.075; 9.077; 8.540; 6.542; 6.756 | <.0001 sig |
| SECONDARY Summary of S-PMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
0.414; -39.223; -32.680; -92.361; -92.666; -89.785 | — |
| SECONDARY Summary of 3-HMPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
550.337; 566.207; 620.251; 606.423; 569.736; 563.298 | <.0001 sig |
| SECONDARY Summary of 3-HMPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
-5.743; -35.546; -32.157; -68.831; -72.980; -73.991 | — |
| SECONDARY Summary of 3-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
1743.226; 1766.765; 1986.391; 1865.738; 1811.893; 1922.765 | <.0001 sig |
| SECONDARY Summary of 3-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
-1.420; -39.382; -37.881; -75.303; -74.412; -74.897 | — |
| SECONDARY Summary of 2-HPMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
105.297; 110.378; 113.258; 116.041; 108.420; 115.231 | <.0001 sig |
| SECONDARY Summary of 2-HPMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
2.576; -30.260; -28.992; -73.489; -59.835; -75.225 | — |
| SECONDARY Summary of AAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
205.752; 213.840; 234.379; 179.355; 203.156; 212.299 | <.0001 sig |
| SECONDARY Summary of AAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
2.922; -20.973; -11.986; -43.579; -53.493; -51.247 | — |
| SECONDARY Summary of GAMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
28.151; 30.337; 30.415; 25.403; 26.270; 30.737 | <.0001 sig |
| SECONDARY Summary of GAMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
2.015; -16.449; -9.361; -34.427; -39.251; -40.803 | — |
| SECONDARY Summary of 2-MHBMA Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
5.230; 6.226; 7.136; 5.866; 4.146; 5.136 | <.0001 sig |
| SECONDARY Summary of 2-MHBMA Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
89.466; 39.458; -3.704; -82.576; -66.761; -50.591 | — |
| SECONDARY Summary of 2-OHFLe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
6.013; 6.453; 4.947; 5.424; 8.101; 4.852 | <.0001 sig |
| SECONDARY Summary of 2-OHFLe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
12.958; 5043.768; 178.037; -45.034; -37.094; -52.455 | — |
| SECONDARY Summary of 2-Naphthol Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
26.351; 28.168; 28.246; 27.688; 26.292; 24.827 | <.0001 sig |
| SECONDARY Summary of 2-Naphthol Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
-2.871; -42.250; -35.217; -72.375; -74.880; -72.152 | — |
| SECONDARY Summary of 1-OHPhe Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
0.291; 0.325; 0.324; 0.342; 0.273; 0.348 | <.0001 sig |
| SECONDARY Summary of 1-OHPhe Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
-2.014; -30.659; -21.599; -47.691; -54.224; -56.563 | — |
| SECONDARY Summary of 1-OHP Amount Excreted and Absolute Change From Baseline (ug/24 Hour) by Study Group and Study Day (mITT Population) |
0.463; 0.446; 0.592; 0.688; 0.473; 0.446 | <.0001 sig |
| SECONDARY Summary of 1-OHP Amount Excreted Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
14.604; -9.171; -3.632; -22.640; -19.442; -9.058 | — |
| SECONDARY Summary of Urine Mutagenicity and Absolute Change From Baseline (Revertants/24 Hours) by Study Group and Study Day (mITT Population) |
42695.9; 40627.1; 31725.0; 38042.0; 39185.5; 45475.7 | <.0001 sig |
| SECONDARY Summary of Urine Mutagenicity Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
6.059; -40.200; -27.954; -91.239; -93.056; -91.057 | — |
| SECONDARY Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Study Day (mITT Population) |
6.68; 6.81; 7.11; 7.23; 6.98; 6.89 | <.0001 sig |
| SECONDARY Summary of Whole Blood COHb Percent Change From Baseline (%) by Study Group and Study Day (mITT Population) |
0.459; -32.762; -29.807; -73.352; -73.827; -72.424 | — |
| SECONDARY Cigarette Consumption by Study Group and Study Day (mITT Population) |
16.6; 16.7; 17.8; 16.7; 16.8; 16.2 | — |
| SECONDARY Summary of VERVE® Product Usage by Study Group and Study Day (mITT Population) |
4.2; 3.5; 6.3; 3.9; 3.0; 5.8 | — |
| SECONDARY Summary of VERVE® Product Use Duration by Study Group and Study Day (mITT Population) |
16.91; 19.06; 17.37; 16.81; 15.40; 16.38 | — |
| SECONDARY Summary of Total Duration (Min) of VERVE® Product Per Day by Study Group and Study Day (mITT Population) |
66.6; 53.3; 96.4; 62.8; 43.3; 87.0 | — |
| SECONDARY Summary of Response for Willingness to Use Cigarettes Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) |
-3.0; -20.7; -17.0; 0.0; 0.0; 37.3 | — |
| SECONDARY Summary of Response for Willingness to Use the VERVE® Product Again Bipolar VAS Scores for Cigarettes by Category, Study Group and Study Product (mITT Population) |
-36.5; -27.1; -30.7; -27.3; 0.0; 0.0 | — |
Summary
The purpose of this study is to evaluate changes in exposure to selected harmful and potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who partially or completely switch from smoking cigarettes to oral tobacco-derived nicotine (OTDN) products compared to those who continue exclusive smoking cigarettes or stop using all tobacco products.
Eligibility Criteria
Inclusion Criteria
- Voluntary consent to participate in this study documented on the signed informed consent form (ICF).
- Healthy adult males and females 21 to 65 years of age, inclusive, at Screening
- Smoking history of an average of at least 10 but no more than 30 factory manufactured combustible cigarettes daily for at least 1 year prior to Screening. Brief periods (i.e., up to 7 consecutive days) of non-smoking during the 3 months prior to Screening (e.g., due to illness or participation in a study where smoking was prohibited) will be permitted.
- Positive urine cotinine (≥ 500 ng/mL) at Screening.
- Willing to comply with the requirements of the study.
- Willing to use all test products after product trial at Check in.
- Willing and able to abstain from cigarettes from Day 1 through the End of the study.
Exclusion Criteria
- Use of any type of tobacco or nicotine containing products other than manufactured cigarettes (e.g., 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 Check in
- Self-reported puffers (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
- Planning to quit smoking in the next 30 days (from Screening visit).
- 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 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 Investigator.
Data sourced from ClinicalTrials.gov (NCT03692078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.